None listed
Conditions
Interventions
Intervention1: KSM-66 capsules containing
Ashwagandha 500 mg
standardized root extract: Standardized root extract 500
mg two capsules to be taken two times a day orally with water/milk for a period of
Sponsors
D Y Patil Medical College Nerul
Eligibility
Inclusion criteria
Inclusion criteria: 1 Both Adults (male and female) aged between 18 and 65years 2 Participate should be healthy and free from any chronic illness, such as diabetic, cardiovascular or any other condition that could affect the safety of the study 3 No plan to commence any other alternative treatment modality for their conditions 4 Willingness to sign an informed consent document and to comply with all study related procedures
Exclusion criteria
Exclusion criteria: 1 History of Alcohol or smoking abuse. 2 History of hypersensitivity to Ashwagandha. 3 Taking nutritional or energy supplements, medication, or steroids, 4 Any history of drug abuse. 5 Having any clinical abnormalities. 6 Simultaneously participating in any other clinical trial or participated in the past three months. 7 Participants who use medication for blood pressure, use beta-blockers, inhaled any beta-agonists, use any hormonal contraceptives, having a history of corticosteroid use within three months, participants under psychotropic medication within last 8 weeks, and 8 Participants diagnosed with any heart disease, diabetes, stroke, neurological disorders or depression. 9 Have clinically significant acute unstable hepatic, renal, cardiovascular, or respiratory disease that will prevent participation in the study. 10 Patients with depressive episode, panic disorder, social phobia, obsessive-compulsory disorder, alcohol dependency; schizophrenia and mania. 11 Patients with post traumatic disorder. 12 Have an established practice of meditation for three or more months. 13 Pregnant and lactating women. 14 Participation in other clinical trials during previous 3 months 15 Any clinical condition, according to the investigator which does not allow safe fulfilment of clinical trial protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Blood Count, Renal Function Test, Liver Function Test, Lipid Profile and Thyroid Function Test, Fasting blood sugar and HbA1c TestTimepoint: Baseline, Weeks 4, Weeks 8, Weeks 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes from baseline in the Quality of Life (SF-36 QoL)Timepoint: Baseline, Weeks 4, Weeks 8, Weeks 12;Number and proportion of Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Event (TESAE)Timepoint: Baseline, Weeks 4, Weeks 8, Weeks 12 | — |
Countries
India
Contacts
Public ContactDr Deepak Langade
D Y Patil Medical College
Outcome results
None listed