Efficacy of Ayurvedic hair oil formulations in self perceived hair thinning and hair loss.

Efficacy and safety study of Ayurvedic hair oil formulations in healthy volunteers with self perceived hair thinning and hair loss.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/01/048717

Enrollment

120

Registered

2023-01-03

Start date

Unknown

Completion date

Unknown

Last updated

2025-03-03

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

Conditions

Health Condition 1: L649- Androgenic alopecia, unspecified

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1.Willing to provide voluntary written informed consent 2.Patients having selfreported thinning or hair loss for more than 6 months prior to screening 3.Patient clinically confirmed to have hair loss or thinning though physical exam for female pattern hair loss Savin Classification score of I 2 TO II 1for male pattern hair loss NorwoodHamilton classification score I AND II AND III 3.Patient willing to maintain same hair style hair color and hair regimen throughout the study and use mild non medicated shampoo during the study period 4.Women of child bearing age willing to adopt medically sound method of birth control during the trial period

Exclusion criteria

Exclusion criteria: 1. Clinical diagnosis of alopecia areata or scarring forms of alopecia or hair loss due to disease injury or medical therapy 2. Patient hypersensitive to study product or hair dye and its component. 3. History of hair transplant. 4.Patients with diagnosed organic disease of scalp with dermatological origin (other than mild to moderate dandruff determined by Adherent Scalp Flaking Score) like psoriasis, atopic dermatitis, skin cancer, eczema, sun damage, seborrheic dermatitis which requires medication. 5.Pregnant or lactating women 6.Diagnosis of organic diseases including Uncontrolled diabetes mellitus (DM), endocrinal disorder, Hypertension, neoplastic, severe cardiovascular diseases, renal insufficiency, psychiatric disorders, iron deficiency, coagulopathies etc or on any medication that can cause potential hair loss or affects hair growth.

Design outcomes

Primary

Measure	Time frame
Evaluate changes in hair densityTimepoint: Time Frame Baseline to Week 12and week 16	—

Secondary

Measure	Time frame
To analyze changes in the number of hair loss in comb test and pull test, subjective assessment of hair health variables through Modified Self-assessment questionnaire, effect on dandruff through Adherent Scalp Flaking Score (ASFS), acceptability of hair oil formulation though modified topical product usability questionnaire, Safety will be assessed at all visits through vital signs and scalp evaluations for symptoms of irritation and self observed and reported Adverse events (AEs).Timepoint: Time Frame Baseline to Week 12and week 16	—

Measure

Time frame

To analyze changes in the number of hair loss in comb test and pull test, subjective assessment of hair health variables through Modified Self-assessment questionnaire, effect on dandruff through Adherent Scalp Flaking Score (ASFS), acceptability of hair oil formulation though modified topical product usability questionnaire, Safety will be assessed at all visits through vital signs and scalp evaluations for symptoms of irritation and self observed and reported Adverse events (AEs).Timepoint: Time Frame Baseline to Week 12and week 16

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Countries

India

Contacts

Public ContactDr Sarvesh Kumar Singh

National Institute of Ayurveda,Jaipur

sarveshksingh21@gmail.com8739860237

Outcome results