Safety evaluation of 18 herbs organics Stress Relief OI
- Registration Number
- CTRI/2022/08/044881
- Lead Sponsor
- Buy happy Marketing LLP
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
1.Healthy Men and women volunteers are chosen in ratio of 1:1 aged > 35 and < 60years.10% of
the sample size, are chosen such that who are having anxiety and stress.
2.Subjects who are willing to participate in the study and sign the informed consent document
and comply with the trial procedure.
3.Having healthy skin on test area as assessed by dermatological examination and donââ?¬•t have
history of allergy.
1.Pregnant/nursing mothers.
2.Scars, excessive terminal hair, or tattoo on the studied area.
3.Dermatological infection/pathology on level of studied area.
4.Hypersensitivity, allergy antecedent (to any cosmetic product, raw material)
5.Any clinically significant systemic or cutaneous disease, which may interfere with study
treatment or procedures.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of subjects that showed no significant irritation. <br/ ><br> Score of less than or equal to 2 on the Draize scaleTimepoint: DAY 0,1,2,3,4,5
- Secondary Outcome Measures
Name Time Method ATimepoint: NA