A Clinical Study toEvaluate the Efficacy and Safety of Ashwagandha Extract Formulation on Improvement of Energy and Endurance in Adults

Completed

Brief Summary: This is a Randomized, Double Blind, Placebo Controlled Clinical Study to Evaluate the Efficacy and Safety of Ashwagandha Extract Formulation (ASVAMANÂ®) on Improvement of Energy and Endurance in Adults

Recruitment & Eligibility

Inclusion Criteria

Male healthy adult subjects ranging in age from 18 to 50 years.
Willingness to follow the protocol requirements as evidenced by written, informed consent.
Mentally, physically and legally eligible to give informed consent 4.
Male subjects BMI between 20.0 â€“ 25.9 kg/m2 5.
Willingness to complete study questionnaires.

Exclusion Criteria

Patients with pre-existing severe systemic disease necessitating long-term medication.
Significant medical or psychiatric illness 3.
History of cancer, including solid tumors, hematologic malignancies and carcinoma in situ 4.
Any neurological (congenital or acquired), vascular or systemic disorder which could affect any of the efficacy assessments 5.
Participation in the current or previous treatment with any approved or investigational health supplement(s) during the past 1 month.
Subjects received other medication (anti-viral) within the 36 hours before entry into the study 7.
Patients who had immunization against influenza or influenza like illnesses for that season.
Inability to comply with the study protocol, including psychiatric diseases.
Immune compromised or with other clinically active illness including cardiac or pulmonary diseases, hemoglobinopathies, renal dysfunction 10.
Having vaccination of a seasonal or new influenza A (H1N1) vaccine 6 months before.
Other reasons that researchers think not fitting to participate in the study 12.
Evidence of significant uncontrolled comorbid disease which in the investigators opinion would jeopardize patient participation.
Patient tested positive with Covid 19.

Primary Outcome Measures

Name	Time	Method
Change from baseline to the end of the study period in Serum Cortisol	Day 0 and Day 42

Secondary Outcome Measures

Name	Time	Method
Change from baseline to the end of the study period in One Leg Stand Test	Day 0, Day 21 and Day 42
Change from baseline to the end of the study period in Testosterone	Day 0 and Day 42
Change from baseline to the end of the study period in Six Minutesâ€™ walk test	Day 0, Day 21 and Day 42
Change from baseline to the end of the study period in Stair Climb Test	Day 0, Day 21 and Day 42
Change from baseline to the end of the study period in 30 Meter walk test	Day 0, Day 21 and Day 42
Change from baseline to the end of the study period in Chair Stand Test	Day 0, Day 21 and Day 42
Change from baseline to the end of the study period in Quality of Life â€“ SF 36	Day 0, Day 21 and Day 42

Locations (1): Vatsalya Hospital
🇮🇳
Varanasi, UTTAR PRADESH, India
Vatsalya Hospital
🇮🇳Varanasi, UTTAR PRADESH, India
Dr Gaurav Singh
Principal investigator
gaurav@gmail.com