A clinical trial to study the effect of Ashwagandha on Transient Insomnia

Phase 4

Registration Number: CTRI/2020/12/029647

Lead Sponsor: International Institute of Sleep Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Individuals who are willing to participate in the study and signed the informed consent will be screened for the study. The target population includes individuals residing in Mumbai and Thane, India (to facilitate logistics and investigations). In addition to we will adhere to the following inclusion criteria

1.Individual in good health with normal hearing

2.Individuals with normal sleep habits with PSQI scores < 5

3. Women of child-bearing potential (WOCBP, refer to the appendix for definition) willing to use an adequate method of contraception to avoid pregnancy throughout the study period.

Exclusion Criteria

Individuals with any heart-related problems such as IHD, VHD, Pacemakers.

Those with moderate to severe sleep apnea, RLS, Narcolepsy, respiratory, and seizure disorder.

Individuals who have traveled in time zones in the past 3 months.

Participants who have worked in shifts in the past 4 weeks.

Individuals with severe grade untreated depression.

Women who are pregnant or nursing.

Participants taking over the counter medicines, herbal medicines which are anxiolytics, CNS active drugs, antidepressants, those working on the sleep-wake cycle.

History of drug addiction/abuse in the last 12 months.

History of alcohol abuse within the past 12 months, as defined in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised and/or regularly consumes more than 2 alcoholic drinks per day

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean percent change in CAP score in Treatment only night PSG and Treatment with Noise induced transient Insomnia night PSG.Timepoint: Visit3 Visit4 Visit5 <br/ ><br>Visit6 Visit7 Visit8 <br/ ><br>Visit9 Visit10 Visit 11 <br/ ><br>Visit12 Visit13

Secondary Outcome Measures

Name	Time	Method
Mean percentage in treatment nights for <br/ ><br>PSG and Actiwatch paramters Mean number change in RSQ-D again for treatment nights only.Timepoint: Visit3 Visit4 Visit5 <br/ ><br>Visit6 Visit7 Visit8 <br/ ><br>Visit9 Visit10 Visit 11 <br/ ><br>Visit12 Visit13