A clinical study to evaluate the effect of BCO-5 on safety ,sleep, stress and immunity in Healthy Subjects with Sleep Deprivatio

Not Applicable

Registration Number: CTRI/2021/05/033780

Lead Sponsor: Akay Natural Ingredients Pvt Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Safety of BCO-5Timepoint: Day 0, Day 45, Day 90

Secondary Outcome Measures

Name	Time	Method
Changes in Bio MarkersTimepoint: Day 45, Day 90;Changes In Questionnaire based assessmentsTimepoint: Day 0, Day 45, Day 90;Changes in Stress levelTimepoint: Day 0, Day 45, Day 90