Clinical study on Sleep Rhythm Capsules in sleep disturbance

Phase 2

• Registration Number: CTRI/2024/07/070841
• Lead Sponsor: Transformative Learning Solutions Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

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

Inclusion Criteria

1. Participants aged greater than or equal to 21 and less than 65 years at the time of obtaining written informed consent

2. Participants with score between 7-21 on ISI (Insomnia severity index)

3. Participants willing to sign inform consent form and ready to follow the study protocol requirements

4. A female participant who is of reproductive potential has a negative pregnancy test and agrees to use contraception throughout study period

Exclusion Criteria

1. Participants with history or diagnosis of secondary sleep disorder (any other underlying medical or surgical condition diagnosed on the basis of history and clinical examination by the investigator)

2. Participants with history of any neurological disorder causing interference in sleep

3. Participants with history of bipolar disorder, psychotic disorder, or posttraumatic stress disorder, or current psychiatric disorder that requires medication

4. Participants with On-going depression & generalized anxiety disorder

5. Participants with history of drug or alcohol addiction or abuse within the past 12 months

6. Participants with habit of smoking Cigarette (Average of more than 5 cigarettes per day over the last 5 years)

7. Participants with known history of hepatitis B and or C

8. Participants with history of malignancy less than or equal to 5 years prior to study participation

9. Participants with shift work disorders and other psychiatric disorders which need medication

10. Participants with known hypersensitivity to any of the ingredients of study products

11. Participants with other conditions, which in the opinion of the investigators, makes the participant unsuitable for enrolment or could interfere with his/her participation in, and completion of the protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified