| CTRI Number |
CTRI/2024/10/075001 [Registered on: 09/10/2024] Trial Registered Prospectively |
| Last Modified On: |
01/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) [THERAPEUTIC] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Study to find out safety and efficacy of Unani drugs in Childhood Psoriasis |
|
Scientific Title of Study
|
A Clinical Study to evaluate the safety and efficacy of Unani Formulations in Childhood Psoriasis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hafsa Tariq |
| Designation |
PG Scholar |
| Affiliation |
Ajmal Khan Tibbiya College |
| Address |
Department of Amraz-e- Jild Wa Zohrawiya,Faculty of Unani Medicine, Aligarh Muslim University, Aligarh.
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
7455830302 |
| Fax |
|
| Email |
hafsa.tariq0544@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Mohammad Mohsin |
| Designation |
Associate 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 |
9412329198 |
| Fax |
|
| Email |
aqdas2005@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Hafsa Tariq |
| 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 |
7455830302 |
| Fax |
|
| Email |
hafsa.tariq0544@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Amraz-e- jild Wa Zohrawiya |
|
|
Primary Sponsor
|
| Name |
Department of Amraze Jild Wa Zohrawiya |
| Address |
Ajmal Khan Tibbiya College Faculty of Unani Medicine Aligarh Muslim University Aligarh.Uttar Pradesh. India |
| 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 |
| DrHafsa Tariq |
Ajmal Khan Tibbiya College and Hospital.l |
Department of Amraz-e- Jild Wa Zohrawiya, Dermatology OPD.
Aligarh
UTTAR PRADESH |
7455830302
hafsa.tariq0544@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE DEPARTMENT OF AMRAZ E JILD WA ZOHRAWIYA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L408||Other psoriasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Habb e Surkhbada, Paste of Sang e Jarahat and Murdaar Sang with Roghan e Babchi |
Habb e Surkhbada: 1-2 pill(s) twice daily orally and paste of Sang e Jarahat and Murdaar Sang with Roghan e Babchi topically twice daily,for a duration of 6 months. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1. PASI (Psoriasis Area and Severity Index) score more than 10
2. PGA (Physicians Global Assessment) score: 3–4.
3. BSA is more than 10%.
4. A clinically stable patient.
5. Patients up to 15 years of age.
6. Patients of either sex.
7. Patients are not on any concomitant therapy.
8. Patients who have left the treatment at least 2 months ago.
9. The patient or guardian agreed and signed the written consent proforma. |
|
| ExclusionCriteria |
| Details |
1. Doubtful cases of childhood psoriasis.
2. Childhood psoriasis with secondary infection.
3. Immunocompromised patients.
4. Patients above the age of 15 years. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in PASI SCORE, PGA SCORE, BSA involved |
Monthly assessment for 6 months +2 months follow up. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in itching erythema induration |
Monthly assessment for 6 months plus two months follow up |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
15/10/2024 |
| 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) |
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
|
To provide the safe and cost effective treatment of childhood psoriasis. Null hypothesis: There is no significant effect of the trial formulations on the patients before and after the study Alternate hypothesis: There is significant effect of the trial formulations on the patients before and after the study. |