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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

A Prospectivestudy to evaluate the Safety and Efficacy of Investigational Anti-Dandruff shampoo in comparison with Comparator Anti-Dandruff shampoo in subjects with wet and dry dandruff

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/05/014181
Enrollment
40
Registered
2018-05-29
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Dheedhi anti dandruff herbal Shampoo: Dheedhi anti dandruff herbal Shampoo Control Intervention1: Himalaya Anti-Dandruff shampoo: Himalaya Anti-Dandruff shampoo Control Intervention2: M

Sponsors

Dhathri Ayurveda Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Scales to rate over-all experience of the study product with respect to the â?¢ Reduction of dry and wet flakes â?¢ Itching of scalp â?¢ Antifungal and antimicrobial activity. â?¢ Dandruff control Timepoint: visit1 day1 visit2 day3 visit3 day5 visit4 day7 visit5 day14 visit6 day21

Secondary

MeasureTime frame
1. Visible hair fall reduction 2. Hair growth improvement (length & thickness) 3. Reduction of hair damage (split ends, breakages) 4. Improvements in hair strength & elasticity of hair 5. Texture and appearance (softness, smoothness, shine) 6. Scalp itching & dandruff 7. Product lightness and non-stickiness 8. Feedback on product smell & smell retention on hair 9. Mildness and non-irritant property Timepoint: Visit 06 day21

Countries

India

Contacts

Public ContactPreeti A

Dhathri Ayurveda Pvt Ltd

doctor@dhathri.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026