Clinical trial on sleep disorders

Phase 3

Completed

• Conditions: Health Condition 1: G470- Insomnia

• Registration Number: CTRI/2023/02/049470
• Lead Sponsor: CSIR Indian Institute of Integrative Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-03-16
• Last Update Posted: 1 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

1. Male volunteers who are 18 or older to 72 years.

2. Insomnia Severity Index 10-14

3. Meet diagnostic criteria for Insomnia Disorder per DSM-5

4. Willing and able to sign Informed consent form

5. Not planning on moving away from the area for the subsequent 12 weeks

6.Subjects should not have Milk during the study

Exclusion Criteria

1. Night shift workers and individuals who nap 3 or more times per week over the preceding month

2. Consumption of caffeine beverages tea, coffee, or cola comprising usually more than 5 cups or glasses per day

3. Participation in another trial for insomnia

4. Subjects having milk on regular basis.

5. Persons who are unable to participate for the entire duration of the study, or in the opinion of the investigators, are likely to be noncompliant with the obligations inherent in the trial participation

6. Persons self describing with severe anxiety or severe depression BDI score of 29 or higher or severe anxiety BAI score of 36 or higher

7. Persons with a history of epilepsy, seizures, or dementia any significant,

severe or unstable, acute progressive medical or surgical condition stroke or head injury

8. Current alcohol or substance abuse/dependence must have greater than90 days of sobriety

9. Presence of other neurological disorders Ex multiple sclerosis, Parkinsons Disease

10. Presence of an untreated or unstable medical or psychiatric comorbid condition ex major depressive disorder or psychotic disorder requiring admission within the last two years People using psychotropic medication hypnotic or sedative medications may be included if they are on a stable dosage for the last 2 months prior to the study, if the dose remains stable throughout the study, and if the medication is judged to not interfere with the study outcomes.

11. Currently on medications known to produce insomnia ex

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. The primary end point is completion of 1-week treatment sessions on Day 0 and Day 8 with <br/ ><br>cross over assessment. <br/ ><br>2. Improvement of insomnia outcome is measured by Insomnia Severity Index (ISI), selfreported <br/ ><br>questionnaire, actigraphy, polysmonography on Day 0 & Day 8.Timepoint: Day 0 & Day 8.

Secondary Outcome Measures

Name	Time	Method
The Secondary end point is improvement in biomarker values from Day 0 to Day 8Timepoint: Day 0 & Day 8.