None listed
Conditions
Interventions
Intervention1: Tablet Withania Somnifera: One tablet 250 mg twice a day for two months
Control Intervention1: Tablet placebo: One tablet 250 mg twice a day for two months
Sponsors
NIL
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female, 18 to 30 years 2. Volunteers with normal health status which will be assessed by below mentioned investigations. 1) Clinical history and physical examination 2) Hematological: Hb, CBC within 10% of the normal range detected at screening 3) Biochemical: Serum SGOT, SGPT & Serum BUN and Serum Creatinine, FBS, S.LDL, S. Cholesterol, S. Triglycerides within 1.5 times upper limit of normal range detected at screening. 3. Volunteers ready to refrain from unaccustomed strenuous physical activity and follow constant diet pattern at least one week before starting the study & throughout the study duration & those who do not drink & smoke (at least for past six months) 4. Volunteers with no h/o any lower limb or upper limb injury within past six months or co-morbid condition, underwent surgical procedure wherein exercise is contraindicated. 5. Volunteers ready to abide by trial procedures and to give a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Volunteers with h/o of allergy or intolerance to herbal drugs or anaphylactic reaction 2. Volunteers with h/o intake of traditional systems of medicine including drugs with Rasayana properties in the past 4 weeks. 3. Volunteers with BMI less than 23 or more than 30. 4. Pregnant and lactating woman. 5. Volunteers taking anabolic steroids, protein supplements or other nutritional supplements, vitamins, anti oxidants for more than 5 days on contionous basis and use of any recreational drug or a history of drug addiction. 6. Volunteers with known cardiovascular, musculoskeletal, hepatobiliary, genitourinary, neurological or any psychiatric condition. 7. Volunteers on any chronic medication ( > 2weeks in the last six months) 8. Volunteers who have recently joined gymnasium in past one month and are doing active resistance exercises. 9. Volunteer participating in another investigational drug trial in the previous 30 days. 10. Volunteers who cannot give valid consent such as mentally retarded or with psychiatric illness. 11. Volunteers with documented h/o positive screening result for hepatitis B and/or hepatitis C virus and documented h/o HIV or any immune deficient conditions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Statistical significant change in level of biomarkers of muscle status and inflammation in response to exercise (based on serum CPK, serum LDH, serum myostatin, IL-6, hs-CRP, TNF - α) in volunteers administered Withania somnifera.Timepoint: On day (-3) and day 60. | — |
Secondary
| Measure | Time frame |
|---|---|
| No statistical significant change in haematological parameters (Hb, CBC, FBS, S. LDL, S. Cholesterol, S. Triglycerides, SGOT, SGPT, BUN, S. Creatinine) in volunteers administered placeboTimepoint: on day 1 and day 60.;No statistical significant change in haematological parameters (Hb, CBC, FBS, S. LDL, S. Cholesterol, S. Triglycerides, SGOT, SGPT, BUN, S. Creatinine) in volunteers administered Withania somniferaTimepoint: on day 1 and day 60.;No statistical significant change in haematological parameters (Hb, CBC, FBS, S. LDL, S. Cholesterol, S. Triglycerides,SGOT, SGPT, BUN, S. Creatinine) in volunteers administered Withania somnifera in comparison to placeboTimepoint: on day 1 and day 60.;No Statistical significant change in in body composition of volunteers administered placebo (based on body muscle mass, body fat mass, body weight) in response to exerciseTimepoint: on day 1, day 15, day 30, day 45 and day 60.;No statistical significant change in level biomarkers of muscle status and inflammation in response to exercise (based on serum CPK, serum LDH, serum myostatin, IL-6, hs-CRP, TNF - α) in volunteers administered placeboTimepoint: day (-3), day 1, day 30 and day 60.;No statistical significant change in physical performance of volunteers administered placebo (based on distance travelled in kms on bicycle ergometer, hand grip strength, leg press dynamometer) in response to exerciseTimepoint: on day 1, day 15, day 30, day 45 and day 60.;Number of volunteers with clinical adverse events administered Withania sominfera in comparison to those administered placeboTimepoint: Day 60;Statistical significant change in body composition in volunteers administered Withania Somnifera in comparison to placebo (based on body muscle mass, body fat mass, body weight) in response to exerciseTimepoint: on day 1 and day 60.;Statistical significant change in in body composition of volunteers administered Withania somnifera (based on body muscle mass, body fat mass, body weight) in | — |
Countries
India
Contacts
Public ContactDr Padmaja Marathe
Seth GS Medical College & KEM Hospital
Outcome results
None listed