| CTRI Number |
CTRI/2025/07/091653 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
18/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani
Other (Specify) [UNIM 001 UNIM 003 NB UVB Therapy] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Management of vitiligo through coaded unani formulations |
|
Scientific Title of Study
|
A COMPARATIVE STUDY OF CODED UNANI FORMULATION UNIM 001 UNIM 003 AND NB UVB THERAPY IN CASES OF BARAS VITILIGO FOLLOWUP STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Misbahuddin Azhar |
| Designation |
Research Officer Scientist IV |
| Affiliation |
Regional Research Institute of Unani Medicine |
| Address |
Shanjahan Manzil
Near AMU Riding Club
Qila Road Aligarh
Central council for Research in Unani Medicine
61 65 Institutional Area
Opp D Block Janakpuri
New Delhi 110058
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
8383096715 |
| Fax |
|
| Email |
ccrum619@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Misbahuddin Azhar |
| Designation |
Research Officer Scientist IV |
| Affiliation |
Regional Research Institute of Unani Medicine |
| Address |
Shanjahan Manzil
Near AMU Riding Club
Qila Road Aligarh
Central council for Research in Unani Medicine
61 65 Institutional Area
Opp D Block Janakpuri
New Delhi 110058
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
8383096715 |
| Fax |
|
| Email |
ccrum619@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Misbahuddin Azhar |
| Designation |
Research Officer Scientist IV |
| Affiliation |
Regional Research Institute of Unani Medicine |
| Address |
Shanjahan Manzil
Near AMU Riding Club
Qila Road Aligarh
Central council for Research in Unani Medicine
61 65 Institutional Area
Opp D Block Janakpuri
New Delhi 110058
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
8383096715 |
| Fax |
|
| Email |
ccrum619@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Unani Medicine
61 65 institutional Area
Opp D Block
Janakpuri New Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council for research in Unani Medicine |
| Address |
61 65 institutional Area
Opp D Block
Janakpuri New Delhi
Ministry of Ayush Government of india |
| Type of Sponsor |
Research institution |
|
|
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 MISBAHUDDIN AZHAR |
Regional Research Institute of Unani Medicine Aligarh |
Central Hall OPD
SHAHJAHAN MANZIL
NEAR AMU RIDING CLUB
QILA ROAD ALIGARH
Aligarh
UTTAR PRADESH |
8383096715
ccrum619@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe of RRIUM Aligarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L80||Vitiligo, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
UNIM 001
UNIM 003
UNIM 001 placebo
UNIM 003 Placebo
NB UVB Therapy |
All the selected subject will be divided into three groups. Group–I will receive UNIM-001 oral twice in days in the dose of 2 capsule or one capsule according to age and UNIM-003 diluted in water applied locally at the site in appropriate quantity along with the exposure of NB UVB phototherapy at Dept. of Amraz-e-Jild wa Taziniyat, initially for 10 days regular and thereafter from day 11 to 30 alternate days and for next two months it will twice in a week. The duration of exposure to the photolamp will be 10 minutes to each part with all precautions. (If it covers in single slot the duration will be only 3-10 minutes). Group II will received UNIM 001 Placebo UNIM 003 NB-UVB phototherapy similar to Group I. Group-III will receive UNIM 001 UNIM 003 Placebo phototherapy similar to Group I. All the parameters will be recorded at baseline fortnightly on day 15th 30th 45th day 60th day 75th day and at the end of treatment protocol 90th days. On every follow up percent of repigmentation as well as any change has to be recorded in the CRF. Digital photographs of the affected region or depigmented part will be taken at an interval of 15 days during 3 months of treatment protocol. Total seven photograph will be taken during the treatment of affected parts. In case of any hypersensitivity from the exposure or the test drug the duration of exposure will be adjusted accordingly. |
| Comparator Agent |
UNIM 001 placebo
UNIM 003 placebo
NB UVB therapy |
Group II will received UNIM 001 Placebo UNIM 003 NB-UVB phototherapy similar to Group I.
Group-III will receive UNIM 001 UNIM 003 Placebo phototherapy similar to Group I.
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with clinically diagnosed segmental and non-dermatomal vitiligo.
Subjects with 12 -60 years of age.
Either gender.
With any duration of disease, site, extension and distribution of lesions.
Willingness to give written informed consent form. |
|
| ExclusionCriteria |
| Details |
Subjects with active vitiligo treatment with other drugs/systems
Non-cooperative subjects.
H/o of drug or alcohol abuse, chronic smokers not willing to abstain from smoking during the study period.
Any clinically significant abnormality identified on physical examination or laboratory tests.
Subjects having any systemic disease and other skin diseases.
Subjects with known allergies.
Impaired Cardiac, Hepatic and Renal function.
History of malignancy.
Concomitant use of any other antioxidants.
History of hypersensitivity to any of the investigational drugs/herbal medicine.
Receiving any other investigational product within 4 weeks.
Any medical condition, where physician feels participation in the study could be detrimental to subjects well being.
Uncontrolled infection.
Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
State of immunity before and after treatment through cytokine analysis IFN gamma IL 10 IL 6, IL1beta and TNF alpha
State of oxidative stress before and after treatment through Lipid peroxidation superoxide dismutase nitric oxide catalase and reactive oxygen species.
State of Vitamin D in the baseline. |
To study and ensure the cosmetically acceptable repigmentation with 40 percent to 50 percent decrease in VASI Score To evaluate the overall safety toxicity acceptability of unani coded drugs. To evaluate the decrease in the treatment duration with the NB UVB Therapy. To study the state of immunity and oxidative stress in pre and post treatment cases along with the vitamin D at baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the state of immunity before and after treatment in cases of vitiligo Baras along with the NB UVB therapy through the biochemical markers eg Th1 through IFN gamma Th2 through IL 10 and Th 17 through IL-6 IL 1 beta and TNF alpha and inflammatory markers as IFN gamma and TNF alpha.
To evaluate the oxidative stress Lipid peroxidation superoxide dismutase nitric oxide catalase and reactive oxygen species
State of Vitamin D in the baseline of vitiligo cases. |
To study and ensure the cosmetically acceptable repigmentation with 40 percent to 50 percent decrease in VASI Score To evaluate the overall safety toxicity acceptability of unani coded drugs. To evaluate the decrease in the treatment duration with the NB UVB Therapy. To study the state of immunity and oxidative stress in pre and post treatment cases along with the vitamin D at baseline. |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
15/08/2025 |
| 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="3"
Months="0"
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
|
The test drugs are coded unani formulations are effective in our
previous studies. The time of treatment is approximately 8 months to 1 year. In
our pilot studies we have observed when these coded formulations are given
along with NB UVB therapy in a closed chamber the period of repigmentation of
the affected site are reduced to approx to one third.
In this study subject will be randomly divided into three
groups 20 patients in each and they will receives Test drug UNIM 001 UNIM 003
and its identical placebo along with the NB UVB therapy.
We are also looking for the intricate relationship between oxidative stress and autoimmune processes
in effective treatment for vitiligo.
We are also looking for levels
of vitamin D at the baseline to understand the health status of the enrolled patients.
The outcome of the results
will be based on observation Digital photography reduction in VASI VIDA
Repigmentation score through mexameter as RMI Relative Melanin Index. Along with
the improvement in the stress markers inflammatory markers and QoL of the enrolled patients. |