A clinical trial to study the effect of herbal hair treatment on hair loss

Phase 4

Completed

• Conditions: Indian adult volunteers suffering in hair loss or growth or problems related to hairs

• Registration Number: CTRI/2020/04/024543
• Lead Sponsor: Allen Laboratories Limited

Brief Summary

This study is an open label, phase 4, single centre trial to monitor the toxicity, risks, utility, benefits and optimal use after the efficacy of ArnikaPlus Combo Pack, containing (ArnikaPlus Aqua Base Hair Root Vitalizer,  ArnikaPlus-S Anti-dandruff Hair & Scalp Cleanser and ArnikaPlus Oil Hair Root Nourisher)  for 12 weeks in 100 patients to diffuse hair loss/ slow growth of hair that will be conducted in India. For selection of subjects Patch test and following biochemical tests will be assessed: Complete Blood Count (TC, DC, ESR, Hb, PCV, MCV, MCH, MCHC), Blood glucose (F), Dihydrotestosterone (Male), TSH, Total protein, Serum Iron, Oestrogen (Female) and USG lower abdomen (to exclude PCOD). Subjects will follow up at 4 weeks, 8 weeks, and at 12-week treatment endpoint. Clinical efficacy will be assessed by Global photographs (vertex, mid-pattern, frontal, and temporal views), Hair distribution and growth test (7 Point VAS), Hair pull test (right, left, parietal, frontal and occipital areas), Comb test and Assessment of dandruff. Data will be statistically analyzed by examining the improvement score at treatment endpoint in a multivariable linear regression analysis with group and baseline score as the independent variables. Alpha for statistical significance will be set at p less than 0.05.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-11-03
• Study Start: 2021-01-02
• Study Completion: 2021-10-31

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 1.Male and female participants in the age group of 18-40 years.
• 2.Participants willing to give informed consent.
• 3.Participants willing to comply with the study procedures.
• 4.Participants who are fit and no need any hospital administration.
• 5.Complaints for diffuse hair loss/ slow growth of hair.
• 6.Complaints for dandruff and lice.
• 7.Complaints for bad quality of hair (elasticity, strength, fragility, longevity, smoothness).
• 8.Complaints for fungal infection.

Exclusion Criteria

• 1.History of systemic or cutaneous malignancy or lesions.
• 2.History of psoriasis, polycystic ovarian syndrome.
• 3.Advanced or poorly controlled thyroidisms, diabetes and anemia.
• 4.Unstable cardiovascular disease.
• 5.Clinically significant medical or psychiatric disease.
• 6.Evidence of immunocompromised state.
• 7.Serious local infection (e.g. cellulites, abscess) or systemic infection (e.g. pneumonia, septicemia) within six months prior to enrollment.
• 8.Pregnant and lactating women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the efficacy of test products in diffuse hair fall and growth of new hair and hair quality improvement	8 months

Secondary Outcome Measures

Name	Time	Method
To assess the efficacy of test products in diffuse hair fall and growth of new hair and hair quality improvement	3 months

Trial Locations

Locations (1)

Research Unit JB Roy State Ayurvedic Medical College and Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

Research Unit JB Roy State Ayurvedic Medical College and Hospital

🇮🇳Kolkata, WEST BENGAL, India

Dr Tuhin Kanti Biswas

Principal investigator

9433173272

jbrtkbiswas@gmail.com