To evaluate safety and efficacy of a botanical containing tablet (CAG-11) in the management of Stress

Phase 3

• Conditions: Health Condition 1: F488- Other specified nonpsychotic mental disorders

• Registration Number: CTRI/2023/10/058467
• Lead Sponsor: Amway Global Services India Pvt. Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Men and women aged between 18-50 years, both inclusive.

2. Subjects presenting continuous stress related problems for more than 2 weeks

3. Subjects not under treatment for stress in the last 2 weeks of screening

4. Subjects presenting moderate continuous stress levels basis PSS scale between 14 - 26

5. Able and willing to follow all study related instructions.

6. Must be willing to give written informed consent and comply with the study procedures.

7. Subject’s complete blood count parameters to be within clinically acceptable range by Investigator.

Exclusion Criteria

1. Pregnant and Breast-feeding women will be excluded.

2. On-going treatment on managing stress levels.

3. Severe psychiatric disorders, severe episodes of anxiety disorders, post-traumatic stress disorder

4. Subjects presenting with severe continuous stress levels basis PSS scale (27 – 40)

5. Systemic disorders, who have undergone surgeries, are on medications, endocrinal disorders

6. History of having received any investigational drug or participated in any other clinical trial which ended in the preceding three months

7. Any condition that in the opinion of the investigator does not justify the subject’s inclusion for the study.

8. Subjects with underlying heart conditions, other lifestyle disorders and systemic illness.

Study & Design

• Study Type: Interventional
• Study Design: Not specified