| CTRI Number |
CTRI/2025/09/094064 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Unani |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of efficacy of Polyherbal Formulations in Management of Chronic Telogen Effluvium in healthy Females. |
|
Scientific Title of Study
|
Evaluation of efficacy and safety of Unani Formulations in management
Of Intithar al Shar (Chronic Telogen Effluvium) in healthy females. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mehrun Nisa |
| Designation |
PG Scholar |
| Affiliation |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital |
| Address |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus kolar bypass road Bhopal Madhya Pradesh Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus Kolar bypass road Bhopal Madhya Pradesh Bhopal MADHYA PRADESH 462003 India |
| Phone |
9340593248 |
| Fax |
|
| Email |
nisamehrun562@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Mohammad Anzar Husain |
| Designation |
Professor and HOD |
| Affiliation |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital |
| Address |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus kolar bypass road Bhopal Madhya Pradesh Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus Kolar bypass Road Bhopal Madhya Pradesh 462003 Bhopal MADHYA PRADESH 462003 India |
| Phone |
7000097052 |
| Fax |
|
| Email |
mohdanzarhusain@yahoo.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Mehrun Nisa |
| Designation |
PG Scholar |
| Affiliation |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital |
| Address |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus kolar bypass road Bhopal Madhya Pradesh Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush campus kolar bypass road Bhopal Madhya Pradesh 462003 Bhopal MADHYA PRADESH 462003 India |
| Phone |
9340593248 |
| Fax |
|
| Email |
nisamehrun562@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Bhopal Madhya Pradesh Medical Science University Jabalpur 482003 Madhya Pradesh |
|
|
Primary Sponsor
|
| Name |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital |
| Address |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus kolar bypass road Bhopal Madhya Pradesh |
| Type of Sponsor |
Government medical college |
|
|
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 Mehrun Nisa |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital |
OPD No.5 Department of Amraz e Jild wa Tazeeniyat Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus Kolar Bypass Road Bhopal Madhya Pradesh Bhopal MADHYA PRADESH |
9340593248
nisamehrun562@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L650||Telogen effluvium, (2) ICD-10 Condition: L650||Telogen effluvium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Jwaraish Jalinoos Qurs Kushta Khabsulhadded Roghne Baizae Murgh |
The Test Group Will Be Given Jwarasih Jalinoos 7gm BD Orally
Qurs Kushta Khabsulhadeed 2BD Orally and Roghane Baizae Murgh Locally On Scalp Used Alternetly for 56 Days |
| Comparator Agent |
Roghane Baizae Murgh |
Comparator group will be given Only Roghane Baizae Murgh used Locally on Scalp alternatly for 56 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Clinically diagnosed patient of chronic telogen effluvium.
2.Patients having natural hair colour.
3.Patient who will give written consent and able to do follow up. |
|
| ExclusionCriteria |
| Details |
1.Pregnant women and nursing mothers.
2.Previous hair growth procedure within 3 months.
3.Patient suffering from local infection of the scalp allergic reactions active seborrhic dermatitis.
4.Patient suffering from chronic illnesses like diabetes mellitus thyroid disorders kidney and liver dysfunctions carcinoma tuberculosis.
5.Patients who used topical minoxidil within 6 months prior to enrolment.
6.Patients with surgical correction of scalp hair loss hair transplant or scalp reduction. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Patient Self Assessment
2.Hair comb test 3.Hair pull test |
Baseline 28th day 56th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life questionnaire |
Baseline 56th day |
|
|
Target Sample Size
|
Total Sample Size="44" Sample Size from India="44"
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)
|
15/09/2025 |
| 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 Yet Recruiting |
| 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 fall is a common cosmetic concern affecting about 1.7 percent of the global population often leading to psychological distress and reduced quality of life. The major types of hair loss include telogen effluvium alopecia areata and androgenetic alopecia with varying prevalence worldwide and in India. Telogen effluvium one of the most frequent causes arises from a shortened anagen phase triggered by physiological or psychological stress. It occurs in acute and chronic forms and latter affecting mainly middle aged women without noticeable thinning but with decreased hair volume and length and often idiopathic in origin. The normal hair cycle consists of anagen 3 to 5 years catagen 2 to 3 weeks and telogen 3 to 4 months with daily shedding of up to 100 hairs considered normal but excessive shedding beyond this limit characterizes telogen effluvium. In Unani medicine hair loss Intithar al shar is attributed to nutritional deficiencies impaired production of bukharat i dukhaniyya skin laxity morbid matter accumulation or fibrosis. Management includes drugs with properties such as Tadil e Mizaj (temperament correction) Taghziya (nutritional support) muqawwi e dimagh (brain tonic) and Munbit e shar (hair growth promotion). These formulations are considered safe with no adverse effects reported in classical literature .In contrast modern medicine provides pharmacological and surgical options such as minoxidil finasteride nutritional supplements and low-level light therapy. However these require continuous use may have limited efficacy and are associated with adverse effects. Considering the safety and efficacy described in traditional texts the present study is designed to evaluate Unani polyherbal formulations in the management of chronic telogen effluvium in healthy females. |