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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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. 
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