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A clinical trial to study the effect of Holy Basil on sleep quality in moderately stressed participants

Phase 3
Conditions
Health Condition 1: - Health Condition 2: F438- Other reactions to severe stress
Registration Number
CTRI/2023/10/059316
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

The following criteria are to be checked at the time of screening. The participant may only be included in the study if ALL the following statements are FULLFILLED:

1.With age of at least 18 years to 65 years

2.PSS score > 14

3.Have not taken any hypnotic medicines, Supplements within last 3 months.

4.Able to communicate and read in English.

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

6.No Caffeine or Alcohol intake 12 hours prior to Polysomnogram study

7.Willing to provide written informed consent.

Exclusion Criteria

Participants with heart disease, sleep disorders such as OSA and PLMD, with hepatic impairment,

those working in shifts, history of drug abuse and on any sedating medications

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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