| CTRI Number |
CTRI/2024/07/071481 [Registered on: 29/07/2024] Trial Registered Prospectively |
| Last Modified On: |
28/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani
Other (Specify) [Therapeutic] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing Unani medicine and Autologous Serum Therapy for treating chronic urticaria |
|
Scientific Title of Study
|
An Open Label, Randomized Clinical Trial of Unani Formulation and Autologous Serum Therapy (AST) in the management of
Shara-e-Muzmin (Chronic Urticaria) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yusra Tanveer |
| Designation |
PG SCHOLAR |
| Affiliation |
Department of Amraze Jild Wa Zohrawiya, Faculty of Unani Medicine |
| Address |
Department of Amraze Jild Wa Zohrawiya, Ajmal Khan Tibbiya College, AMU, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8279398787 |
| Fax |
|
| Email |
yusratanveer225@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Zamir Ahmed |
| Designation |
Professor |
| Affiliation |
Department of Amraze Jild Wa Zohrawiya, Faculty of Unani Medicine |
| Address |
Department of Amraze Jild Wa Zohrawiya, Ajmal Khan Tibbiya College, AMU, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8475007594 |
| Fax |
|
| Email |
drzamiramrohi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yusra Tanveer |
| Designation |
PG Scholar |
| Affiliation |
Department of Amraze Jild Wa Zohrawiya, Faculty of Unani Medicine |
| Address |
Department of Amraze Jild Wa Zohrawiya, Ajmal Khan Tibbiya College, AMU, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8279398787 |
| Fax |
|
| Email |
yusratanveer225@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Amraze Jild wa Zohrawiya, Faculty of Unani Medicine, AMU, Aligarh, UP, India, 202001 |
|
|
Primary Sponsor
|
| Name |
Department of Amraze Jild wa Zohrawiya Ajmal Khan Tibbiya College and Hospital AMU Aligarh |
| Address |
Faculty of Unani Medicine, Aligarh Muslim University Aligarh |
| 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 |
| Dr Yusra Tanveer |
Ajmal Khan Tibbiya College , AMU, Aligarh |
Department of Amraze Jild Wa Zohrawiya, Ajmal Khan Tibbiya College Aligarh Muslim University Aligarh
Aligarh
UTTAR PRADESH |
8279398787
yusratanveer225@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: L509||Urticaria, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Autologous Serum Therapy (AST) |
Patients of group II will be given Autologous serum therapy weekly for 6 weeks |
| Intervention |
Qurse Kafoor and Sharbate Nilofar |
Patients of group I will be given 1 tablet of Qurse Kafoor twice daily with Sharbate Nilofar 20ml twice daily orally for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
• Clinically diagnosed patients of Chronic Urticaria (Urticaria of more than 6 weeks); with clinical features of erythema, itching and wheals of any grade.
• Patients of either sex in the age group of 18 years onwards.
• Patients who have agreed to sign the written informed consent and follow the protocol.
|
|
| ExclusionCriteria |
| Details |
• Patients with other skin diseases like psoriasis, eczema, etc. by history and examination.
• Patients of urticaria presenting with features of angioedema.
• Patients suffering from any other systemic diseases, such as HTN, DM, IHD, HIV, and bronchial asthma will be excluded on the basis of history and examination.
• Pregnant and lactating women.
• Patient already taking modern medicine or will be included in the study after a washout period of 2 weeks.
• In case of worsening of the symptoms, the patient will be shifted to the standard management.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
UAS7- Weekly urticaria activity score[5,11]-
• Itching- 0: None, 1: Mild (no discomfort), 2: Moderate (annoying but no impact on daily activities, sleep), 3: Intense (severe itching, interferes daily activities and sleep).
• Wheals- 0: No wheals, 1: Mild (less than 20 wheals per 24 hours),
2: Moderate (20-50 wheals per 24 hours), 3: Intense (more than 50 wheals per 24 hours) or large confluent areas of wheals.
|
weekly for six weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
CUQ2OL- Chronic urticaria quality of life questionnaire[8,9,12]-
• Quality of life of the patient- It contains 23 questions, with scores from 1 (no complaints) to 5 (many complaints). Scores ≥ 3 are considered as poor quality of life. |
weekly for six weeks |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
10/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/08/2024 |
| 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 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
|
AIMS AND OBJECTIVES-
To evaluate the safety of Unani herbal formulation of Qurse Kafoor and Sharbate Nilofar in the management of Chronic Urticaria To evaluate the efficacy of Unani herbal formulation of Qurse Kafoor and Sharbate Nilofar in the management of Chronic Urticaria. |