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the Study Safety and Efficacy of Anti-Dandruff shampoo in comparison with Anti-Dandruff shampoo in subjects with wet and dry dandruff

Phase 4
Completed
Registration Number
CTRI/2018/05/014181
Lead Sponsor
Dhathri Ayurveda Pvt Ltd
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
40
Inclusion Criteria

1.Willingness to give written informed consent.

2.Subjects in the range of 18-50 years of age.

3.Subjects with wet and dry dandruff.

4.Subjects with no skin allergies to any cosmetic products.

5.Willingness to discontinue any hair care product other than the IP throughout the study.

6.Subjects who are not willing to color their hair throughout the treatment period.

7.Subjects willing to stop all the hair care treatments such as hair spa, straightening, curling, perming, etc. throughout the treatment period.

8.Willingness to follow the protocol requirements as evidenced by written informed consent.

9.Subjects able to understand the nature and purpose of the study and compliance with the requirement of the entire procedure.

10.In addition, female subjects selected for the study must be able to use a medically acceptable form of birth control during the study or be surgically sterile or be post-menopausal for at least 1 year.

Exclusion Criteria

1.Subjects with known hypersensitivity to any specific ingredients of IP.

2.Subjects below the age of 18 years and subjects above 50 years.

3.Subjects not willing to participate in the study.

4.Subjects who have previously undergone hair transplantation procedures.

5.Subjects with any skin diseases.

6.Subjects being treated for hair fall or severe active infections of any type previously.

7.Presence of any underlying significant uncontrolled medical illness involving the cardiovascular, respiratory, renal, gastrointestinal, hepatic, immunologic, hematological, endocrine, or nervous system-s or psychiatric disease and HIV.

8.Subjects with pre-existing scalp disorder such as scalp psoriasis, lichen planus, lichen planopilaris, DLE Discoid lupus erythematosus, sebopsoriasis.

9.A female subject who is breast-feeding, pregnant, or intends to become pregnant during the study.

10.Participating in a clinical research trial within 30 days prior to screening.

11.Subjects who are cognitively impaired and/or who are unable to give informed consent.

12.Any other health or mental condition that in the Investigatorâ??s opinion may adversely affect the ability to complete the study or its measures or that may pose significant risk to the subject.

Study & Design

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