| CTRI Number |
CTRI/2025/03/082241 [Registered on: 12/03/2025] Trial Registered Prospectively |
| Last Modified On: |
11/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study to evaluate the efficacy of herbal hair oil in the patient of hair fall |
|
Scientific Title of Study
|
Clinical trial to evaluate the efficacy of polyherbal hair oil(Habbul As, Amla, Mazu, Roghan kunjad) for Intithar al-Shar (diffuse hair loss): A Single arm, interventional study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Zaffar Hussain |
| Designation |
Professor Department of Moalajat |
| Affiliation |
Regional Research Institute of Unani Medicine (RRIUM), srinagar |
| Address |
Department of Moalajat RRIUM Naseem Bagh Campus of University of Kashmir Srinagar Jammu and Kashmir
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
7006021996 |
| Fax |
|
| Email |
hussainzaffar6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Zaffar Hussain |
| Designation |
Professor Department of Moalajat |
| Affiliation |
Regional Research Institute of Unani Medicine (RRIUM), srinagar |
| Address |
Department of Moalajat RRIUM Naseem Bagh Campus of University of Kashmir Srinagar Jammu and Kashmir
JAMMU & KASHMIR
190006
India |
| Phone |
7006021996 |
| Fax |
|
| Email |
hussainzaffar6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sadiya Khatoon |
| Designation |
PG Scholar |
| Affiliation |
Regional Research Institute of Unani Medicine (RRIUM), srinagar |
| Address |
Department of Moalajat RRIUM Naseem Bagh Campus of University of Kashmir Srinagar Jammu and Kashmir
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
9013389539 |
| Fax |
|
| Email |
sadiya.tibb@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research In Unani Medicine (CCRUM), New Delhi- 110058 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research In Unani Medicine CCRUM New Delhi |
| Address |
Regional Research Institute of Unani Medicine (RRIUM), University of Kashmir Srinagar- 190006 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Zaffar Hussain |
Regional Research Institute of Unani Medicine (RRIUM), Srinagar |
Moalajat opd-1, ground floor department of moalajat RRIUM naseembagh campus University of kASHMIR hazratbal
Srinagar
JAMMU & KASHMIR |
7006021996
hussainzaffar6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L659||Nonscarring hair loss, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Roghan (oil) |
It is a classical unani formulation taken from Al- Hawi. The formulation comprises of three single herbal drug namely Habbul As (Myrtus communis),Amla (Emblica officinalis), Mazu (Quercus infectoria olivier) in a compound drug Roghan kunjad (Sesamum indicum). The formulation will be given at bedtime 10 ml for local application on scalp with gentle massage daily for 2 month |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Male and female Patients of age between 18-40 years.
Hair loss more than 100 strands per day. Patients who are willing to give consent and are able to follow up
|
|
| ExclusionCriteria |
| Details |
Known cases of hypothyroidism. Patients with male androgenetic alopecia, seborrhic dermatitis, lichen planopilaris, scalp psoriasis, tinea capitis, alopecia areata, trichotillomania & scaring alopecia .Patients with surgical correction of scalp hair loss (hair transplant)
Patients who fail to give written consent.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Hair shedding Visual Scale
2) Trichoscopy |
2 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Hair pull test
2) Investigator Assessment using Photograph |
2 month |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Hair loss is a normal physiological function of the body because of the asynchronous nature of the human hair cycle. Upto 100 hair often fall out each day. Increased hair loss over 100 hairs per day is a dermatological condition that affects both men and women. Diffuse hair loss (DHL) is a highly frequent and difficult issue that affects both gender , but young to middle-aged women are more noticeable in this age group. Commonest DHL is chronic telogen effluvium(CTE) followed by female pattern hair loss (FPHL) and acute telogen effluvium(ATE). In Unani System of Medicine, hair loss is termed as Intithar al- Shar. Unani physicians have been treating this disease by different means and they have mentioned various Unani drugs (single as well as compound) in the literature for its treatment. The present medical system does not have a specific treatment for it. Therefore, the proper topical combination with a multi targeted approach may improve hair loss and achieve a quicker outcome. Keeping in view the above mentioned facts, it has been decided to evaluate the efficacy of poly herbal hair oil in the management of Intithar al-Shar (diffuse hair loss). |