None listed
Conditions
Interventions
Intervention1: Withania somnifera extract capsule: 500 mg capsule twice a day, after breakfast and after dinner
for 30 days.
Control Intervention1: Nil: Nil
Sponsors
Pharmanza Herbal Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male subjects having age between 18 to 60 years (both inclusive) 2. BMI between 18.5 and 24.9 kg/m2 (both inclusive) 3. Apparently mentally and physically healthy and biochemical parameters within normal reference ranges 4. Willingness to complete the study interventions and follow-up 5. Subjects with normal cardiovascular function with no evidence of acute ischemic heart disease in the electrocardiogram 6. The subject willing to provide consent and visit on follow up and abide protocol related requirements.
Exclusion criteria
Exclusion criteria: 1. Being on a medically prescribed drug or supplements 2. Reported weight loss/gain >10% of body weight in the 6-month preceding pre-study examination 3. Using herbal supplements or dietary supplements meant for improving health and wellbeing 4. History of hypersensitivity to Ashwagandha 5. Undergoing medical treatment that may interfere with the study outcome 6. Consuming alcohol, smoking and/ or chewing tobacco during the past 6 months 7. Recreational drug use during the past 6 months 8. Subjects with diagnosis of an active disease and/or receiving pharmacological treatment prescribed for an active disease and who have evidence of an active disease at the time of the initial clinical examination at the discretion of the investigator 9. Any other major clinical disease or psychiatric disorder that, at the discretion of the investigator, precludes the administration or completion of the protocol treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Clinical laboratory examination of complete blood count (CBC), lipid profile, thyroid profile, liver function test (LFT), kidney function test (KFT), urine analysis, serum B12 levels, and CRP from screening to end of the study. 2. Observations in x-ray and ECG from screening to end of the study. 3. Vital signs from screening to end of the study.Timepoint: Screening visit, Baseline, Visit 2(Day 15), Visit 3(Day 31) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cardiorespiratory endurance by step test at screening and end of the study. 2. Body fat percentage and lean body weight by measuring skinfold thickness at four areas such as biceps, triceps, subscapular, and suprailiac with a Skin Fold Caliper in millimeters at screening and end of the study. 3. Adverse events profile from baseline to end of the study. 4. Tolerability of the investigational product from baseline to end of the study.Timepoint: Screening visit, Baseline, Visit 2(Day 15), Visit 3(Day 31) | — |
Countries
India
Contacts
Public ContactDr Siddharth J Modi
Pharmanza Herbal Pvt. Ltd.
Outcome results
None listed