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.

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.

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.

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).