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Clinical Study on Topical Head Oil Applicatio

Phase 2
Registration Number
CTRI/2024/02/063267
Lead Sponsor
Dabur India Ltd
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1. Participants who perceive themselves to be under stress and having a score of between 14 - 24 on the Perceived Stress Scale (PSS)

2. Participants with insomnia severity more than 7 and less than or equal to 21 on insomnia severity index

3. Participants willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.

Exclusion Criteria

1. Participants currently suffering from any known chronic physical, hormonal or psychiatric illness

2. Participants with uncontrolled diabetes and hypertension

3. Participants with substance dependence e.g. taking prohibited medications such as opium, cannabis (marijuana) and methamphetamines etc.

4. Chronic alcoholics and Habitual Tobacco chewers.

6. Known cases of severe/chronic hepatic or renal disease.

7. Known case of any active malignancy.

8. Participants with history of cardiovascular event less than 12 weeks prior to recruitment.

9. Participants having known chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.

10. Participants using any other investigational drug within 1 month prior to recruitment or participants currently participating in any other Clinical study

11. Known hypersensitivity to any of the ingredients used in study products

12. Participants with any current skin or scalp related medical or surgical condition

13. Pregnant and Lactating females.

14. Other conditions, which in the opinion of the investigators, make participant unsuitable for enrolment or could interfere with his/her participation and completion of the study

Study & Design

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