| 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
|
|
|
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
|
|
|
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. |