The Effect of Ocitum™ (Tulsi Leaf Extract) on Depression, Anxiety, Stress, and Sleep Quality.

Phase 2

• Conditions: Health Condition 1: F411- Generalized anxiety disorder

• Registration Number: CTRI/2024/03/063413
• Lead Sponsor: K Patel Phytoextractions Pvt Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Able to provide written informed consent.

2. Able and willing to comply with the protocol, including availability for all scheduled study visits.

3. Male and female aged between 18 and 65 years (both inclusive), as of the screening date.

4. Individuals experiencing stress for longer than a month, and currently experiencing insomnia/sleep problems (either difficulty falling asleep, staying asleep, or unrefreshing sleep).

5. Participants are required to score minimum 10-20 on Depression, 8-14 on anxiety & 15-25 on stress on DASS-21.

6. No history of addiction to any recreational drug or drug dependence.

7. Subjects who are non-alcoholic and non-smokers.

8. Subjects with no ongoing pre-existing medical conditions.

9. Subjects not currently taking medicines or supplements for stress, anxiety or sleep disturbance.

Exclusion Criteria

1.

Participants will not be eligible if they have a serious psychiatric disorder or certain medical conditions, such as diabetes, high or low blood pressure, heart disease, or gastrointestinal issues.

2.

Participants requiring regular use of medications for gallbladder disease, autoimmune disease, endocrine disease, or acute or chronic pain conditions.

3.

Females who are pregnant or planning pregnancy, lactating, or taking any oral contraceptives.

4.

Individuals consuming more than 4 cups of coffee (or equivalent caffeine levels from other sources) or taking herbal or vitamin supplements that are anticipated to significantly influence study outcomes.

Study & Design

• Study Type: Interventional
• Study Design: Not specified