CTRI/2024/02/063267招募中2 期
A Randomized, Double Blind, Comparative, Multi-centric, Interventional, Prospective, Clinical study to Evaluate Efficacy & Safety of Topical head application Oil in participants with Stress & Insomnia - NI
试验速览
- 阶段
- 2 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Participants who perceive themselves to be under stress and having a score of between 14 - 24 on the Perceived Stress Scale (PSS)
- •2. Participants with insomnia severity more than 7 and less than or equal to 21 on insomnia severity index
- •3. Participants willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.
排除标准
- •1. Participants currently suffering from any known chronic physical, hormonal or psychiatric illness
- •2. Participants with uncontrolled diabetes and hypertension
- •3. Participants with substance dependence e.g. taking prohibited medications such as opium, cannabis (marijuana) and methamphetamines etc.
- •4. Chronic alcoholics and Habitual Tobacco chewers.
- •6. Known cases of severe/chronic hepatic or renal disease.
- •7. Known case of any active malignancy.
- •8. Participants with history of cardiovascular event less than 12 weeks prior to recruitment.
- •9. Participants having known chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
- •10. Participants using any other investigational drug within 1 month prior to recruitment or participants currently participating in any other Clinical study
- •11. Known hypersensitivity to any of the ingredients used in study products
- •12. Participants with any current skin or scalp related medical or surgical condition
- •13. Pregnant and Lactating females.
- •14. Other conditions, which in the opinion of the investigators, make participant unsuitable for enrolment or could interfere with his/her participation and completion of the study
研究者
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