| CTRI Number |
CTRI/2020/04/024543 [Registered on: 09/04/2020] Trial Registered Prospectively |
| Last Modified On: |
11/03/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study the effect of herbal hair treatment on hair loss |
|
Scientific Title of Study
|
An open label, phase IV, randomized clinical trial of ArnikaPlus Combo Pack on hair problems |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| JBR/RU/CT-13/19 version 1 dated May 5, 2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tuhin Kanti Biswas |
| Designation |
Professor |
| Affiliation |
JB Roy State Ayurvedic Medical College and Hospital |
| Address |
JB Roy State Ayurvedic Medical College and Hospital
170 172 Raja Dinendra Street Kolkata West Bengal India
Kolkata
WEST BENGAL
700004
India |
| Phone |
9433173272 |
| Fax |
|
| Email |
jbrtkbiswas@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Srikanta Pandit |
| Designation |
Associate Professor |
| Affiliation |
JB Roy State Ayurvedic Medical College and Hospital |
| Address |
Department of Kayachikitsha
JB Roy State Ayurvedic Medical College and Hospital
170 172 Raja Dinendra Street Kolkata West Bengal India
Kolkata
WEST BENGAL
700004
India |
| Phone |
9831723650 |
| Fax |
|
| Email |
srikantapandit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Utpalendu Jana |
| Designation |
Principal |
| Affiliation |
JB Roy State Ayurvedic Medical College and Hospital |
| Address |
JB Roy State Ayurvedic Medical College and Hospital
170 172 Raja Dinendra Street Kolkata West Bengal India
Kolkata
WEST BENGAL
700004
India |
| Phone |
|
| Fax |
|
| Email |
janauin@gmail.com |
|
|
Source of Monetary or Material Support
|
| Allen Laboratories Limited |
|
|
Primary Sponsor
|
| Name |
Allen Laboratories Limited |
| Address |
Allen Estate
Krishnapur Road, Kestopur, Kolkata, India
PIN 700 102
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tuhin Kanti Biswas |
Research Unit JB Roy State Ayurvedic Medical College and Hospital |
Raja Dinendra Street, Kolkata, West Bengal, India
Kolkata
WEST BENGAL |
9433173272
jbrtkbiswas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Indian adult volunteers suffering in hair loss or growth or problems related to hairs |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ArnikaPlus Combo Pack |
ArnikaPlus Combo Pack, contains the following products-
ArnikaPlus Aqua Base Hair Root Vitalizer, ArnikaPlus-S Anti-dandruff Hair Scalp Cleanser and ArnikaPlus Oil Hair Root Nourisher
Mode of use: ArnikaPlus Aqua Base Hair Root Vitalizer will be use during bed time - 5 ml every night in scalp hair for 90 days.
ArnikaPlus-S Anti-dandruff Hair Scalp Cleanser will be use 15 min before bath - 5 ml every day in scalp hair for 90 days.
ArnikaPlus Oil Hair Root Nourisher will be use after bath in dry hair 5-10 ml everyday for 90 days.
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of test products in diffuse hair fall and growth of new hair and hair quality improvement |
8 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of test products in diffuse hair fall and growth of new hair and hair quality improvement |
3 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "103"
Final Enrollment numbers achieved (India)="103" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/02/2021 |
| Date of Study Completion (India) |
31/10/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |