Validation of standardized polyherbal formulation in the management of type 2 diabetes mellitus: A randomized, double-blind, placebo-controlled trial.

Background: Diabetes is prevalent globally; India stands amongst the first two countries with the highest percentage of adults aged 20-79 years with diabetes in 2021. Anti-diabetic agents and insulin offer profound side effects. Phytoconstituents regulate blood sugar, improve health status and reduce dependency on anti-diabetic medications. This research aims to generate clinical evidence of Diabetic Support Product (GP/PROD/2021/001) in the treatment of type 2 diabetes. Trial design: A randomized, double-blind, placebo-controlled clinical trial was conducted on 150 individuals with type 2 diabetes mellitus. Subjects were divided into two parallel groups and given either GP/PROD/2021/001 or a placebo tablet; 2 tablets twice a day after meals for 90 days. Methods: Interventions were adjuvant to the standard medication. The research objectives were to evaluate changes in fasting and post-meal plasma glucose and HbA1c in patients with type 2 diabetes. Results: In 90 days, GP/PROD/2021/001 group showed a substantial improvement in all key biochemical markers-HbA1c, FBS, and PPBS when compared to the placebo group. A reduced HOMA-IR score suggests reduced insulin resistance. Quality of life improved in GP/PROD/2021/001 group than placebo. On day 90, there was a significant decrease in HbA1c levels in GP/PROD/2021/001 (23.51%) group than placebo (6.21%). The test group reduced their dependency on conventional antidiabetic medication and insulin. Conclusion: It can be concluded from the study that the advanced diabetic support formula (GP/PROD/2021/001) is a safer and more effective option as an adjuvant in the management of diabetes from newly diagnosed to chronic diabetic patients. Trial registration: CTRI/2022/01/039179 [Registered on: 05/01/2022] Trial Registered Prospectively.

Herbal-Based Dressings in Wound Management.

Wound management is one of the major global challenges in recent times, and woundassociated infection has a significant impact on the healthcare economy worldwide. Wounds can be acute or chronic type, also diabetic, trauma, accidental, burn wounds and minor cuts, bruises, and rashes, etc. One of the primary treatment options available in these conditions are the use of suitable dressing materials to cover the wound and accelerate the healing process. Since ancient times, according to archaeological theories, medicinal plants and oils have been employed for the treatment of wounds. Today researchers across the globe are focusing their efforts on fabrication of novel dressing materials that can provide the most effective treatment, easy exchange of nutrients, and absorb exudate from the wounds. Very lately, various research groups are also concentrating on the design and development of herb-loaded wound dressings, as herbal preparations contain numerous phytoconstituents with a broad spectrum of pharmacological properties when compared to synthetic drugs and also due to the perceived notion that herbal products are generally safe, even when administered over prolonged periods. They contain numerous bioactive that can act on the various phases of the wound healing process, providing an ideal environment for the healing process. The present review discusses the numerous approaches that are employed for the preparation of dressing materials incorporated with plant-derived phytoconstituents/extracts. This review also provides an insight into the healing process and wound healing agents derived from medicinal plants and oils. The review can serve as a database for researchers working in this field and can help them to select the most appropriate dressing material for the effective delivery of herbal preparations in the management of wounds.

Safety and efficacy of COROPROTECT kit as an add-on therapy in the management of mild-to-moderate COVID-19: A randomized, placebo-controlled trial.

Background: The constructive role of Ayurveda in managing COVID-19 has been widely discussed, with identified herbs showing immunomodulatory and anti-viral potential. However, clinical trials examining their safety and efficacy are limited. Aim: The aim of this study is to determine the efficacy of COROPROTECT kit, a proprietary Ayurvedic formulation, in COVID-19. Materials and method: Randomized, placebo-controlled trial with 312 mild to moderate hospitalized COVID-19 patients. Groups received COROPROTECT or placebo for 10 days alongside standard care. Results: The outcome measures included the number of days taken to reverse the reverse transcriptase-polymerase chain reaction (RT-PCR) status, reduction in symptoms and inflammatory markers. Fisher exact test was used to analyze the changes between categorical variables, whereas the comparative effect of therapy in both groups on inflammatory markers and safety biochemical parameters was analyzed using Student's t test. A total of 300 patients completed the study without any adverse events. The COROPROTECT kit group exhibited a statistically significant higher percentage of patients testing negative on days 4, 7, and 10 compared to the placebo group. A within group analysis showed that trial group to significantly reduced the levels of C-reactive protein (P = 0.03), lactate dehydrogenase (P < 0.001), and interleukin-6 (P = 0.01). Subjects of the trial group experienced complete relief from cough (69.33%), breathlessness (65.33%), and fatigue (62.67%) within 4 days. In contrast, the placebo group had 20%-40% of participants with mild symptoms persisting until day 10. Conclusion: This study suggests potential future implications, indicating a faster RT-PCR negativity, reduced COVID-19 severity, and inflammatory markers, along with early symptomatic recovery. The COROPROTECT kit proved safe, facilitating an accelerated clinical recovery compared to conventional care.

Herbal Oils for Treatment of Chronic and Diabetic Wounds: A Systematic Review.

BACKGROUND: In the present scenario, diabetes is a growing health challenge, and its occurrence is growing across the globe. Diabetes, with its complications like diabetic wounds, vasculopathy, neuropathy, wound infections, and oxidative stress, is a serious cause of mortality worldwide. INTRODUCTION: Among the various complications, treatment of diabetic foot and ulcers is one of the major concerns in patients who are suffering from diabetes. The causative factors for this condition include increased oxidative stress, high blood glucose levels, vascular insufficiency, and microbial infections, and many a time, if left untreated, it may even lead to amputations of the lower extremities. The present therapy for the treatment of diabetic wounds mainly involves the use of synthetic moieties and other biotechnology-derived biomolecules, including growth factors. Few plant products are also useful in the treatment of wounds. METHODS: Essential oils derived from various herbs are reported to possess significant wound healing potential and promote blood clotting, help to fight infections, and accelerate the wound healing process. Hence, the present review is a systematic analysis of all the available data on the use of the natural oils with their biological source, active phytochemical constituents present, and the probable mechanism of action for the treatment of chronic and diabetic wounds in suitable animal models. A methodical collection of data was performed, and information was searched up to April 2020 in entirety. Key phrases used for the data search include the pathophysiology of wounds, diabetic foot wound and its complications, natural oils for chronic and diabetic wound treatment. RESULTS: This review summarizes the natural oils which are reported in the literature to be beneficial in the treatment of chronic wounds, while some oils have been specifically also studied against wounds in diabetic rats. Essential oils are said to interact with the body pharmacologically, physiologically and psychologically and help in rapid wound healing. However, the majority of the literature studies have demonstrated wound healing activity only in animal models (preclinical data), and further clinical studies are necessary. CONCLUSION: This review provides a platform for further studies on the effective utilization of natural oils in the treatment of chronic and diabetic wounds, especially if oils are to receive credibility in the management of chronic 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.

Design and development of a stable polyherbal formulation based on the results of compatibility studies.

INTRODUCTION: Ayurvedic and herbal medicinal products contain a combination of botanicals; each of these contains a number of chemical compounds that may give the anticipated activity in combination. Therefore, it is very important to analyze and evaluate the compatibility of various active constituents and markers from different medicinal plants for their possible chemical interactions with various excipients at different storage conditions during the development of a stable polyherbal formulation. OBJECTIVE: To study chemical stability of kalmegh (Andrographis paniculata) and kutki (Picrorhiza kurroa) extract for their active markers andrographolide, kutkoside and picroside-I and to develop stable polyherbal formulation based on the incompatibility studies. MATERIALS AND METHODS: The compatibility study was carried out on individual ethanolic extracts of these two plants along with the commonly used excipients in the ratio of 1:1 at 40 ± 2°C and 75 ± 5% relative humidity and at a refrigeration temperature of 5 ± 1°C for initial, 7-, 15- and 30-day intervals. The analysis was carried out using the validated reverse phase-high-performance liquid chromatography methods. A stable tablet dosage form was developed based on the results of these studies. RESULT: The study suggested that the active markers of kutki (kutkoside and picroside-I) were found to be degraded in the presence of the kalmegh extract. However, the active marker of the kalmegh extract (andrographolide) was found to be stable. Both the extracts showed excellent compatibility with all the excipients used in making this formulation. No significant decrease in the kutkoside and picroside-I content from the formulation was observed. CONCLUSION: By separate granulation process the exposure of both the extracts can be minimized thus avoiding the degradation of active markers.