An Open-labeled Clinical Study to Evaluate the Safety and Efficacy of “Anuloma DS” in Improving Constipation

Background: Constipation is a common gastrointestinal problem in the general population. Despite a plethora of well-established and safe treatment options, the improvement is not satisfactory for many patients. This has prompted interest in alternative therapeutic strategies for constipation. Methods: This open-label, non-comparative single-arm clinical study evaluated the efficacy and safety of the polyherbal formulation “Anuloma DS”, 1 tablet daily at bedtime, in improving bowel movements in 30 adult patients with functional constipation. Patients were evaluated at baseline (Visit 1, Day 0) and follow-ups during Visit 2 (Day 7 ± 2), Visit 3 (Day 14 ± 2) and Visit 4 (End of the Study) at Day 30 ± 2. Results: There was a significant increase in the mean of spontaneous bowel movement every week from day 7 to days 14 and 30. All constipation symptoms such as abdominal bloating (aadmana), abdominal pain/discomfort (aanaha), feeling of incomplete evacuation and straining during passing stool improved significantly as did the SGA and the PGA scores. Conclusion: Anuloma DS is highly effective for the treatment of chronic functional constipation. No treatment-related side effects were reported by the study participants.

Efficacy and Safety of Stomatab Capsules® in Improving Oral Health in Recurrent Aphthous Stomatitis: An Open-labeled Clinical Study

Background: Recurrent aphthous stomatitis (RAS) is a common ulcerative disease of the oral mucosa, which is difficult to treat. In Ayurveda, several medicinal plants have been evaluated for their anti-inflammatory and antioxidant effects in many oral diseases as an alternative for modern medicines. Method: A study with open-label, non-comparative single-arm design was conducted to evaluate the efficacy of “Stomatab” capsules in improving oral health in 30 subjects with RAS. The secondary objectives were to assess the improvement in oral health and tolerability of the herbal formulation. Subjects were instructed to take one capsule thrice daily after meals for 14 days. Patients were evaluated at three assessment points: screening and baseline (Visit 1, Day 0) with follow-ups done at Visit 2 (Day 5 ± 2) and Visit 3 at the end of the study (Day 14 ± 2). Results: There was a significant reduction in the mean ulcer size from 3.66 ± 1.27 mm (V1) to 0.64 ± 0.78 (V3). The mean number of ulcers reduced from 1.97 ± 0.72 (V1) to 0.90 ± 0.66 (V3). Significant improvement in ulcer-related symptoms of pain (Ruja), burning sensation (Daha) and redness (Raktavarnata) was noted. The total ulcer symptom scores decreased from 7.67 ± 2.38 (V1) to 0.63 ± 0.56 (V3). No side effects were reported by the study participants. Conclusion: These results show that the polyherbal formulation “Stomatab” capsule is safe and effective for the treatment of RAS.

Anti-infective potential of a quorum modulatory polyherbal extract (panchvalkal) against certain pathogenic bacteria

BackgroundIn view of the gravity of the problem of antimicrobial resistance among pathogenic bacteria against conventional bactericidal agents, investigation on alternative approaches to combat bacterial infections is warranted.ObjectiveCurrent study aimed at investigating anti-infective potential of a polyherbal ayurvedic formulation namely panchvalkal against three different pathogenic bacteria.Materials and methodsThe panchvalkal formulation available as Pentaphyte P5® was tested for its possible in vitro quorum-modulatory potential against Chromobacterium violaceum, Serratia marcescens, and Staphylococcus aureus through broth dilution assay. Invivo efficacy was demonstrated employing Caenorhabditis elegans as the model host for test pathogens.ResultsThis formulation was found to exert quorum-modulatory effect on C. violaceum, S. marcescens, and S. aureus at 250–750 μg/ml. Besides altering production of the quorum sensing-regulated pigments in these bacteria, the test formulation also had in vitro effect on antibiotic susceptibility, catalase activity and haemolytic potential of the pathogens. Invivo assay confirmed the protective effect of this panchvalkal formulation on C. elegans, when challenged with the pathogenic bacteria. Repeated exposure of S. aureus to panchvalkal did not induce resistance in this bacterium.ConclusionTo the best of our awareness, this the first report on quorum-modulatory potential of panchvalkal formulation, validating the anti-infective potential and moderate prebiotic property of this polyherbal preparation.

Bhallatakadi Ghrita: Development and evaluation with reference to Murcchana and Shata-Dhauta process

Background: Ayurveda is primarily based upon use of herbs either singly or in combination (polyherbal).The cow ghee (clarified butterfat) is considered as a precious base for preparing medicines in Ayurveda.Processing of ghee with plant ingredients is renowned for enhancing their therapeutic efficacy.Objective: In present research work, the attempt was made to develop cow ghee based PolyherbalBhallatakadi Ghrita formulations and evaluate them with reference to ‘Murcchana’ and ‘Shata-Dhauta’process.Materials and methods: The research plants were identified, procured, authenticated and processed. Theextracts of plant materials were prepared and used for development of Polyherbal Bhallatakadi Ghrita(PHBG), Polyherbal Bhallatakadi Murcchita Ghrita and Polyherbal Bhallatakadi Shata-Dhauta Ghrita formulations as per Ayurvedic procedures. The prepared ghrita formulations were subjected to organoleptic(colour, odour, taste, appearance and touch), physicochemical (pH, viscosity, moisture content, specificgravity, refractive index, acid value, saponification value, iodine value, peroxide value, Rechert Meisslvalue and Polenske value) evaluation, in-vitro antioxidant and GC-MS analysis. The accelerated and realtime stability studies were carried out to determine shelf life of ghrita formulations.Results: The results of evaluations indicate that, developed PHBG formulations retained the organolepticand physicochemical characteristics of ghee. The shelf life of formulations was found to be in the range of1.6 to 3.3 years at accelerated and 2.2 to 3.8 years at real time stability conditions. All ghrita formulationsexhibited antioxidant activity in dose dependent manner.Conclusion: The standardization or evaluation of Polyherbal Bhallatakadi Ghrita formulations was foundto be crucial for the establishment of a steady biological, chemical or simply a quality assurance profile ofthe drugs

Modulatory effect of Kolin PlusTM, a polyherbal formulation on muscle growth development in choline deficient diet model of broilers: a genomic analysis using microarray

Background:The present study was conducted to elucidate the genes and its associated pathways delineating the growth-promoting potential of polyherbal formulation (PHF), Kolin PlusTMusing microarray in Cobb 430 broiler chickens. Methods:Microarray was performed forfour groups, namely, normal diet (ND) as G1, choline chloride deficient (CCD) diet as G2, choline chloride (CCL, 400 g/ton) as G3 and PHF (400 g/ton) as G4. Breast muscle samples were collected, and the growth-related gene expression profile was measured using the Agilent microarray platform.Results:Totally 2900 differentially expressed genes (DEGs) in muscle tissue sample was revealed using hierarchical clustering based on the similarity of their expression profiles, which further allows the user to pick out groups of similar genes. Among them, 1000, 364 and 481 genes were significantly upregulated and 244, 485 and 326 genes were significantly downregulated between ND and CCD, CCL and CCD, PHF and CCD respectively. Furthermore, some of the focused genes (CSRP3, SOX10, BCO1, CALB1, LMOD2, KLF15, CTHRC1, PHGDH, UTS2R, and ANKRD2) were significantly (p<0.05) modulated by PHF (400 g/ton) supplementation in birds fed with CCD diet. These genes play an essential role in protein translation, energy metabolism, and muscle growth promotion.Conclusions:It may be concluded that supplementation of PHF at 400 g/ton of feed could positively influence the certain focused genes associated with muscle growth promotion, which favoursthe productive phenotypic response in broiler chickens fed with CCD diet

A Review On The Anti-diabetic (pramehahara) Action Of An Ayurvedic Polyherbal Formulation -nisakatakadi Kwatha

Type 2 Diabetes mellitus is one of the major diseases affecting the population world wide. India is no exception with its 69. 1 million people affected as per current statistics. So in the current scenario, search for effective anti diabetic drugs are on the rise. The management of diabetes with modern system of medicine, inspite of many advances still remains unsatisfactory. This led to the search of safe, effective and cheaper herbal remedies. Such remedies can be explored from the huge wealth of Ayurveda which has been practice in India since centuries. One such effective anti diabetic Ayurvedic formulation that has been in use in Kerala by traditional vaidyas since long ago is Nisakatakadi kwatha. It is mentioned in one of the traditional Malayalam text, Sahasrayoga. It is a formulation consisting of 8 drugs viz. Nisa, Kataka, Amalaki, Paranthi, Lodhra, Bhadrika, Saptachakra and Ushira. In this review an attempt has been made to analyse the anti diabetic (pramehahara) action of this formulation by reviewing the pharmacological properties and the recent research updates on each of these 8 drugs by reviewing textbooks of Ayurveda and journal articles. This review also aims to familiarize this effective formulation to the Ayurvedic fraternity and to the general public.

Comparative Antidiabetic Potential Assessment Of Herbal Formulation Of Gymnemic Acid And Curcumin

Standardization of polyherbal formulations with respect to bioactive phytocompounds is the need of the time for registration and marketing authorization in developed countries. This has prompted to prepare and evaluate a standardized bioactive phyotcompounds conintaining formulation. The study aims at development and screening of a standardized antidiabetic suspension containing active isolated phytoconstituents targeting better therapeutic effect with reduced bioburden. Suspension of isolated gymnemic acid and curcumin (GCS) was prepared, evaluated and authenticated by TLC and HPTLC. Antidiabetic efficacy of GCS was screened against alloxan induced diabetes on rats following 28 days of treatment comparative to Hyponidd tablet and Madhumehari granules. Body weight, relative organ weight, blood glucose, cholesterol (TC), triglyceride (TG), high density lipoprotein (HDL), low density lipoprotein (LDL) and very low density lipoprotein (VLDL) level was measured. The formulation having pH 6.0, refractive index 1.41 and 45.58 mg/ml total solid content showed high alcohol and water soluble extractive value. The GCS treatment normalized liver and kidney weight, decreased body weight gain, TC, TG, LDL and VLDL level along with an increase in HDL level. Study outcome signifies similar antidiabetic potential of standardized formulation GCS compared to marketed Polyherbal formulation with antihyperlipidemic activity signifying as a promising natural and safe remedy for the prevention of diabetic complications.

Comparative Evaluation of Efficacy and Safety of Herbal Preparation vis-a-vis Beclomethasone Cream on Radiation Induced Skin Injury in Head and Neck Carcinoma Patients Receiving Radiotherapy or Chemoradiation in Oncology Department at a Tertiary Care Hospital

Introduction: Radiation mitigators are the compounds whichcan minimize or ameliorate post irradiation-toxicity providedthey are administered before the onset of toxic symptoms.Hence, there is an urgent need to prevent harmful effectssecondary to ionizing radiations.Material and Methods: Sixty patients of Head and neckcarcinoma more than 18 years of age of either sex and willingto give informed consent were included in the study. In Group1, 30 patients received the Beclomethasone cream that wastopically applied from the day-1 of radiotherapy till 4-weeksafter completion of radiotherapy, whereas In Group-2, 30patients received the local application of the herbal paste fromthe day-1 of radiotherapy till 4-weeks after completion ofradiotherapy.Results: For measuring radiation-induced reactions, nonparametric test like chi-square test was applied and number ofpatients in different grades was calculated as per RTOGcriteria. Similarly for measuring radiation-induced mucosalreactions, chi-square test was applied and number of patientsin different grades was calculated as per RTOG-criteria.Conclusion: Present study revealed a marked beneficialeffects of herbal paste containing Azadirachta indica, aloevera, Ocimum sanctum and Curcuma longa on radiationinduced skin injury in patients with Head and neck carcinomaas compared to topical Beclomethasone cream.

Status of Indian medicinal plants in the International Union for Conservation of Nature and the future of Ayurvedic drugs: Shouldn't think about Ayurvedic fundamentals? / 中西医结合学报

The present market for herbal drugs is estimated about ₹40 billion, which is expected to increase by 16% in next 3-4 years. The current production of many Ayurvedic herbs is less than their market demand, which incentivizes adulteration in the Ayurvedic drug supply chain. The present work aims to highlight the most used Ayurvedic plants that have been listed in the International Union for Conservation of Nature's "red list" of endangered or vulnerable plants. The future of Ayurvedic medicines from these listed plants is uncertain, as the collection of herbs from their natural habitat is prohibited and their cultivation does not meet market demands. Many of these plants, such as Taxus baccata and T. wallichiana, are endangered and are only grown in their natural habitats; their cultivation in other areas is impractical. This is the present state, and will worsen as demand continues to grow, with increasing populations and increasing adoption of this system of medicine. It is possible that in coming years most of the Ayurvedic drugs will be adulterated, and will cause only side effects rather than the therapeutic effects. The Ayurvedic fundamentals are under-explored areas where the Ayurvedic practitioners and research scientists can work together. The scientific work on the basic principles will unravel many unknown or little-known facts of this ancient science. Hence, the present review emphasizes the conservation of Ayurvedic herbs, minimization of the use of medicinal plants and the promotion of the research based on Ayurvedic fundamentals.

Relative Organ Weights and Histological Changes in Wistar Rats Treated with a South East Nigerian Polyherbal Formulation (Ajumbise)

Background and Aim: Ajumbise is a polyherbal formulation used in Southeast Nigeria for enhancing labour, facilitating the expulsion of retained placenta, relieving menstrual and post-delivery pains and promoting involution of the uterus. In this study, the effect of the Polyherbal formulation on body weights, relative organ weights and liver and kidney histology was evaluated.Methods: Forty rats were divided into four groups of ten rats each and were assigned daily oral administration of the extract for 28 days. While group 1 served as the control, groups 2, 3 and 4 were administered increasing doses of the extract. At the end of treatment organs were collected for histological analysis respectively. Students’s t-test at 95% level of significance was used for statistical analysis.Results: Acute toxicity study result indicated zero mortality in all groups within the 24 hours of thestudy, even at a dose of 6000 mg/kg body weight. Body weight gain was significantly lowered in all treatment groups when compared with the control group (P<0.05). Relative liver weight did not significantly differ from that of the control except for the 800 mg/kg treated group where significant elevation was observed (P< 0.05). Relative kidney weights was significantly elevated in groups treated with 200 and 400 mg/kg (P<0.05). No significant histological changes were observed between treatment groups and control except for 800 mg/kg treated group where some inflammatory cells were observed masking the features of the portal triad. The arrangement of the hepatocytes, architecture of the portal triad comprising of the bile duct, hepatic portal vein and hepatic artery and central vein were essentially normal and had neither congestions nor necrosis. Histological presentations of the kidneys in all groups were normal and did not significantly differ from control.Conclusion: We therefore conclude that Ajumbise polyherbal may be safe at low to moderate dosses and at such doses does not pose any threat to the liver and kidney cells.

In vitro Anti-cholinesterase and Anti-oxidant Activity of Three Standardised Polyherbal Products Used for Memory Enhancing in Ethnomedicine of South-East Nigeria

Background: Polyherbal standardised extracts used in ethnomedicine of Eastern Nigeria for memory improvements were evaluated for anti-cholinesterases and anti-oxidant properties.Methods: Anti-cholinesterase, anti-oxidant, and total phenolic and flavonoid contents were established using standard procedures.Results: The three polyherbal extracts exhibited significant concentration dependent acetylcholinesterase (AChE) inhibitory activity (P = 0.001). The highest AChE inhibition was observed with the Neocare Herbal Tea (NHT) with 99.7% (IC50 = 324 μg/mL); whereas the Herbalin Complex Tea (HCT) and Phytoblis Herbal Tea (PHT) exhibited 73.8% (IC50 = 0.2 μg/mL) and 60.6% (IC50 = 0.7 μg/mL) inhibition, respectively, relative to eserine at 100% inhibition (IC50 = 0.9 μg/mL) at 200 μg/mL. The order of percentage increase in inhibition of AChE was NHT > HCT > PHT; while the order of decrease in potency was HCT > PHT > NHT.Radical scavenging activities of HCT, NHT and PHT were 82.13% (IC50 = 0.08 μg/mL), 77.43% (IC50 = 0.01 μg/mL) and 76.28% (IC50 = 0.3 μg/mL), respectively, at 1 mg/mL concentrations. The reducing power revealed a dose-dependent effect, with NHT > PHT > HCT. The order of total phenolics content in the extracts were PHT > HCT > NHT, and for total flavonoids content: PHT > NHT > HCT.Conclusion: The three polyherbal standardised products possess significant acetylcholinesterase inhibitory activity and secondary metabolites that could collectively contribute to their memory-enhancing effects.

The efficacy of polyherbal formulation of Moringa oleifera, Viola odorata, Allium sativum against microbes- synergistic effect.

The purpose of our present study is to test antimicrobial and antifungal activity of polyherbal formulations. The testing of the antimicrobial activity on polyhernal formulation was done against gram positive (Staphylococcus aureus, Bacillus subtilis) and gram negative (Salmonella typhi, Escherichia coli,) bacteria. The testing of antifungal activity was done against Aspergillus niger and Candida albicans with different combinations of polyherbal formulation. The microorganism to be tested was grown in relevant nutritional media. The solvent used for the extraction of Moringa oleifera, Viola odorata, Allium sativum was methanol. These methanolic extracts of chosen plants were further used in specific proportions for the preparation of polyherbal formulation (PF-1, PF-2, and PF-3). The resultant compositions were further used to check the efficacy against selected experimental microorganisms. PF-3 showed the significant high zone of inhibition against all the experimental microorganisms as compared to the other two combinations PF-1 and PF-2. Thus, the result has revealed that the antimicrobial activity is due to the synergistic effect of secondary metabolites present in these selected plants.

Antimalarial properties of SAABMAL®: an ethnomedicinal polyherbal formulation for the treatment of uncomplicated malaria infection in the tropics.

Background & objectives: Malaria is a serious problem in the countries of the developing world. As the malaria parasite has become resistant to most of the antimalaria drugs available currently, there is a need to search for newer drugs. This study reports the pharmaceutical quality and in vivo antimalarial activities of a polyherbal formulation (SAABMAL®) used as malarial remedy in Nigeria. Methods: The antiplasmodial activity of SAABMAL® was determined by using the 4-day suppressive test in Plasmodium berghei-infected mice. The formulation was tried on three different experimental animal models for in vivo antimalarial activities, which are prophylactic, suppressive and curative in mice. Chloroquine and pyrimethamine were used as standard drugs for comparison. Results: The suppressive study showed that, SAABMAL® (200 and 400 mg/kg/bw) significantly (p<0.01) produced a suppression (29.39 - 100%) of parasitaemia in a dose-dependent manner, while the curative study showed that SAABMAL® at 400 mg significantly (p<0.01) reduced (95.80%) parasitaemia compared with controls. The mean survival time of SAABMAL®-treated groups (100 and 200 mg/kg) was higher than that of the chloroquine-treated group. Histopathologically, no changes were found in the spleen of both untreated and treated groups. SAABMAL® capsules were of good mechanical properties with low weight variation and high degree of content mass uniformity. Interpretation & conclusions: The results obtained in this study showed the efficacy of SAABMAL®, a herbal antimalarial formulation against chloroquine sensitive malaria and its potential use in the treatment of uncomplicated malaria infection. Further studies need to be done in humans to test its efficacy and safety for its potential use as an antimalarial drug.

Antiplasmodial activity of traditional polyherbal remedy from Odisha, India:Their potential for prophylactic use

Objective: To evaluate the potential prophylactic activity of traditional polyherbal remedy against malaria. Methods: A traditional polyherbal remedy against malaria from Odisha, India was evaluated for its potential prophylactic activity using in vitro hepatic cell lines assay and the murine malaria system Plasmodium yoelii yoelii/Anopheles stephensi. Results: The polyherbal extract inhibited the Plasmodium yoelii hepatic stages in vitro (IC50 0.74 mg/mL), a therapeutic index of 9.54. In mice treated with the aqueous extract (2 000 mg/kg/day), peak parasitaemia values were 81% lower in the experimental 2.35% ± 0.14% as compared to controls 12.62% ± 0.52% (P Conclusions: The observations provide a proof of concept for a traditional malaria prophylactic remedy used by tribal populations in India.

Antiplasmodial activity of traditional polyherbal remedy from Odisha, India: Their potential for prophylactic use

Objective: To evaluate the potential prophylactic activity of traditional polyherbal remedy against malaria. Methods: A traditional polyherbal remedy against malaria from Odisha, India was evaluated for its potential prophylactic activity using in vitro hepatic cell lines assay and the murine malaria system Plasmodium yoelii yoelii/Anopheles stephensi. Results: The polyherbal extract inhibited the Plasmodium yoelii hepatic stages in vitro (IC

Evaluation of Microbial Purity and Acute and Sub-acute Toxicities of a Nigerian Commercial Polyherbal Formulation Used in the Treatment of Diabetes Mellitus.

Objective: This study evaluated acute and sub-acute toxicities in rodents and microbial purity of a polyherbal formulation, Bobwell® popular among the natives for the management of diabetes mellitus (DM). It was prepared with unspecified quantities of the following plant materials viz. Gongronema latifolium. Garcinia kola, Vernonia amgydalina, Sphenocentrum jollyanum and Kigelia africana leaves. Materials and Methods: Microbial purity was evaluated on some bacterial and fungal organisms using appropriate diagnostic media. Toxicity of the polyherbal preparation was evaluated in Swiss albino mice by administering to the animals graded oral doses of the lyophilized preparation in the ranges of 1.0 to 20.0 g/kg body weight (bwt) and observed for changes. Wistar rats were also fed with different doses of the lyophilized formulation for 30 days and the effects on the biochemical profiles and haematological parameters were evaluated. Results: The purity evaluation test revealed presence of some bacterial organisms with the load within officially acceptable limits except Escherichia coli having a load of 1.50x102 cfu/ml while no fungal organisms were observed. The median acute toxicity value (LD50) of the polyherbal medicine was determined to be 15.2 g/kg bwt. There was significant increase (P ≤0.05) in the body weight of the animals treated with the highest dose of the formulation compared to the control. The biochemical parameters showed marked decrease in the plasma glucose level compared to the control. Increase in creatinine level was observed only in the animals that received the highest dose of the formulation while aspartate aminotransferase (AST) decreased significantly. On the other hand, alanine aminotransferase (ALT) exhibited significant increased (P ≤0.05) at the highest dose. The photomicrograph of hepatic tissue showed focal necro-inflammation around the portal hepatics. There was marked increase in the haemoglobin level and in the red blood cell (RBC) count at the highest doses. There was also significant increase in white blood cells (WBC). Conclusion: The high LD50 value indicated that the polyherbal preparations could be safe for use but its safety was negated by high presence of E coli load. Although the formulation showed good hypoglycaemic activity and beneficial effects on cardiovascular risk factors, at the highest dose, the formulation exhibited deleterious effect on the hepatic tissue.

Anti-diabetic and antihyperlipidemic effect of allopolyherbal formulation in OGTT and STZ-induced diabetic rat model.

The present study was undertaken to evaluate the antidiabetic and antihyperlipidemic activities of Allopolyherbal formulation (APHF) consisting of combinations of three well known medicinal plants used in traditional medicines (Trigonella foenum graceum, Momordica charantia, Aegle marmelos) and synthetic oral hypoglycaemic drug (Glipizide-GL). The optimized combination of lyophilized hydro-alcoholic extracts of drugs was 2:2:1 using OGTT model. The optimized PHF was simultaneously administered with GL and optimized using OGTT model in diabetic rats and further studied in STZ-induced diabetic rats for 21 days. The results (serum glucose level, lipid profile, hepatic enzymes and body weight) were compared with the standard drug GL (10 mg/kg body wt). The optimized APHF (500+5 mg/kg body wt) has shown significant antihyperglycemic and antihyperlipidemic activities. The results were comparable with the standard; even better than the GL (10 mg/kg body wt) alone. The proposed hypothesis has reduced the no. of drug components from eight to three and dose almost 50 % of both PHF and GL which fulfil the FDA requirements for export. Thus the developed APHF will be an ideal alternative for the existing hypoglycemic formulations in the market with an additional advantage of hypolipidemic effect and minimizing the cardiovascular risk factors associated with diabetes.

Assessment of analgesic and antipyretic activity of traditional formula used in the treatment of seasonal infections.

Traditional treatments and medicines are the main sometimes the only source of health care for millions of people living in rural areas of developing countries. The aim of the present study is to investigate the analgesic and antipyretic activity of individual plant extracts and poly-herbal formula [PHF] made in to liquid dosage form of three different doses in albino rats. The plant materials were extracted in boiling distilled water for six hours, filtered, concentrated and dried. The aqueous extracts were prepared in to poly-herbal liquid dosage form by using water, glycerol mixture and acacia 2% in three different preparation of varying extract doses.1ml of above preparations orally fed for investigation. Pentozocine and paracetamol was used as standard drugs respectively. For individual plants the extracts were suspended in 2% acacia solution and performed. The results of analgesic and anti-pyretic activity of PHF 1 and PHF 2 showed significant results (P<0.01 and P<0.05 respectively) and PHF3 did not show any significant results. In the individual plant extracts slightly significant activity (P<0.05) was observed.

Evident stabilization of the clinical profile in HIV/AIDS as evaluated in an open label clinical trial using a polyherbal formulation.

Background & objectives: The complementary and alternative medicines (CAM) have not been systematically evaluated for the management of HIV/AIDS patients. In a prospective, single-site, open-label, non-randomized, controlled, pilot trial, we evaluated a polyherbal formulation (PHF) for its safety and efficacy in treating subjects with HIV-AIDS. Methods: A total of 32 and 31 subjects were enrolled under the PHF and highly active antiretroviral treatment (HAART) arms, respectively, and followed up for a period of 24 months. Plasma viral RNA, CD4 cell count and blood chemistry were monitored at 3-month intervals. Following mid-term safety evaluation, 12 subjects from the PHF arm were shifted to HAART and were followed separately as PHF-to-HAART arm, for the rest of the period. Results: The HAART arm was characterized by significant improvements in CD4 cell count (154.4 cells/μl/year, P<0.001) and reduction in plasma viral load within 3 to 6 months (-0.431+ 0.004 log10 IU/month, P<0.001). In contrast, the PHF arm showed a profile of CD4 cell loss at remarkably slower kinetics (14.3 cells/μl/year, P=0.021) and insignificant reduction in the viral load. The PHF and HAART arms did not differ significantly in the occurrence of AIDS-related illnesses over the study period of 24 months. In the PHF-to-HAART arm, the rates of CD4 count and reduction in viral load were significant and comparable to that of the HAART group. In the PHF arm, at 1 month, a significant increase in CD4 cell count and a concomitant decrease in viral load were seen. Interpretation & conclusions: The PHF appears to have provided protection by delaying the kinetics of CD4 cell reduction. Given the several study limitations, drawing assertive inferences from the data is challenging. Future studies with a stringent study design are warranted to confirm these findings.

RP-HPLC Method Development and Validation of Gallic acid in Polyherbal Tablet Formulation.

A new simple, accurate, precise, sensitive and validated RP-HPLC method was developed for the estimation of Gallic acid in bulk and pharmaceutical tablet dosage form. The chromatographic conditions used for the separation was Phenomenex Luna C18 (2) (4.6 x 250mm, 5μ), rheodyne manual injector with capacity of 20μL and mobile phase comprised of Water: Acetonitrile (80: 20%v/v) and pH is maintained at 3.00 using Ophosphoric acid (OPA). The flow rate was 1.0mL/min with detection at 272nm. The retention time was found to be 3.60min. The linearity was found to be in the range of 0.5-50μg/mL for Gallic acid with correlation coefficient of 0.9994. The proposed method is accurate with 99.97% - 100.58 % recovery and precise (%RSD of repeatability, intra-day and inter-day variations were 1.26%, 0.48-0.95%, 0.80-1.83%). The Limit of Detection (LOD) and Limit of Quantification (LOQ) were found to be 0.0178μg/mL and 0.0539μg/mL respectively. The amount of Gallic acid in Polyherbal tablet was found to be 1.63%.