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CTRI Number  CTRI/2025/09/094941 [Registered on: 16/09/2025] Trial Registered Prospectively
Last Modified On: 16/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Therapeutic Evaluation of Polyherbal Formulation along with Olive oil in the Management of Chronic Urticaria. 
Scientific Title of Study   Therapeutic and Safety Evaluation of A Compound Unani Formulation along with Roghan e Zaitoon in the Management of Shara (Chronic Urticaria) A Randomized open label Comparative clinical study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Asma Md Abid 
Designation  PG Scholar 
Affiliation  Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital 
Address  Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus kolar bypass road Bhopal Madhya Pradesh
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus kolar bypass road Bhopal Madhya Pradesh 462003
Bhopal
MADHYA PRADESH
462003
India 
Phone  08889279899  
Fax    
Email  dr.asmakhan56789@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Dilshad Ali 
Designation  Associate Professor  
Affiliation  Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital 
Address  Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus kolar bypass road Bhopal Madhya Pradesh
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus kolar bypass road Bhopal Madhya Pradesh 462003
Bhopal
MADHYA PRADESH
462003
India 
Phone  831976821  
Fax    
Email  dilshadali28@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Asma Md Abid 
Designation  PG Scholar 
Affiliation  Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital 
Address  Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus kolar bypass road Bhopal Madhya Pradesh
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus kolar bypass road Bhopal Madhya Pradesh 462003
Bhopal
MADHYA PRADESH
462003
India 
Phone  08889279899  
Fax    
Email  dr.asmakhan56789@gmail.com  
 
Source of Monetary or Material Support  
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Bhopal 462003 Madhya Pradesh Medical Science University Jabalpur 482003 Madhya Pradesh India 
 
Primary Sponsor  
Name  Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Bhopal 
Address  Hakim Syed Ziaul Hasna Government Unani Medical College and Hospital Ayush Campus kolar bypass road Bhopal Madhya Pradesh 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Asma Md Abid  Hakim Syed Ziaul Hasna Government Unani Medical College and Hospital  OPD No. 05 Department of Amraz e Jild wa Tazeeniyat of Hakim Syed Ziaul Hasan Government Autonomous Unani Medical College and Hospital Bhopal.
Bhopal
MADHYA PRADESH 
08889279899

dr.asmakhan56789@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L50||Urticaria,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Compound Unani Formulation following ingredients 1.Faudanj (Mentha arvensis linn) 7gm 2. Tabasheer (Bambusa arundinac ea linn)3.5gm 3.Gule Surkh (Rosa domascen a mill) 1.75gm 4. Kafoor (Cinnamomum camphora linn) 0.25gm Orally and Roghan-e-Zaitoon locally   6.125gm safoof of Compound Unani Formulation orally two times a day after meal along with Roghan-e-Zaitoon 10-12 drop for local application once a day after taking bath for 28 days. 
Comparator Agent  Roghan e Zaitoon.   Roghan e Zaitoon 10-12 drop for local application once a day after taking bath for 28 days.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Clinically Diagnosed patients of Chronic Urticaria.
2. Mild to moderate grade as defined by the Urticaria activity score (UAS7)
3. Patient who are willing and able to comply with scheduled visit and treatment plan, laboratory testing. and other study procedure.  
 
ExclusionCriteria 
Details  1. Patients having any cardiac, renal, and or hepatic insufficiency.
2. Patient with current diagnosis of active skin disease e.g. psoriasis, lupus
erythematosus Allergic dermatoses, eczema etc.
3. Pregnant and lactating women.
4. Patient unwilling to cooperate with the study protocol.
5. Patient taking either systemic or local corticosteroid.
 
 
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 
Urticaria Activity Score (UAS7)  On Day 0,7,14,21 and 28. 
 
Secondary Outcome  
Outcome  TimePoints 
DLQI (Dermatology life quality index)  On Day 0 and 28. 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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)   27/09/2025 
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="1"
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  

Allergic diseases such as urticaria pose a major challenge in terms of diagnosis and management. Urticaria significantly affects the quality of life and is marked by wheals, redness, and itching. Acute urticaria lasts less than six weeks, while chronic urticaria persists longer, commonly affecting middle aged women. Though mast cell activation and histamine release are recognized mechanisms, the exact cause remains unclear. Modern medicine provides symptomatic relief with antihistamines, corticosteroids, and leukotriene antagonists, but these are costly, associated with side effects like drowsiness, headache, and systemic complications, and do not offer a permanent cure.

In Unani medicine, urticaria is described as Shara, attributed mainly to fasad e dam due to excess bile or abnormal phlegm. Various single and compound formulations are traditionally used with good safety and effectiveness. To evaluate this approach, a clinical study was designed using a compound Unani formulation and Roghan e Zaitoon.

The compound formulation will be administered orally in a dose of 6.125 g twice daily after meals. It consists of Faudanj (Mentha arvensis, 7 g), Tabasheer (Bambusa arundinacea, 3.5 g), Gule Surkh (Rosa damascena, 1.75 g), and Kafoor (Cinnamomum camphora, 0.25 g). Roghan e Zaitoon will be applied locally once daily after bathing. Patients will be divided into groups: one receiving both the oral compound and local application, and the other receiving Roghan e Zaitoon alone. Levocetirizine 5 mg SOS will be permitted for unbearable symptoms, and the number of tablets consumed per week will be recorded in case report forms for evaluation.

 
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