Efficacy And Safety of KSM66 Ashwagandha (Withania somnifera) standardized root extract (300 mg) on Weight and Stress Management in overweight and obese Adults: A Prospective, Randomized, Double-Blind Placebo Controlled Study

Shri Kartikeya Pharma Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年5月1日

试验速览

暂无简介。

•1. Healthy adult men and women participants >= 19 years and <=65 years of age.
•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

•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.

发起方

Shri Kartikeya Pharma Pvt Ltd