Health Condition 1: E663- Overweight
Conditions
Interventions
Intervention1: KSM-66 capsules containing
Ashwagandha 300 mg
standardized root extract: Standardized root extract 300
mg to be taken two times in a
day orally with water/milk for
period of 24 weeks
Co
Sponsors
Shri Kartikeya Pharma Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy adult men and women participants >= 19 years and 2. Willingness to follow the protocol requirements as evidenced by written informed consent. 3. Participants willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements. 4. Participants who agree to take investigational product (i.e., Till Week 8). 5. Participants with Body mass index between 25 and 39.9 kg/m2
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. 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 |
|---|---|
| Reduction in body weight and Body Mass Index (BMI)Timepoint: Baseline, Week 4, Week 12, Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete Blood Count, Renal Function Test, Liver Function Test, Lipid Profile, Thyroid Function Test, Fasting Blood Sugar and Hba1c TestTimepoint: Baseline, Week 4, Week 12, Week 24;Food Cravings Questionnaireâ??Trait (FCQâ??T)Timepoint: Baseline, Week 4, Week 12, Week 24;Perceived Stress Scale (PSS-10)Timepoint: Baseline, Week 4, Week 12, Week 24;Quality of Life (SF-12 QoL)Timepoint: Baseline, Week 4, Week 12, Week 24;Standard Stress Scale (SSS)Timepoint: Baseline, Week 4, Week 12, Week 24 | — |
Countries
India
Contacts
Public ContactDr Ketan Phakale
A Metabolic Syndrome Clinic
Outcome results
None listed