None listed
Conditions
Interventions
Intervention1: KSM66 ashwagandha: The test formulation contains powdered Ashwagandha 300 mg filled in hard gelatin capsules which will be administered orally (b.i.d.) one capsule in the morning and on
Sponsors
SKP Labs Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy athletic adults of male and female subjects aged between 20 and 45 years. 2. Subjects within the BMI range of 18.5 to 24.9 kg/m2 3. Subjects able to communicate effectively 4. Subjects willing to provide written informed consent 5. In the judgment of the Principal Investigator, able to comply with protocol requirements
Exclusion criteria
Exclusion criteria: 1 Contraindications or Hypersensitivity to ashwagandha and related herbal products. 2 History or presence of any medical condition or disease according to the discretion of the Investigator. 3 History of significant renal or hepatic problems. 4 History of significant asthma, urticaria or other allergic reactions 5 History of severe GI disorders such as mal-absorption syndrome. 6 History of diabetes, coronary artery disease and hypertension with or without complication 7 History of any chronic physical, hormonal or psychiatric illness 8 Morbid Obesity (percent fat 40% 9 Any medical condition where exercise is contraindicated 10 Recent surgery or trauma which incapacitates the subject for exercise. 11 Currently taking any herbal preparations (other formulations containing ashwagandha / ginseng / ginkgo biloba / brahmi etc). 12 Current substance dependence 13 Individuals refusing to use appropriate non-hormonal birth control measures. 14 Subjects participating in any other trial. 15 Female subjects found positive in urine pregnancy test. 16 Female subjects who are under breast feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in the 20M shuttle run test score from Visit 0 to after Day 56 (Visit 2) and Day 84 (Visit 3) of treatment.Timepoint: day 0, day 28, day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety will be assessed from the number of adverse events occurred and judging their causal relationship to the study drug. â?? The change in the Borg scale score, after Visit 0 to after Day 56 (Visit 2) and Day 84 (Visit 3) of treatment. â?? Quality of life (QOL) of improvement.Timepoint: day 0 day 28, day 56, day 84 | — |
Countries
India
Contacts
Public ContactDr Sanchita Das
MakroCare Clinical Research Limited
Outcome results
None listed