| CTRI Number |
CTRI/2025/08/093823 [Registered on: 28/08/2025] Trial Registered Prospectively |
| Last Modified On: |
27/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study on the comparison of two unani formulations in the management of White patches. |
|
Scientific Title of Study
|
A Single-Blind Randomized Clinical trial of Unani formulations in the treatment of Bahaq (Pityriasis). |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohd Riyaz Alam |
| Designation |
PG Scholar |
| Affiliation |
Ajmal Khan Tibbiya College |
| Address |
Department of Amraz-e-Jild wa Zohrawiya, Faculty of Unani medicine, Aligarh Muslim University
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
7302507546 |
| Fax |
|
| Email |
riyazlm103@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ZAMIR AHMAD |
| Designation |
PROFESSOR |
| Affiliation |
Ajmal Khan Tibbiya College |
| Address |
Department of Amraz-e-Jild wa Zohrawiya, Faculty of Unani medicine, Aligarh Muslim University
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
8475007594 |
| Fax |
|
| Email |
drzamiramrohi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohd Riyaz Alam |
| Designation |
PG Scholar |
| Affiliation |
Ajmal Khan Tibbiya College |
| Address |
Department of Amraz-e-Jild wa Zohrawiya, Faculty of Unani medicine, Aligarh Muslim University
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
7302507546 |
| Fax |
|
| Email |
riyazlm103@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Amraz-e-Jild wa Zohrawiya, Ajmal Khan Tibbiya College, AMU, Aligarh |
|
|
Primary Sponsor
|
| Name |
Department of Amraz-e-Jild wa Zohrawiya |
| Address |
Ajmal Khan Tibbiya College, Facuylty of Unani Medicine, AMU |
| 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 |
| Mohd Riyaz Alam |
Ajmal Khan Tibbiya College and Hospital |
OPD No. 3, Department of Amraz-e-Jild wa Zohrawiya, AKTC Hospital, Faculty of Unani Medicine, AMU
Aligarh
UTTAR PRADESH |
7302507546
riyazlm103@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Department of Amraze Jild wa Zohrawiya |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L819||Disorder of pigmentation, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparator drug - Sheetraj hindi (Plumbago zeylanica) and Roghan Bedanjeer (Castor oil) Ricinus communis |
Sheetraj hindi- (Plumbago zeylanica Linn.), a perennial shrub, also known by the name of “Chitrak”, “Cheeta lakdi” belongs to Plumbaginaceae family. Root is used as drug. In Unani dermatology it is used in the treatment of Pityriasis, itching, Allergy. It also acts as Anti-inflammatory, Anti-microbial and Anti-hyperlipidemic. |
| Intervention |
Test Drug- Turmus (Lupinus albus) and Roghan Bedanjeer (Castor oil) Ricinus communis
|
Turmus (Lupinus albus), commonly known as white lupin or lupine, is a leguminous plant. Root of Turmus is used in Zimad form. It is used as antimicrobial, Antifungal, Anti-helmintic, etc |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Includes all gender with age 03 years and above (School going children).
2. Diagnosed cases of Bahaq over hands, legs, neck and face.
3. Patients who agreed to sign the consent form.
|
|
| ExclusionCriteria |
| Details |
1.All gender patients below 03 years.
2.Patients with other concomitant skin diseases.
3.Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in sign and symptoms- Hypopigmentation, scaling and itching. |
3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in the condition on the basis of photographs |
0, 14th and 21st day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
18/09/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Objective of the study: To assess the comparative efficacy & safety of the Topical Application of Turmus and Sheetraj hindi ointment in the treatment of Bahaq. |