| 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
|
|
|
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
|
|
|
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. |