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CTRI Number  CTRI/2026/01/100430 [Registered on: 06/01/2026] Trial Registered Prospectively
Last Modified On: 06/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Comparative Study to evaluate the efficacy of Roghan-e-Zarareeh(oil) & Leech Therapy in Alopecia Areata  
Scientific Title of Study   An Open labelled Randomized Comparative Study to evaluate the efficacy of Roghan-e-Zarareeh & Leech Therapy in Dau’salab (Alopecia Areata) 
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 GORUKALLU ABBAS AHMED 
Designation  PG SCHOLAR 
Affiliation  GOVERNMENT NIZAMIA TIBBI COLLEGE 
Address  OP NO 107 PG Department of Moalijat Government Nizamia Tibbi College and General Hospital Charminar Hyderabad 500002 INDIA
OP No 122 PG Department of Moalijat Government Nizamia Tibbi College and General Hospital Charminar Hyderabad 500002 INDIA
Hyderabad
TELANGANA
500002
India 
Phone  9533381820  
Fax    
Email  abbasahmed7522@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr N Narasimha  
Designation  Professor 
Affiliation  Government Nizamia Tibbi College 
Address  OP No 107 PG Department of Moalijat Government Nizamia Tibbi College and General Hospital Charminar Hyderabad TELANGANA 500002 INDIA

Hyderabad
TELANGANA
500002
India 
Phone  9866985269  
Fax    
Email  dr.n.narasimha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr N Narasimha  
Designation  Professor 
Affiliation  Government Nizamia Tibbi College 
Address  OP No 107 PG Department of Moalijat Government Nizamia Tibbi College and General Hospital Charminar Hyderabad TELANGANA 500002 INDIA

Hyderabad
TELANGANA
500002
India 
Phone  9866985269  
Fax    
Email  dr.n.narasimha@gmail.com  
 
Source of Monetary or Material Support  
Government Niamia Tibbi College and Hospital, Hyderabad. No external monetary or material support. 
 
Primary Sponsor  
Name  Govt Nizamia Tibbi College Hyderabad 
Address  PG Department of Moalijat Government Nizamia Tibbi College and General Hospital 
Type of Sponsor  Research institution and hospital 
 
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 GORUKALLU ABBAS AHMED  Government Nizamia Tibbi College and General Hospital  OP NO 107 PG Department of MoalijatGovernment Nizamia Tibbi College and General Hospital Charminar Hyderabad TELANGANA
Hyderabad
TELANGANA 
9533381820

abbasahmed7522@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute ethics committee IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L639||Alopecia areata, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Irsal-e-Alaq (Leech Therapy)  Medicinal leech therapy on affected scalp regions as per Unani protocol. 4 – 10 sessions per participant, each 45 – 60 minutes, performed under aseptic precautions. Total treatment period about 12 weeks. 
Intervention  Roghan-e-Zarareeh (Topical application)  Roghan-e-Zarareeh (Unani medicated oil) applied over affected scalp areas once daily or as per need for 12 weeks. Standard hair-care instructions provided. Duration of each application about 15 minutes to 1 hour. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Clinically diagnosed cases of Dau’salab (Alopecia Areata) with open follicular pores (orange-surface appearance).
2.Age between 18 and 50 years, either sex.
3.Patients willing to give written informed consent and comply with study protocol.
4.Hb more than 8 gdL. 
 
ExclusionCriteria 
Details  1.Patients with androgenic alopecia, tinea capitis, traction alopecia or telogen effluvium.
2.Patients with hereditary alopecia.
3.Patients with diabetes mellitus.
4.Patients on anticoagulant therapy.
5.Patients with bleeding disorders.
6.Patients with hemoglobin less than 8 g/dL.
7.Patients with alopecia involving eyebrows or eyelashes.
8.Patients with closed follicular pores, scarring or fibrosis of scalp.
9.Patients with other systemic illness affecting hair growth. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in Severity of Alopecia Tool (SALT) score indicating reduction in number and size of alopecia patches from baseline to end of treatment.  Baseline and at the end of treatment period. 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
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)   10/02/2026 
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="0"
Months="2"
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  

Alopecia areata is an autoimmune disorder that can lead to unpredictable hair loss. Scientists believe the cause is genetic, as it tends to run in families. Alopecia Areata is a type of non-scarring alopecia that effects males and females equally and occurs in both children and adults. There is currently no cure for alopecia areata, although there are some forms of treatment that can be suggested by doctors to help hair re-grow more quickly. Some have compared alopecia areata to vitiligo, an autoimmune skin disease in which the body attacks melanin-producing cells, leading to white patches. Research suggests that these two conditions may share a similar pathogenesis, with similar types of immune cells and cytokines driving the diseases and common genetic risk factors.

According to Unani Dau’salab , Daul’Hayya meaning the disease of Fox and Snake for those reasons of resemblances of these two animals which often suffers from this condition. According to IBN-E-SINA, a legendary Unani Physician, the disease can occur in any part of body but scalp, face and eyebrows are the commonest sites.


According to UNANI: -   The disease is commonly characterized by the accumulation of morbid  humours. It has been considered to be caused by infection either directly or as a consequence  of remote ‘focus of infection’. Viral infection is the most common cause of infection especially  Cytomegalovirus, Epstein Barr virus, Swine flu virus etc. The antigen of  these viruses is present   in blood for a long time thus causing Fasad-e-Dam. These antigens have their antibodies  circulating in blood, sometimes they cause exaggerated immune response in body, thus   Alopecia Areata is considered mainly autoimmune disease.

 
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