Clinical study to evaluate effectiveness, safety and tolerability of Dhathri Hair Care Plus Herbal Oil in comparison with Coconut Oil in the management of hairfall, premature graying of hair and dandruff of the scalp

A randomised, open label, prospective, two arms, parallel group study to evaluate the effectiveness, safety and tolerability of Dhathri Hair Care Plus Herbal Oil in comparison with Coconut Oil in the management of alopecia, premature graying of hair and seborrheic dermatitis of the scalp in adults.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/04/003593

Enrollment

Registered

2013-04-29

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

Health Condition 1: L659- Nonscarring hair loss, unspecified Health Condition 2: L219- Seborrheic dermatitis, unspecified Health Condition 3: L671- Variations in hair color

Interventions

Intervention1: Dhathri Hair Care Plus Herbal Oil: A Herbal (Ayurvedic) oil intended to be used in the management of hairfall, premature graying of the hair and dandruff of the scalp. THE DOSE: 7 ml p

ROUTE OF ADMINISTRATION: Topical Control Intervention1: Coconut Oil: Comparator THE DOSE: 7 ml per day, FREQUENCY DURATION: daily once for 6 weeks

ROUTE OF ADMINISTRATION: Topical

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects between the age group of 21 to 45 years. 2. Subjects who are able to give written informed consent and ready to comply with the protocol. 3. Subjects with active alopecia, premature graying of hair - â??Gray Hair Shade Card Assessment >=50%â?? and seborrheic dermatitis of the scalp â?? â??Total ASFS Score >= 16 4. Subjects with a minimum hair length of 2 inches and willing to maintain the same minimum length, hair style until the end of the study.

Exclusion criteria

Exclusion criteria: 1. Subjects on topical treatment for alopecia, premature graying of the hair and seborrheic dermatitis for 8 weeks prior to enrollment. 2. Subject with other dermatological disorders of the scalp that might interfere with the study evaluation. 3. Subjects with significant scalp scarring. 4. Subjects who have anemia or iron deficiency. 5. Subjects who have previously undergone hair transplantation procedures. 6. History of systemic or cutaneous malignancy or evidence of immunocompromised state. 7. Subjects with history of skin allergy. 8. Subjects on systemic steroids for more than 14 days within 2 months prior to enrollment. 9. Female subjects who are reported pregnant/planning a pregnancy or lactating. 10. Subjects who are currently enrolled in an active investigational study or have participated in an investigational study within 30 days prior to enrollment. 11. Subjects, who in the opinion of the Investigator or the Expert Dermatologist are not eligible for enrollment in the study.

Design outcomes

Primary

Measure	Time frame
1. Excellent reduction in the shedding range of the hair in the â??60 Second Hair Comb testâ?? from Visit 1 to end of the study. 2. Excellent reduction in the flaking severity in â??Adherent Scalp Flaking Scoreâ?? from Visit 1 to end of the study.Timepoint: 60 second Hair Comb Test: 50% reduction in the shedding range from V 1-V3 ASFS:Reduction of 10 or to 0 score from V1-V3 Gray Hair Shade Card Assessment: Reduction of 20% of gray hair from V 1-V 3. Objective Hair Assessment Questionnaire:Decrease by 10 scores from V1-V 3 Subjective Hair Assessment Questionnaire: Decrease by 5 scores from V1-V3 Subject IP Feedback Questionnaire: Total score of 12 in V 2&V3 Worsening of alopecia, premature graying & seborrheic dermatitis of the scalp	—

Measure

Time frame

1. Excellent reduction in the shedding range of the hair in the â??60 Second Hair Comb testâ?? from Visit 1 to end of the study. 2. Excellent reduction in the flaking severity in â??Adherent Scalp Flaking Scoreâ?? from Visit 1 to end of the study.Timepoint: 60 second Hair Comb Test: 50% reduction in the shedding range from V 1-V3 ASFS:Reduction of 10 or to 0 score from V1-V3 Gray Hair Shade Card Assessment: Reduction of 20% of gray hair from V 1-V 3. Objective Hair Assessment Questionnaire:Decrease by 10 scores from V1-V 3 Subjective Hair Assessment Questionnaire: Decrease by 5 scores from V1-V3 Subject IP Feedback Questionnaire: Total score of 12 in V 2&V3 Worsening of alopecia, premature graying & seborrheic dermatitis of the scalp

—

Secondary

Measure	Time frame
1. Reasonable improvement in the â??Gray Hair Shade Card Assessmentâ?? from Visit 1 to end of the study. 2. Reasonable improvement in the â??Objective Hair Assessment Questionnaireâ?? score from Visit 1 to end of the study. 3. Reasonable improvement in the â??Subjective Hair Assessment Questionnaireâ?? score from Visit 1 to end of the study. 4. Reasonable improvement the â??Subject IP Feedback Questionnaireâ?? score from Visit 2 to end of study.Timepoint: 60 second Hair Comb Test: 25-49% reduction in the shedding range from V1-V3 ASFS: Reduction of 6 Score from V 1-V3 Gray Hair Shade Card Assessment â?? Reduction of 10% percentage of gray hair from V 1-V3 Objective Hair Assessment Questionnaire:Decrease by 5 scores from V1-V3 Subjective Hair Assessment Questionnaire: Decrease by 3 scores from V1-V3 Subject IP Feedback Questionnaire: Total score of 6 in V 2&V 3 Development of adverse reactions due to the usage of the IP/comparator.	—

Measure

Time frame

1. Reasonable improvement in the â??Gray Hair Shade Card Assessmentâ?? from Visit 1 to end of the study. 2. Reasonable improvement in the â??Objective Hair Assessment Questionnaireâ?? score from Visit 1 to end of the study. 3. Reasonable improvement in the â??Subjective Hair Assessment Questionnaireâ?? score from Visit 1 to end of the study. 4. Reasonable improvement the â??Subject IP Feedback Questionnaireâ?? score from Visit 2 to end of study.Timepoint: 60 second Hair Comb Test: 25-49% reduction in the shedding range from V1-V3 ASFS: Reduction of 6 Score from V 1-V3 Gray Hair Shade Card Assessment â?? Reduction of 10% percentage of gray hair from V 1-V3 Objective Hair Assessment Questionnaire:Decrease by 5 scores from V1-V3 Subjective Hair Assessment Questionnaire: Decrease by 3 scores from V1-V3 Subject IP Feedback Questionnaire: Total score of 6 in V 2&V 3 Development of adverse reactions due to the usage of the IP/comparator.

—

Countries

India

Contacts

Public ContactDr VT Sriraam

Raam Poly Clinic

raampolyclinic@gmail.com9840909155

Outcome results

None listed

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