A Randomized, Double blind, Placebo controlled, Multi-centric, Interventional, Prospective Clinical study to Evaluate Efficacy and Safety of Passiflora incarnata (Aerial Parts) Extract in participants with Stress and Insomnia

JK Botanicals Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年7月25日

试验速览

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•1.Literate subjects who perceive themselves to be under stress and having a score of between 14 - 24 on the Perceived Stress Scale (PSS)
•2.Subjects with insomnia severity more than 7 and equal to 21 on insomnia severity index
•3.Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.

•1.Subjects suffering from any known chronic physical, hormonal or psychiatric illness
•2. Subjects using oral or systemic contraceptive medications
•3. Subjects with uncontrolled diabetes and hypertension
•4. Subjects with substance dependence
•5. Chronic alcoholics and Habitual Tobacco chewers.
•6. Known cases of severe or chronic hepatic or renal disease.
•7.Known case of any active malignancy.
•8. Subjects giving history of significant cardiovascular event less than12 weeks prior to recruitment.
•9. Subjects having known chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
•10. Known cases of active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes.
•11. Subjects using any other investigational drug within 1 month prior to recruitment or subjects currently participating in any other Clinical study
•12. Known hypersensitivity to any of the ingredients used in study products
•13. Pregnant and Lactating females.
•14. Other conditions, which in the opinion of the investigators, make Subject unsuitable for enrolment or could interfere with his/her participation in, and completion of the study

发起方

JK Botanicals Private Limited