Effect of herbal formulation on hair health

Phase 2

Conditions: Health Condition 1: L659- Nonscarring hair loss, unspecified

Registration Number: CTRI/2023/07/055432

Lead Sponsor: Plantayu life science LLP

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Age from 18 - 60 yrs

2.Male or female

3.Willing to provide voluntary written informed consent.

4.Patients having self-reported thinning or hair loss for more than 6 months prior to screening

5.Patient clinically confirmed to have hair loss or thinning though physical exam ( for female pattern hair loss Savin Classification score of I 2-II 1,[4] for male pattern hair loss Norwood-Hamilton classification score I, II, III) [5]

6.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.

7.Women of child bearing age willing to adopt medically sound method of birth control during the trial period.

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.

7.Refusal to provide informed consent

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate changes in Target Area Hair Count (TAHC) measured by Dermobella hair analyzer.Timepoint: base line to 60 days

Secondary Outcome Measures

Name	Time	Method
To analyze changes in number of hair loss in comb test & pull test, subjective assessment of hair health variables though 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: base line to 12 weeks