| CTRI Number |
CTRI/2024/04/065215 [Registered on: 04/04/2024] Trial Registered Prospectively |
| Last Modified On: |
26/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical study to evaluate the safety and efficacy of Safūf Baraṣ in Baraṣ (Vitiligo) |
|
Scientific Title of Study
|
A Randomized, Parallel Group, Open Label, Active
Controlled Clinical Study to evaluate the Safety and
Efficacy of Safūf Baraṣ compared with Methoxsalen
in the Management of Baraá¹£ (Vitiligo) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 38-18/2023-24/NRIUMSD/Acad/IEC/01 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR MOHD TARIQUE |
| Designation |
PG SCHOLAR |
| Affiliation |
|
| Address |
DEPARTMENT OF MOALAJAT, NATIONAL RESEARCH INSTITUTE OF UNANI MEDICINE FOR SKIN DISORDERS, HYDERABAD
Hyderabad
TELANGANA
500038
India |
| Phone |
8237937202 |
| Fax |
|
| Email |
drtariquemohd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PROF QAMAR UDDIN |
| Designation |
PROFESSOR |
| Affiliation |
|
| Address |
DEPARTMENT OF MOALAJAT, NATIONAL RESEARCH INSTITUTE OF UNANI MEDICINE FOR SKIN DISORDERS, HYDERABAD
Hyderabad
TELANGANA
500038
India |
| Phone |
8700027178 |
| Fax |
|
| Email |
qamaruddindr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MOHD TARIQUE |
| Designation |
PG SCHOLAR |
| Affiliation |
|
| Address |
DEPARTMENT OF MOALAJAT, NATIONAL RESEARCH INSTITUTE OF UNANI MEDICINE FOR SKIN DISORDERS, HYDERABAD
Hyderabad
TELANGANA
500038
India |
| Phone |
8700027178 |
| Fax |
|
| Email |
drtariquemohd@gmail.com |
|
|
Source of Monetary or Material Support
|
| NATIONAL RESEARCH INSTITUTE OF UNANI MEDICINE FOR SKIN DISORDERS |
|
|
Primary Sponsor
|
| Name |
NATIONAL RESEARCH INSTITUTE OF UNANI MEDICINE FOR SKIN DISORDERS |
| Address |
AG COLONY ROAD, OPP. ESI HOSPITAL, ERRAGADDA, HYDERABAD 500038 |
| 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 MOHD TARIQUE |
NATIONAL RESEARCH INSTITUTE OF UNANI MEDICINE FOR SKIN DISORDERS |
OPD & IPD OF DEPARTMENT OF MOALAJAT, NATIONAL RESEARCH INSTITUTE OF UNANI MEDICINE FOR SKIN DISORDERS
Hyderabad
TELANGANA |
8237937202
drtariquemohd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| COMMUNICATION OF DISSERTATION OF INSTITUTIONAL ETHICS COMMITTEE (IEC) |
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 |
| Comparator Agent |
1.Oral Methoxsalen (Tablet 10 mg)
2.Topical Methoxsalen (1% Solution) |
1. Tablet will be given once daily on alternate days in the dose of 20-40 mg orally with water after meals, 1-2 hours before exposure to sunlight.
2. Patients will be advised to carefully apply Methoxsalen
(1%) solution topically on vitiliginous lesions, 1-2 hours after oral dose of
Methoxsalen in the morning followed by sun exposure. |
| Intervention |
SAFŪF BARAṢ
|
SAFŪF BARAá¹¢ (Containing Post-i-Katomari,Pos-i-NÄ«m,ChÄksÅ«,Tukhm PanwÄr and BÄbchÄ«) will be used both internally as a ZulÄl (Decanted water) and externally as a Sufl (Sediment remained after decanting the
soaked drug) in the form of ḌimÄd (Paste) once daily.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
The following patients will be included in the study:
1.Patients of any sex aged 18-60 years
2.Non-Segmental Vitiligo with Chronicity of 6
months to 2 years
3.Vitiligo involving more than 2% Body Surface Area (BSA)
4.Patients with less than 5 New Lesions in the last month
5.Patients with less than 15 lesions in the last 3 months
6.Patients who have not received systemic treatment within 4 weeks prior to study entry
7.Patients who have not received topical
treatment within 2 weeks prior to study entry |
|
| ExclusionCriteria |
| Details |
The following patients will be excluded: 1.Patients aged less than 18 years or more than 60 years
2. Segmental Vitiligo/ Lip-Tip Vitiligo/ Universal Vitiligo/ Vitiligo with Leucotrichia
3. Significant Pulmonary/ Cardiovascular/ Hepatorenal Dysfunction, and other Disorders requiring long-term treatment
4. Known cases of Immunocompromised states (HIV/ AIDS, etc.)/ Malignancies
5. Pregnant or Lactating Women Patient not willing to attend treatment schedule regularly |
|
|
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 |
Reduction in Vitiligo Area Scoring Index (VASI)
|
0,2,4 and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Vitiligo Impact Scale-22 (VIS-
(Assessment of Patient’s Quality of Life)
2. Improvement in Patient’s Global Assessment (PGA) on VAS
3. Improvement in Investigators Global Assessment (IGA) |
0 and 8 weeks |
|
|
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)
|
01/10/2024 |
| 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) |
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
|
Baraṣ (Vitiligo) is marked by milky, white, depigmented. It has a very prominent social and psychological impact on the patients, with prevalence of 3-4% in India. The available treatment in modern medicine, including psoralens, corticosteroids, skin grafting and Monobenzyl ether, have their own limitations numerous adverse effects. In Unani medicine, various single and compound drugs are effectively used in the treatment of vitiligo, but these drugs need to be evaluated on scientific parameters. Keeping this in view, the present clinical study has been designed to evaluate the safety and efficacy of Safūf Baraṣ in the Management of Baraṣ (Vitiligo). |