A Randomized, Multi Center, Double Blinded, Placebo-Controlled, Parallel-Group, Comparative Clinical Study to Evaluate the Safety and Efficacy of BCO-5 on Sleep Quality and ImmunomodulatorySupport in Healthy Subjects with Sleep Deprivation.

Akay Natural Ingredients Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1.PSQI score greater than 5
•2. Perceived Stress Scale greater than 14
•3. Generally healthy subjects with body weight greater than 50kg.
•4. Women of child bearing potential practicing an acceptable method of birth control as judged by the investigator(s) [such as condoms, foams, jellies, diaphragm, intrauterine device, oral or long acting injected contraceptives].
•5. Should be ready to abstain from alcohol consumption, smoking and consumption of caffeinated beverages.
•6. Must be willing and able to give informed consent and comply with the study procedures

•1. Subjects suffering from any chronic health conditions (e.g. diabetes, hypertension, chronic renal
•failure, heart, thyroid and liver disease) requiring medical treatment
•2. Hepatic impairment (Alanine transaminase/Aspartate transaminase levels less than 3 upper limit of normal) or renal impairment (serum creatinine less than 2.0 mg/dl)
•3.History of Chronic metabolic disease, Psychiatric illness, Drug abuse, smoking, abuse/addiction to alcohol, Endocrine abnormalities including stable thyroid disease Cardiovascular surgery / History of any major surgery
•4. Subjects having symptoms of viral infection, including COVID-19 infection
•5. Known HIV or Hepatitis B positive or any other immuno-compromised state
•6. Pregnant and lactating women
•7. Subjects allergic to Herbal Nutra or Pharmaceutical products
•8. Currently participating or having participated in another clinical trial during the last 1 month prior to the beginning of this study
•9. Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.

发起方

Akay Natural Ingredients Pvt Ltd