A clinical trial to study the effects of Sleep/ Wellâ?? capsules in patients having difficulty in sleeping

Not Applicable

Completed

• Conditions: Health Condition 1: F510- Insomnia not due to a substance orknown physiological condition

• Registration Number: CTRI/2022/11/047323
• Lead Sponsor: MOOM HEALTH PTE LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-01-02
• Last Update Posted: 6 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 96

Inclusion Criteria

1. Female participants with Age between 25-40 years.

2. Females facing problems while initiating or maintaining sleep.

3. Willing to participate in the study after informed consent.

4. Pittsburgh Sleep Quality Instrument score higher than 5

Exclusion Criteria

1. Current use of prescribed or over-the-counter sleep medications.

2. Pregnant or lactating mother.

3. Current unusual or highly unstable sleep schedule

4. Trans-meridian travel across more than three time zones within 4

weeks prior to study entry.

5. Significant and uncontrolled major illness or psychiatric disease

6. Current life stress.

7. Use of tobacco within 6 months prior to study entry

8. Excessive use of alcohol or caffeine.

9. Currently taking hormone replacement therapy hypnotic or

psychotropic medication.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in sleep latency. <br/ ><br>Improvement in sleep qualityTimepoint: Visit 1 visit 2

Secondary Outcome Measures

Name	Time	Method
Improvement in sleep qualityTimepoint: Visit 1 visit 2