Nicotine Free Herbal Composition for Smoking De-Addiction - A Placebo Controlled, Double Blind, Randomized, Multicentric Clinical Study.

Background: Smoking is a major predisposing factor for many health problems including cancers, vascular disorders, etc., To quit smoking is the only solution to prevent them. Various medicinal and non-medicinal methods are used worldwide for the same. The present study evaluates the effect of a nicotine free herbal formulation containing ingredients like Mucuna pruriens, Withania somnifera, Bacopa monnieri, etc., for cessation of smoking and its effects on other health parameters related to smoking. Materials and Methods: The present study was a placebo controlled, double blind, randomized, and multi-centric clinical study conducted at three clinical sites in India. After ethical approval and informed consent, all participants were given Smotect Tablets or Placebo tablets in a dose of 2 tablets twice daily for 90 days. A total of 103 participants (52 in trial group and 51 in placebo group) completed the study. Evaluation of cessation of smoking was done along with other parameters like measurement of lung capacity, clinical assessment, and laboratory investigations before and after the study. Results: A significant reduction in smoking as well as in the alveolar Carbon monoxide (p < 0.05) and Carboxyhemoglobin levels (p < 0.05) were observed with the use of Smotect tablets as compared to placebo over a period of 90 days. Significant improvement was also observed in quality of life, energy and stamina levels, and reduction of stress level. Smotect tablets were found to be safe without causing any adverse effects. Conclusion: Smotect Tablets is an effective and safe remedy for cessation of smoking and reducing other effects related to smoking.

Vasant Kusmakar Ras, an ayurvedic herbo-mineral formulation prevents the development of diabetic retinopathy in rats.

BACKGROUND: Diabetic retinopathy is a slow progressing complication of diabetes mellitus with multifactorial aetiology affecting approximately 80% of diabetics worldwide. Chronic hyperglycemic milieu of Diabetes induces biochemical changes which contribute to the pathogenesis of Diabetic retinopathy. OBJECTIVE: The present study examined the protective effect of Vasant Kusumakar Ras, an Ayurvedic herbo-mineral formulation, in diabetic retinopathy. MATERIALS AND METHODS: Diabetes was induced in rats by intraperitoneal injection of streptozotocin (45 mg/kg). Rats were kept without any treatment for period of three weeks for induction of Diabetic retinopathy followed by treatment with Vasant Kusumakar Ras (11.25 mg/kg, p.o) for further 5 weeks. Fasting blood glucose levels, lipid profile and HbA1c were determined. Eye tissue homogenates were subjected to biochemical analysis to determine the levels of oxidative stress parameters (superoxide dismutase, catalase, reduced glutathione, lipid peroxidation), vascular endothelial growth factor and aldose reductase activity. Histopathological analysis of retinal tissue was conducted using Hematoxylin and Eosin staining. RESULTS: Vasant Kusumakar Ras treatment restored serum lipid profile which was altered in diabetic rats. Treatment with Vasant Kusumakar Ras significantly ameliorated the oxidative stress in eye tissue resulting in decreased lipid peroxidation and increase in endogenous antioxidant levels. Levels of aldose reductase and vascular endothelial growth factor in eye tissue were significantly decreased in Vasant Kusumakar Ras treated rats. Hematoxylin and Eosin staining indicated that the Vasant Kusumakar Ras treatment significantly restored the normal architecture of the retinal tissue. CONCLUSION: Vasant Kusumakar Ras exhibits protective effect and prevents the development of Diabetic retinopathy through its effects on multiple biochemical pathways implicated in pathogenesis of Diabetic retinopathy.

An open-label, prospective, multicenter, clinical study to evaluate efficacy of Ayuartis capsules in patients suffering from osteoarthritis of the knee(s).

BACKGROUND: The management of chronic degenerative joint disorders such as osteoarthritis (OA) with ayurvedic medicines provides a safe and effective alternative. Ayurvedic medicines possess analgesic, anti-inflammatory, anti-oxidant and immunomodulator activities. AIMS: The main aim of the study was to assess the efficacy of Ayuartis capsule in patients suffering from OA of the knee(s). MATERIALS AND METHODS: Thirty-one patients suffering from OA knee(s) were recruited after evaluating them as per inclusion/exclusion criteria. Patients were advised to take two Ayuartis capsules twice daily orally for 90 days. Knee joint(s) pain was assessed on the Visual Analog Scale. Patients' joint pain, stiffness, and physical functions were assessed on the Western Ontario McMaster University Osteoarthritis (WOMAC) index. Quality of life (QOL) and the time required to walk 50 feet was evaluated. Patients were called for follow-up visits on every 15th day till 90 days. Adverse events and vitals were recorded at every visit. Safety laboratory investigations were done before and after the completion of trial. STATISTICAL ANALYSIS: Data describing quantitative measures are expressed as mean ± standard deviation. The comparison of variables representing categorical data was performed using pair t-test. RESULTS: The mean joint pain reduced significantly by 53.82% on day 90. The mean WOMAC combined score, pain score, stiffness score and difficulty score reduced significantly by 50.88%, 54.96%, 58.76% and 49.02%, respectively on day 90. A significant improvement was observed in mean QOL of patients. A significant reduction in mean time required to walk 50 feet was observed. Majority of the patients had shown good overall improvement and excellent tolerability to the trial drug. CONCLUSION: Ayuartis capsule is a safe and effective medicine for the treatment of OA of the knee(s).