CTRI Number |
CTRI/2023/03/050278 [Registered on: 02/03/2023] Trial Registered Prospectively |
Last Modified On: |
28/02/2023 |
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
|
Randomized, Clinical Study to Evaluate the Efficacy and Safety of Roghan-i-Baras in management of Baras(Vitiligo) |
Scientific Title of Study
|
A Randomized, Parallel group, Open Label, Active controlled Clinical study to Evaluate the Efficacy and Safety of Roghan-i-Baras in the management of Baras (Vitiligo) |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Mohd Ashik |
Designation |
PG Scholar |
Affiliation |
National Research Institute Of Unani Medicine For Skin Disorders |
Address |
Department Of Moalajat, National Research Institute Of Unani Medicine For Skin Disorders, A.G. Colony Road, Opp. ESI Hospital, Erragadda, Hyderabad-500038
India
Hyderabad TELANGANA 500038 India |
Phone |
9005370209 |
Fax |
|
Email |
ansariashiq891@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Prof Arzeena Jabeen |
Designation |
Professor |
Affiliation |
National Research Institute Of Unani Medicine For Skin Disorders |
Address |
Department Of Moalajat, National Research Institute Of Unani Medicine For Skin Disorders, A.G. Colony Road, Opp. ESI Hospital, Erragadda, Hyderabad-500038
India
Hyderabad TELANGANA 500038 India |
Phone |
9032519286 |
Fax |
|
Email |
aarzu763@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Mohd Ashik |
Designation |
PG Scholar |
Affiliation |
National Research Institute Of Unani Medicine For Skin Disorders |
Address |
Department Of Moalajat, National Research Institute Of Unani Medicine For Skin Disorders, A.G. Colony Road, Opp. ESI Hospital, Erragadda, Hyderabad-500038
India
Hyderabad TELANGANA 500038 India |
Phone |
9005370209 |
Fax |
|
Email |
ansariashiq891@gmail.com |
|
Source of Monetary or Material Support
|
National Research Institute Of Unani Medicine For Skin Disorders,AG colony road, Erragadda,Hyderabad |
|
Primary Sponsor
|
Name |
National Research Institute Of Unani Medicine For Skin Disorders |
Address |
A.G. Colony Road, Opposite 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 Ashik |
National Reasearch Institute Of Unani Medicine For skin Disorders |
OPD of Department of
Moalajat, New OPD
Block, National
Research Institute of
Unani Medicine for Skin
Disorders A G Colony
Road, Opposite ESI
Hospital, Erragadda,
Hyderabad 500038
Hyderabad
TELANGANA Hyderabad TELANGANA |
9005370209
ansariashiq891@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional ethical Committee, NRIUMSD, Hyderabad |
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 |
Methoxsalen 1% |
Dosage Form: Ointment
Dose: Applied locally As Per Required once in the morning
Duration: 16 weeks |
Intervention |
Roghan-i-Baras |
Dosage Form: Oil
Dose : To be applied locally as per required once in the morning
Duration: 16 weeks
Composition
1. Post Baikh
Sheetraj Hindi Plumbago zeylancia Linn. 10 gm
2. Tankar (Suhaga) Sodium borate (Decahydrate) 10 gm
3. Ghungchi safaid Abrus precatorius Linn. 10 gm
4. Roghan-e-kunjad Sesamum indicum Linn. 250 ml |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1.The participants will be included in the study on the basis of the following
criteria:
2.Subjects of any sex aged 18-60 years
3.Non-Segmental Vitiligo with Chronicity of 6 months to 3 years
4.Subjects with <5 new lesions in the last month, atleast 1% body surface
area.
5.Subjects with <15 lesions in the last 3 months, atleast 1% body surface
area.
6.Subjects who have not taken systemic treatment in the last 4 weeks
7.Subjects who have not taken topical treatment in the last 2 weeks
8.Participants who are able and willing to comply with the protocol and to sign IEC approved ICF |
|
ExclusionCriteria |
Details |
The following patients will be excluded
•Patients aged <18 years or >60 years
•Segmental Vitiligo/ Lip-Tip/ Universal Vitiligo
•History of photosensitivity/ photo exaggerated dermatoses and Connective Tissue Diseases
•Pregnant or Lactating Women
•Significant Cardiovascular/ Pulmonary/ Hepato-renal Dysfunction
•Known cases of Immunocompromised states (HIV/ AIDS, etc.)/ Malignancies (cutaneous or internal)
•Patients not willing to attend treatment schedule regularly
•Patients not having a suitable facility for sun exposure.
•Any other clinical condition that in the opinion of the investigator would compromise the patient’s safety or successful participation in the trial.
•Known allergy, sensitivity or intolerance to the study drug or any of its ingredients
•Participants with active alcohol intake and/or drug abuse
•Participants not willing to sign the ICF and 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 |
1.Reduction in Vitiligo Area Scoring Index (VASI)
2.Change in Vitiligo Disease Activity (VIDA) Score.
3.Improvement in Global Assessment (IGA)
4.Photographic Assessment |
4th,8th,12th and 16th week |
|
Secondary Outcome
|
Outcome |
TimePoints |
Systemic safety Assessment |
4th,8th,12th and 16th 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)
|
10/03/2023 |
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 Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
none yet. |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Vitiligo is a cosmetic dermatological defect, but it has a very prominent social and psychological impact on the patient. It is a depigmenting skin disorder characterized by the selective loss of melanocytes,
which in turn leads to pigment dilution in the affected
area of the skin. The
characteristic lesion is totally amelanotic, non-scaly, chalky-white macule
with distinct margins. Vitiligo is a common dermatological as well as cosmetic and social problem with prevalence 1% to 2% of
the world population .In India it is between 3% to 4%. The incidence of vitiligo
as reported by various workers
in different cities of India can
be 2.9% in Goa, 8.8% in Delhi. However most authors say that its incidence is around is 4% which is however
definitely more as compared to worlds population of 1%. Several single and compound formulations have been used to treat vitiligo by many ancient Unani physicians, but some of them are not yet scientifically evaluated on modern parameters. Hence, this A Randomized, Parallel Group, Open Label, Active Controlled Clinical
Study is planned to evaluate the Efficacy and Safety of Roghan-i-Baras in the Management of Baraá¹£ (Vitiligo). Participants fulfilling inclusion and exclusion criteria will receive either test or control drug as per randomization. In test group participants will start with Roghan-i-Baras and in control group participants will start with Methoxsalen 1% , for the duration of 16 weeks. Baseline and last follow up and laboratory investigations will be done. Statistical analysis : After completion of the study, data obtained
will be analysed statistically by using an appropriate statistical test to evaluate the significance of results. p<0.05
will be considered significant. |