Safety and Efficacy of the Ayurvedic Formulation Guduchi Ghana Vati as a Preventive Remedy in COVID-19.

Background and objectives Guduchi (Tinospora cordifolia) is a well-known Ayurvedic herb used as a preventive and curative remedy for various infections and immunity-related conditions. This study aimed to evaluate Guduchi Ghana Vati as a preventive remedy for COVID-19 and non-COVID-19 infections in a healthy population. Materials and methods An open-labeled, multi-centric, randomized, comparative, interventional, prospective community-based clinical study was conducted on healthy individuals at the community level in five different districts of Rajasthan by the National Institute of Ayurveda (NIA), Jaipur, India. Participants were divided into two groups. One group received Guduchi Ghana Vati as an intervention for 45 days, and the control group did not receive any intervention. Incidences of COVID-19 infection, non-COVID-19 infections, their severity, and hospitalization requirements were assessed. Safety was evaluated through monitoring of adverse reactions. Results Among the 10,022 participants who completed the study, the incidence of COVID-19 infection was found to be lower in those taking Guduchi Ghana Vati compared to the control group; however, the difference was statistically non-significant. The severity of COVID-19 based on the WHO ordinal scale was found to be significantly lower in the Guduchi Ghana Vati group compared to the control group. The number of episodes and severity of non-COVID-19 illness were also significantly lower in participants taking Guduchi Ghana Vati compared to the control group. No major adverse drug reactions were observed. Conclusion Guduchi Ghana Vati has the potential to act as a safe and effective remedy for the prevention of infection and immunity-related conditions, including COVID-19.

Randomized, Double-Blind, Placebo-Controlled, Clinical Study of Passiflora incarnata in Participants With Stress and Sleep Problems.

Background and objectives SIVI is a standardized extract prepared using the aerial parts of Passiflora incarnata developed to enhance the quality of sleep. ​​​​​​The objective of the present study was to the evaluate efficacy and safety of SIVI (Passiflora incarnata extract) in the management of stress and sleep problems in Indian participants in a randomized, double-blind, placebo-controlled, clinical study. Materials and methods A total of 65 participants with stress and insomnia were randomized to two groups with 32 in the SIVI (Passiflora incarnata extract) group and 33 in the placebo group. Subjects were asked to take the test substance along with water at bedtime for 30 days. The Perceived Stress Scale, quality of life using the General Health Questionnaire (GHQ-12) scale, and Insomnia Severity Index were assessed on day 1, day 15, and day 30. Results Passiflora incarnata extract showed a statistically significant reduction in the mean score of stress on the Perceived Stress Scale and significantly increased the mean score of total sleep time compared to placebo. The general psychological health was found to be significantly improved in the SIVI (Passiflora incarnata extract) group compared to the placebo group on day 15 and day 30. SIVI (Passiflora incarnata extract) did not show any adverse effects. Conclusions The results of the current study indicate that Passiflora incarnata extract is beneficial in the management of stress and helps to improve sleep quality in subjects with stress and insomnia.

Virgin Coconut Oil Alleviates Dextran Sulphate-Induced Inflammatory Bowel Disease and Modulates Inflammation and Immune Response in Mice.

OBJECTIVE: Virgin coconut oil (VCNO), an unrefined kernel oil from Cocos nucifera L., has considerable medicinal and nutritive value. Experimental evidence suggests its antioxidant, anti-inflammatory, chemoprotective, analgesic, and hypolipidemic effects. Presently, the effect of VCNO on ameliorating dextran sodium sulfate (DSS)-induced inflammatory bowel disease and cyclophosphamide (CTX)-induced immunosuppression in experimental animals was analyzed. METHOD: DSS (4%) was administered to BALB/c mice through drinking water for 12 days to induce inflammatory bowel disease, and VCNO (500, 750, and 1000 mg/kg bwt) was supplemented orally for 12 days. For anti-inflammatory studies, lipopolysaccharide (LPS, 250 µg/animal) was injected into the intraperitoneal cavity of Swiss albino mice followed by 7 days' pretreatment of VCNO (500, 750, and 1000 mg/kg bwt). To understand the mechanism of action, serum from all animals was collected after 6 hours of LPS challenge and levels of proinflammatory cytokines were analyzed using enzyme-inked immunosorbent assay. In addition to this, immunosuppression was induced by CTX (50 mg/kg bwt, po) in Swiss albino mice. RESULTS: Oral administration of VCNO effectively reversed the pathologies associated with inflammatory bowel disease induced by DSS, including loss of body weight, increased disease activity index, shortening of colon length, diarrhea, and rectal bleeding. Histopathological examination showed that VCNO restored the damage in colon tissue induced by DSS. Similar trends were noticed in levels of myeloperoxidase and mRNA expression of proinflammatory cytokines in colon tissue. In addition to this, supplementation of VCNO markedly reduced the hike in the level of serum proinflammatory cytokines in LPS-challenged mice. Further, administration of VCNO effectively increased spleen and thymus indexes and stimulated the production of interferon-γ in serum. CONCLUSIONS: Overall, this study revealed that VCNO alleviates inflammatory bowel disease and inflammation; concurrently, it can revert immunosuppression.

Comparative effect of composite management of type II diabetes mellitus with induced emesis and Varadi Ghanavati: A pilot clinical study.

INTRODUCTION: Ayurveda offers a rational view in the management of Prameha. Shodhana (∼bio-purification) is advocated as the first line of treatment to eliminate Kapha, which is followed by palliative treatment to further control disease pathology. Evaluation of such composite treatment has rarely been published. The present study was conducted to assess the comparative efficacy and safety of three interventions in the management of Prameha (Diabetes mellitus type II (T2DM)) - (a) Vamana (induced emesis) and Varadi Ghanavati (oral Ayurvedic medication), (b) Varadi Ghanavati, and (c) glibenclamide. METHODS: It was open labelled, comparative, randomised, prospective, three arm pilot study. A total 49 patients, newly diagnosed or known cases of Prameha (T2DM) were randomised in three groups. The first group (Vamana) received Vamana followed by Varadi Ghanavati (500 mg (mg) thrice daily before food for 12 weeks). The second (Varadi) group received Varadi Ghanavati without prior Vamana, while, the control group received glibenclamide 5 mg twice daily before food for 12 weeks. Patients were evaluated at intervals of each four weeks. Assessment was done on changes seen in blood sugar (BSL) fasting (F), postprandial (PP), glycosylated haemoglobin, lipid profile, body mass index (BMI) and clinical symptoms. RESULTS: Patients in all groups showed better glycaemic control as compared to baseline. Mean BSLF before and after treatment were 166.20 ± 78.39 mg/dL and 125.00 ± 58.77 mg/dL in Vamana group (p < 0.01), 163.60 ± 59.34 mg/dL and 127.73 ± 37.94 mg/dL in Varadi group (p < 0.05), while 163.00 ± 59.03 mg/dL and 129.40 ± 41.91 mg/dL in control (p < 0.05). Similarly, BSL PP values before and after treatment were 254.47 ± 99.59 mg/dL and 178.47 ± 68.45 mg/dL in Vamana group (p < 0.01), 233.93 ± 68.95 mg/dL and 185.20 ± 56.73 mg/dL in Varadi group (p < 0.05), 239.80 ± 77.10 mg/dL and 182.53 ± 42.14 mg/dL in control (p < 0.05). Glycosylated haemoglobin, mean values before and after treatment were 8.23 ± 1.71% and 7.18 ± 1.96% in Vamana group (p < 0.05), 7.83 ± 1.21% and 6.75 ± 1.13% in Varadi group (p < 0.05), 7.17 ± 1.12% and 6.60 ± 0.65% in glibenclamide group (p < 0.05). Comparative evaluation in the three groups showed that there was a statistically significant reduction (p < 0.001) in total cholesterol, low-density lipoproteins (LDL) and BMI in Vamana group as compared the other groups. No adverse event was observed. CONCLUSION: Along with better glycaemic control, composite treatment can reduce deranged lipids and BMI, which can help in better management of Prameha (T2DM). Vamana and Varadi Ghanavati can be administered safely. CLINICAL TRIAL REGISTRATION NO: CTRI/2017/10/010127.

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.

Wound healing activity of topical herbal aerosol sprays on diabetic and Varicose Ulcers: A randomized, controlled, open labelled, multi-centric clinical trial.

BACKGROUND: Panchavalkala Kwatha and Jatyadi Taila are recommended for cleaning and healing of non-healing ulcers such as Diabetic Foot Ulcer (DFU) and Varicose Ulcers (VU). OBJECTIVES: Innovative topical aerosol sprays viz. Panchavalkala Kwatha Aerosol Spray (PKS) and Jatyadi Taila (Healz) Aerosol Spray (JTS) were evaluated for healing in DFU & VU against conventional treatment. MATERIALS & METHODS: After obtaining approval from Ethics Commitees & informed consent, 53 patients were randomized in two study groups. In one group, ulcer cleaning was done with PKS and then JTS was used for dressing while in other group, cleaning was done with Hydrogen peroxide and/or Hypochlorite followed by dressing with 10% Povidone iodine. Ulcer examination was done from baseline to every 7th day by Bates Jensen ulcer assessment tool, digital photographs and photographic ulcer assessment tool. Comparison of categorical variables was done using t-test. RESULTS: The dual action of PKS and JTS exhibited potentially comparable effect to the conventional treatment. CONCLUSION: PKS and JTS were found to be effective, comfortable, hygenic and acceptable in management of chronic ulcers.

Effect of Airborne Low Intensity Multi frequency ultrasound (ALIMFUS) on glycemic control, lipid profile and markers of inflammation in patients with uncontrolled type 2 diabetes: A multicentre proof of concept, randomized double blind Placebo controlled study.

BACKGROUND AND AIMS: Airborne Low Intensity Multi frequency Ultrasound (ALIMFUS) uses thermal and non thermal principal of ultrasound to facilitate transportation of drugs into the cells and it's metabolism. This is randomized, multi-center, Double Blind, Interventional, Placebo Controlled Study to evaluate efficacy and safety of ALIMFUS as an Add-on therapy to Oral Hypoglycemic Agent (OHA) in Type 2 DM. METHODS: Total 103/186 subjects completed the study and received 10 min either ALIMFUS therapy on alternate day for 90 days or placebo. Baseline and end of the study Lab parameters like HbA1c, blood sugars, Lipid Profile, Serum Hs-CRP, Serum Interleukin-6, Serum TNF-α, Serum homocysteine, Serum Vitamin D, Serum Leptin, Serum Adiponectin and Quality of Life score were assessed. RESULTS: At the end of study ALIMFUS group achieved greater (0.77 ± 1.13 vs 0.48 ± 0.79) but non-significant reduction in HbA1c. More subjects in ALIMFUS group (30.76% vs 27.45%) achieved HbA1c < 7%. Significant reduction in fasting and postprandial glucose noted in both groups whose baseline HbA1c was ≥8%. Significant reduction in lipid profile noted in ALIMFUS group compared to placebo. Insulin, adiponectin, CRP and homocysteine and quality of life were significantly better in ALMFUS group compared to baseline; but non-significant compared to placebo. No adverse events were associated with ALIMFUS. CONCLUSIONS: Thus, ALIMFUS could be novel technology in diabetes management for patient unable to achieve glycemic targets on combination therapy. However further exploratory long term studies are required to demonstrate its effective role as add-on therapy in diabetes management.

Prospective, Randomized, Open-Label, Blinded End Point, Two-Arm, Comparative Clinical Study to Evaluate the Efficacy and Safety of a Fixed Ayurvedic Regimen (FAR) as Add-on to Conventional Treatment in the Management of Mild and Moderate COVID-19 Patients.

BACKGROUND: The traditional healthcare systems are being avidly looked into in the quest for effective remedies to tackle the menace of COVID-19 pandemic. OBJECTIVE: This was a prospective randomized, controlled open-label, blinded end point (PROBE) study to evaluate the efficacy and safety of a fixed ayurvedic regimen (FAR) as an add-on to conventional treatment/standard of care (SOC) in the management of mild-to-moderate COVID-19 infection. METHODOLOGY: A total of 68 patients were recruited who consumed either FAR + SOC (n = 35) or SOC only (n = 33) for 28 days. Primary outcomes assessed were mean time required for clinical recovery and proportion of patients showing clinical recovery between the groups. Secondary outcomes assessed included mean time required for testing SARS-CoV-2 negative, change in clinical status on World Health Organization (WHO) ordinal scale, number of days of hospitalization, change in disease progression and requirement of oxygen/intensive care unit admission/ventilator support/rescue medication, health status on WHO quality of life (QOL) BREF and safety on the basis of occurrence of adverse event/serious adverse event (AE/SAE) and changes in laboratory parameters. RESULTS: Patients consuming FAR as an add-on SOC showed faster clinical recovery from the day of onset of symptoms by 51.34% (P < 0.05) as compared to SOC group. A higher proportion of patients taking FAR recovered within the first 2 weeks compared to those taking only SOC. It was observed that 5 times more patients recovered within 7 days in FAR group when compared to SOC (P < 0.05) group. An earlier clinical recovery was observed in clinical symptoms such as sore throat, cough, loss of taste and myalgia (P < 0.05). Improvement in postclinical symptoms such as appetite, digestion, stress and anxiety was also obs served to be better with the use of FAR. Requirement of rescue medications such as antipyretics, analgesics and antibiotics was also found to be reduced in the FAR group (P < 0.05). FAR showed a significant improvement in all the assessed domains of QOL. None of the AEs/SAE reported in the study were assessed to be related to the study drugs. Further, FAR did not produce any significant change in the laboratory safety parameters and was assessed to be safe. CONCLUSION: FAR could be an effective and safe add-on ayurvedic regimen to standard of care in the management of mild and moderate COVID-19 patients. CTRI number: CTRI/2020/09/027914.

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).