A clinical study to evaluate efficacy and safety of AHPL/AYTAB/0313 tablet in subjects suffering from osteoarthritis of knee(s).

BACKGROUND: Osteoarthritis (OA) is the most common form of arthritis with unsatisfactory treatment outcomes. OBJECTIVES: To evaluate efficacy and safety of AHPL/AYTAB/0313 tablet in subjects with OA of knee joint. STUDY DESIGN: Prospective, open-label, single-arm clinical study conducted in daily clinical practice setting. METHOD: Subjects were advised to take 2 AHPL/AYTAB/0313 tablets twice daily orally after meals for 180 days. 48 subjects completed the study. The primary endpoints were changes in mean visual analogue scale (VAS) pain score and WOMAC score. Secondary endpoints were quality of life, time to walk 50 feet, knee joint swelling, use of analgesic drug as rescue medicine, and safety parameters. RESULTS: At baseline visit, the mean index knee joint pain (VAS) score was 82.29 ± 15.19, which reduced significantly to 19.38 ± 13.75 on day 180. The mean WOMAC combined score at baseline was 39.94 ± 11.67, which reduced significantly to 09.58 ± 05.77 (76.0%) on day 180. The mean WOMAC pain score at baseline was 09.65 ± 02.91, which reduced significantly to 02.06 ± 01.46 on day 180. The mean WOMAC stiffness score at baseline was 03.48 ± 01.58, which reduced significantly to 00.63 ± 01.08 on day 180. The mean WOMAC difficulty score at baseline was 26.81 ± 09.63, which reduced significantly to 06.90 ± 04.78 on day 180. The mean walking time to walk 50 feet reduced significantly by 40% on day 180. Not a single subject was known to have knee joint swelling from 150 days onwards. Only 5 subjects were using analgesic as rescue medicine on day 180. Twenty-six subjects had adverse events (AEs). Most of the AEs were not associated with the study medication. Vitals and all the safety laboratory parameters were within normal limits both at baseline and on day 180. CONCLUSION: "AHPL/AYTOP/0113" tablet is safe and significantly effective in reducing pain, swelling, and stiffness of knee joints and improving mobility of knee joints in patients with OA. CTRI registration No. is CTRI/2015/09/006177.

An open-label, interventional, single-center, prospective clinical study to evaluate the efficacy and safety of "AHPL/AYTAB/1514" in patients suffering from halitosis.

OBJECTIVES: The main objective of the study was to assess the efficacy and safety of AHPL/AYTAB/1514 tablet in patients suffering from halitosis. METHODOLOGY: Fifty four patients were recruited in the study. Patients were advised to take maximum two tablets or at least one tablet four times a day (depending on tolerability of the drug) orally for 60 days. Patients were called for follow-up on day 15, 30, 45, 60, and 75. Data describing quantitative measures were expressed as mean ± standard deviation comparison of variables representing categorical data were performed using Chi-square test, Student's t-test, or Wilcoxon Sign Rank test. RESULTS: At the end of the treatment, significant reduction in halitosis, gingivitis index, and dental plaque index was observed. Even after stoppage of treatment for 15 days after 60 days of treatment, there was no relapse in halitosis. Few patients experienced sore throat, cough, and common cold during the study, which were resolved with the treatment of AHPL/AYTAB/1514 tablet. No significant change in vital parameters and most of the safety laboratory parameters were observed. No staining on tooth was observed in any patient. Almost all patients showed excellent improvement as per global evaluation done by the physician and patient. Almost all patients showed excellent tolerability to the study drug. Few patients showed mild AE, which were resolved without stoppage of study drug. CONCLUSION: The study provides good evidence in support of the efficacy and safety of the AHPL/AYTAB/1514 tablet in halitosis.

An Open Label, Randomized, Comparative, Parallel Group, Multicenter, Prospective, Interventional, Clinical Study to Evaluate Efficacy and Safety of "AHPL/AYTOP/0113" in Comparison with "Framycetin Sulphate Cream" in Acute Wounds.

OBJECTIVES: The main objective of the present study was to assess efficacy and safety of AHPL/AYTOP/0113 cream, a polyherbal formulation in comparison with Framycetin sulphate cream in acute wounds. METHODOLOGY: It was an open label, randomized, comparative, parallel group and multi-center clinical study. Total 47 subjects were randomly assigned to Group-A (AHPL/AYTOP/0113 cream) and 42 subjects were randomly assigned to Group-B (Framycetin sulphate cream). All the subjects were advised to apply study drug, thrice daily for 21 days or up to complete wound healing (whichever was earlier). All the subjects were called for follow up on days 2, 4, 7, 10, 14, 17 and 21 or up to the day of complete wound healing. Data describing quantitative measures are expressed as mean ± SD. Comparison of variables representing categorical data was performed using Chi-square test. RESULTS: Group-A subjects took significantly less (P < 0.05) i.e., (mean) 7.77 days than (mean) 9.87 days of Group-B subjects for wound healing. At the end of the study, statistically significant better (P < 0.05) results were observed in Group-A than Group-B in mean wound surface area, wound healing parameters and pain associated with wound. Excellent overall efficacy and tolerability was observed in subjects of both the groups. No adverse event or adverse drug reaction was noted in any subject of both the groups. CONCLUSION: AHPL/AYTOP/0113 cream proved to be superior to Framycetin sulphate cream in healing of acute wounds.

Evaluation of Anti-inflammatory and Antimicrobial Activity of AHPL/AYCAP/0413 Capsule.

BACKGROUND: Conventional therapeutic agents used for treatment of Acne are associated with various adverse effects necessitating development of safe and effective alternative therapeutic agents. In this context, a polyherbal formulation AHPL/AYCAP/0413 was developed for treatment of Acne. OBJECTIVES: To evaluate Anti-inflammatory and antimicrobial activity of AHPL/AYCAP/0413. MATERIAL AND METHODS: 1) Anti-inflammatory activity: Anti-inflammatory activity of AHPL/AYCAP/0413 in comparison with Diclofenac was assessed in carrageenan induced rat Paw edema model. 2) Anti-microbial activity for P. acne: Propionibacterium acnes were incubated under anaerobic conditions. Aliquots of molten BHI with glucose agar were used as the agar base. Formulation and clindamycin (10 µg/ml) were introduced in to the Agar wells randomly. 3) Anti-microbial activity for Staphylococcus epidermidis and Staphylococcus aureus: Staphylococcus epidermidis and Staphylococcus aureus were incubated under aerobic conditions at 37°C. TSB with glucose agar was used as the agar base. 0.5ml of formulation and clindamycin (10 µg/ml) were introduced in to the wells randomly. The antibacterial activity was evaluated by measuring zones of inhibition (in mm). RESULT: Significant reduction in rat paw edema (51% inhibition) was observed with formulation AHPL/AYCAP/0413 which was also comparable to that of Diclofenac (58% inhibition). Zone of inhibition for formulation was 18.33 mm, 19.20 mm and 26.30 mm for P. acnes, S. epidermidis and S. aureus respectively. This activity was also comparable to that of Clindamycin. CONCLUSION: AHPL/AYCAP/0413 capsule possesses significant Anti-inflammatory and Anti-microbial activities which further justifies its role in the management of Acne vulgaris. SUMMARY: Anti-inflammatory and antimicrobial activities of polyherbal formulation AHPL/AYCAP/0413 were evaluatedAHPL/AYCAP/0413 contains Guduchi extract (Tinospora cordifolia), Manjishtha extract (Rubia cordifolia), Sariva extract (Hemidesmus indicus), Nimba extract (Azardirachta indica), Khadira extract (Acacia catechu) and Kakmachi extract (Solanum nigrum)Anti-inflammatory activity of AHPL/AYCAP/0413 in comparison with Diclofenac was assessed in carrageenan induced rat Paw edema model. Significant reduction in rat paw edema (51% inhibition) was observed with formulation AHPL/AYCAP/0413 which was also comparable to that of Diclofenac (58% inhibition)Anti-microbial activity of AHPL/AYCAP/0413 was assessed against Propionibacterium acnes, Staphylococcus epidermidis and Staphylococcus aureus. Zone of inhibition for formulation was 18.33 mm, 19.20 mm and 26.30 mm for P. acnes, S. epidermidis and S. aureus respectively indicating 68.42%, 85.71% and 81.17% activity. This activity was also comparable to that of ClindamycinTherefore it is evident that, AHPL/AYCAP/0413 capsule possesses significant Anti-inflammatory and Anti-microbial activities which further justifies its role in the management of Acne vulgaris. Abbreviations Used: mg: Milligram, kg: Kilogram, w/v: Weight by volume, ml: Milliliters, h: Hour, BHI: Brain Heart Infusion, CFU: Colony forming units, µg: Microgram, A.I.: Activity index, P.I.: Percent inhibition, TSB: Trypticsoy Broth, mm: millimeters, P. acnes: Propionibacterium acnes, S. epidermidis: Staphylococcus epidermidis, S. aureus: Staphylococcus aureus.

Evaluation of anti-diabetic activity of AHPL/AYTAB/0513 tablet in streptozotocin induced diabetes in rats.

BACKGROUND: Diabetes is a chronic, progressive disease associated with several complications leading to significant mortality and morbidity. Limitations and drawbacks of the conventional treatment generate need for safer, effective complimentary therapies to prevent complications, and maintain normoglycemic status. AIM AND OBJECTIVES: The aim of this study is to to evaluate antidiabetic activity of AHPL/AYTAB/0513 tablet alone, oral hypoglycemic agents (OHA[s]), and combination of AHPL/AYTAB/0513 tablet and OHA(s) in streptozotocin-induced diabetes in rats. MATERIALS AND METHODS: Totally, ten groups of animals were studied comparatively to evaluate antidiabetic activity of AHPL/AYTAB/0513 tablet, OHA(s), and combination of AHPL/AYTAB/0513 tablet and OHA(s). Blood glucose level (BGL), lipid profile, serum creatinine, serum insulin level, and histopathological characteristics of pancreas were studied to evaluate the efficacy of various formulations. Histopathological examination of kidney and heart was carried out to assess the ability of various formulations in preventing complications of diabetes. RESULTS: There was a significant decrease in mean BGL, serum triglycerides, serum total cholesterol, low-density lipoprotein (LDL), very LDL, and serum creatinine levels in all formulations groups. Significant increase in mean serum insulin level and high-density lipoprotein level was observed when compared to diabetic control (DC) group. Recovery of pancreatic beta cells and prevention of damage to heart and kidney cells was significant in all the formulation groups as compared to DC group. None of the formulations tested in nondiabetic rat showed hypoglycemia suggesting safety of all the formulations. CONCLUSION: AHPL/AYTAB/0513 tablet alone and in combination with OHA(s) can be effectively used in the management of diabetes mellitus. In addition, AHPL/AYTAB/0513 tablet alone and in combination with OHA(s) help in prevention of diabetic complications. As an adjuvant to OHA(s), AHPL/AYTAB/0513 tablet can be more effective.

Evaluation of anti-inflammatory and antimicrobial activity of AHPL/AYTOP/0213 cream.

BACKGROUND: Acne vulgaris is almost a widespread disease occurring in all races. Propionibacterium acnes initiate acne and inflammatory mediators aggravate it. Conventional therapies for acne include comedolytic, anti-inflammatory, and anti-biotic agents. Due to adverse effects of these therapies, people are searching for alternative options. In this context, a polyherbal formulation AHPL/AYTOP/0213 cream was developed for the treatment of Acne. OBJECTIVE: The objective of this study is to study anti-inflammatory and antimicrobial activities of AHPL/AYTOP/0213 cream. MATERIALS AND METHODS: Skin irritation study was conducted on AHPL/AYTOP/0213 cream as per OECD guidelines. (1) Anti-inflammatory activity: Anti-inflammatory activity of AHPL/AYTOP/0213 cream in comparison with diclofenac sodium cream was assessed in carrageenan-induced rat paw edema model. (2) Antimicrobial activity for P. acnes: P. acnes were incubated under anaerobic conditions. Aliquots of molten brain-heart infusion with glucose agar were used as the agar base. Formulation and clindamycin (10 mg/ml) were introduced in to the Agar wells randomly. (3) Antimicrobial activity for Staphylococcus epidermidis and Staphylococcus aureus: bacteria were incubated under aerobic conditions at 37°C. Tryptic soy broth with glucose agar was used as the agar base. A volume of 0.5 ml of formulation and clindamycin (10 mg/ml) were introduced in to the wells randomly. The antibacterial activity was evaluated by measuring zones of inhibition (in mm). RESULTS: AHPL/AYTOP/0213 cream is nonirritant. Significant reduction in rat paw edema (43%) was observed with AHPL/AYTOP/0213 which was also comparable to diclofenac sodium cream (56.09%). Zone of inhibition for formulation was 20.68 mm, 28.20 mm, and 21.40 mm for P. acnes, S. epidermidis and S. aureus, respectively, which was comparable to clindamycin. The minimum inhibitory concentration of formulation AHPL/AYTOP/0213 obtained in anti-microbial study was 2.5 mg/mL. CONCLUSION: AHPL/AYTOP/0213 cream is nonirritant and possesses significant anti-inflammatory and antimicrobial activities, which further justifies its role in the management of acne vulgaris.

Pharmacological Evaluation of Hepatoprotective Activity of AHPL/AYTAB/0613 Tablet in Carbon Tetrachloride-, Ethanol-, and Paracetamol-Induced Hepatotoxicity Models in Wistar Albino Rats.

BACKGROUND: Hepatotoxicity ultimately leads to liver failure. Conventional treatment options for hepatotoxicity are limited and not safe. OBJECTIVE: Formulation AHPL/AYTAB/0613 is developed to provide safer and effective hepatoprotective drug of natural origin. A study was conducted to evaluate hepatoprotective activity of AHPL/AYTAB/0613 (three dosages) in comparison with marketed formulations in carbon tetrachloride (CCl4), ethanol, and paracetamol-induced hepatotoxicity in Wistar albino rats. MATERIALS AND METHODS: Three separate studies were conducted in models of CCl4, ethanol, and paracetamol-induced hepatotoxicity. Seven groups of animals were studied comparatively to evaluate the efficacy of AHPL/AYTAB/0613 in low, medium, and high dosage in comparison with silymarin and a marketed polyherbal formulation. The drugs were orally administered to rats for 10 days in CCl4 model and for 14 days in ethanol and paracetamol models. Animals were weighed periodically. After the study period, blood was tested for serum glutamic-oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT), alkaline phosphatase (ALP), total bilirubin, and total protein levels. Liver tissue of sacrificed animals was examined histopathologically. RESULTS: All the test formulations including all three dosages of AHPL/AYTAB/0613, significantly reduced levels of SGOT, SGPT, ALP, total bilirubin, in CCl4, ethanol, and paracetamol-induced hepatotoxicity models. There was significant increase in total protein level in all the tested formulations. All the test formulations effectively preserved the structural integrity of the hepatocellular membrane and liver cell architecture damaged by CCl4, ethanol, and paracetamol. When compared between groups, no statistically significant difference was observed. It can be concluded that AHPL/AYTAB/0613 possesses hepatoprotective activity in CCl4, ethanol, and paracetamol-induced hepatotoxicity in rats. CONCLUSION: AHPL/AYTAB/0613 can be effectively used as a hepatoprotective agent in the management of hepatitis caused due to various toxins. SUMMARY: A polyherbal formulation AHPL/AYTAB/0613 containing Bhringaraja - Eclipta alba extract, Guduchi - Tinospora cordifolia extract, Daruharidra - Berberis aristata extract, Kakamachi - Solanum nigrum extract, Punarnava - Boerhaavia diffusa extract, Bhumyamalaki - Phyllanthus niruri extract, Kutaki - Picrorhiza kurroa extract, and Kalmegha - Andrograhis paniculata extract was assessed for its hepatoprotective activity. This activity was tested in carbon tetrachloride (CCl4), ethanol, and paracetamol-induced hepatotoxicity models in Wistar albino rats in comparison with two marketed formulations. It was observed that AHPL/AYTAB/0613 significantly reduced levels of serum glutamic-oxaloacetic transaminase, serum glutamic pyruvic transaminase, alkaline phosphatase, total bilirubin and also significantly increased total protein level. All the test formulations effectively preserved the structural integrity of the hepatocellular membrane and liver cell architecture damaged by CCl4, ethanol, and paracetamol. When compared between groups, no statistically significant difference was observed. Therefore, it was concluded that AHPL/AYTAB/0613 possesses hepatoprotective activity in CCl4, ethanol, and paracetamol-induced hepatotoxicity in rats.Abbreviations Used: CCl4: Carbon tetrachloride, SGOT: Serum glutamic-oxaloacetic transaminase, SGPT: Serum glutamic pyruvi transaminase, ALP: Alkaline phosphatase, UDCA: Ursodeoxycholic acid, US: United States, FDA: Food and Drug Administration, PBC: Primary biliary cirrhosis, GSTA1: Glutathione S-transferase A1, GSH: Glutathione, GPx: Glutathione peroxidase, GST: Glutathione S-transferases.

Comparative efficacy of two polyherbal creams with framycetin sulfate on diabetic wound model in rats.

BACKGROUND: Diabetes mellitus is one of the metabolic disorders that impede normal steps of wound healing process. Worldwide, 15% of the 200 million diabetics suffer from diabetic wounds. Diabetic complications, such as foot ulcer, impose major public health burdens worldwide. OBJECTIVE: The present study was carried out to evaluate comparative efficacy of polyherbal creams with framycetin sulfate cream on diabetic rats using incision and excision wound models. MATERIALS AND METHODS: Alloxan (120 mg/kg, intraperitoneal) induced diabetic rat models (incision and excision models) were used to evaluate wound healing effect of cream A, B, and framycetin sulfate. Cream A and B were applied for a period of 10 and 20 days for incision and excision wound models, respectively. Incision wound model was used to assess the effect on breaking strength. Wound contraction and epithelialization period were measured using excision wound model. The data were analyzed by one-way ANOVA followed by Bonferroni post-test. RESULTS: Tensile strength of the animals treated with cream B (941.66 ± 15.36) was found to be significantly greater (P < 0.001) as compared to tensile strength of the animals treated with cream A (825 ± 22.36). Wound treated with cream B was found to heal significantly (P < 0.001) faster (day 17) as compared to wounds treated with framycetin sulfate (day 21). CONCLUSIONS: Cream B was found to be more effective wound healing agent than cream A and framycetin sulfate cream in treating diabetic wounds.

Safety Assessment of TLPL/AY/03/2008, A Polyherbal Formulation in Sprague Dawley Rats.

OBJECTIVES: TLPL/AY/03/2008 is a polyherbal formulation intended for treatment of osteoarthritis, rheumatoid arthritis, lumbago, spondylitis etc., Acute and repeated dose 90-days studies were conducted to evaluate the safety profile of TLPL/AY/03/2008 in rats. MATERIALS AND METHODS: In acute study, TLPL/AY/03/2008 was orally administered to Sprague Dawley rats at 2000 mg/kg. In repeated dose study, TLPL/AY/03/2008 was administered to rats at 200, 500 and 1000 mg/kg through oral gavage for 90 days and assessed for treatment related changes in body weight, feed consumption, hematological, biochemical and pathological parameters. Histopathological examination was conducted for tissues from control and the high dose groups and was extended to target organs from the lower dose and recovery groups. RESULTS: In acute study, the test item did not produce any mortality or adverse clinical signs. In the 90-days oral toxicity study, animals did not exhibit any toxicity symptoms and no deaths were observed. No significant changes were found in hematological and biochemical endpoints. Also, toxicologically significant alterations in relative organ weights were not observed. Microscopic findings of mild to marked, diffuse hepatocellular degeneration (vacuolar changes with granular of cytoplasm and pyknotic nuclei of hepatocytes) was noticed in males at 1000 mg/kg body weight. Animals of recovery group (1000 mg/kg) did not show any changes when compared with control group animals indicating the complete reversal. CONCLUSIONS: Based on the findings of the study, the median lethal dose of TLPL/AY/03/2008 was found to be more than 2000 mg/kg. The No Observed Adverse Effect Level (NOAEL) of TLPL/AY/03/2008 can be considered as 1000 mg/kg in both male and female rats, under the experimental conditions and doses employed.

An open label, prospective, clinical study on a polyherbal formulation in osteoarthritis of knee.

BACKGROUND: Currently, though pharmacological, mechanical, and surgical interventions are used, there is no known cure for osteoarthritis (OA). OBJECTIVES: The main aim of the study was to assess the efficacy and safety of "TLPL/AY/03/2008", a polyherbal formulation on knee joint pain assessed on visual analogue scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). MATERIALS AND METHODS: It was an open label, single center, prospective, clinical study conducted in 36 patients of OA Knee. Two capsules of 'TLPL/AY/03/2008' were given to all patients twice daily orally after meals for 180 days. RESULTS: Data describing quantitative measures are expressed as mean ± SD. Comparison of variables representing categorical data was performed using Chi-square test. The mean joint pain (as assessed on VAS) reduced significantly (59.85%; P < 0.05) and the mean WOMAC combined score, WOMAC pain sub-score, WOMAC stiffness sub-score, and WOMAC difficulty sub-score also reduced significantly at the end of the study. The mean time taken by the patients to walk 50 feet too, was reduced significantly (25.26%) at the end of the study. At the end of 4 months of the treatment, no patient needed paracetamol as rescue medicine to control pain. Most of the patients had shown good overall improvement assessed by the physician and by the patients. Majority of the patients showed excellent tolerability to the study drug. No significant change in most of the safety laboratory parameters was observed at the end of the study. CONCLUSION: The study provides good evidence in support of the efficacy and safety of the 'TLPL/AY/03/2008' in OA of knee.