| CTRI Number |
CTRI/2025/09/094651 [Registered on: 12/09/2025] Trial Registered Prospectively |
| Last Modified On: |
11/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Unani Other (Specify) [therapeutic] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Unani treatment for hives or skin allergy |
|
Scientific Title of Study
|
Efficacy of Zulaal-e-Tamarhindi orally along with Arad Jau and Sirka vs Roghan Gul and Sirka topically in Shara (Urticaria)- A Comparative Clinical Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rumana Shabnum |
| Designation |
PG Scholar |
| Affiliation |
Government Unani Medical College and Hospital |
| Address |
Dept of Amraze Jild wa Tazeeniyat Room no 8
Government Unani Medical College and Hospital
Dr Siddaiah Puranik Road, Basaveshwaranagar, Bengaluru 79
Dept of Amraze Jild wa Tazeeniyat
Government Unani Medical College and Hospital
Dr Siddaiah Puranik Road, Basaveshwaranagar. Bengaluru 79.
Bangalore KARNATAKA 560079 India |
| Phone |
9538921772 |
| Fax |
|
| Email |
rumanashabnum469@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof Ayesha Tabasum |
| Designation |
Professor and HOD |
| Affiliation |
Government Unani Medical College and Hospital |
| Address |
Dept of Amraze Jild wa Tazeeniyat Room number 8
Government Unani Medical College and Hospital
Dr Siddaiah Puranik Road, Basaveshwaranagar, Bengaluru 79
Bangalore KARNATAKA 560079 India |
| Phone |
9035158024 |
| Fax |
|
| Email |
ayesharafeeq81@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Prof Ayesha Tabasum |
| Designation |
Professor and HOD |
| Affiliation |
Government Unani Medical College and Hospital |
| Address |
Dept of Amraze Jild wa Tazeeniyat Room number 8
Government Unani Medical College and Hospital
Dr Siddaiah Puranik Road, Basaveshwaranagar, Bengaluru 79
Bangalore KARNATAKA 560079 India |
| Phone |
9035158024 |
| Fax |
|
| Email |
ayesharafeeq81@yahoo.com |
|
|
Source of Monetary or Material Support
|
| OPD 8 ,Government Unani Medical College and Hospital, Bengaluru 560079 |
|
|
Primary Sponsor
|
| Name |
Government Unani Medical College and hospital |
| Address |
Dr Siddaiah Puranik Road, Basaveshwaranagar, Bengaluru 79
|
| 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 Rumana Shabnum |
Government Unani Medical College and Hospital |
OPD 8,Department of Amraze jild wa Tazeeniyat,Government Unani Medical College and Hospital,
Dr Siddaiah Puranik Road, Basaveshwaranagar, Bengaluru 560079.
Bangalore KARNATAKA |
9538921772
rumanashabnum469@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) for Biomedical Research, Government Unani Medical College and Hospital |
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 |
Zulaal -e- Tamarhindi orally along with Roghan e Gul and sirka topically |
Zulaal is prepared by soaking 10grams of Tamarhindi in 50ml of water overnight and then water is decanted gently and administered orally before breakfast daily for 30days
Required quantity of Roghan gul will be mixed with Sirka in the ratio 2 is to 1
Clean the affected area and apply the required quantity over the lesions daily at night for 30days and washed in morning
|
| Intervention |
Zulaal -e-Tamarhindi orally
Arad Jau and Sirka topically |
Zulaal is prepared by soaking 10grams of Tamarhindi in 50ml of water overnight and then water is decanted gently and administered orally before breakfast daily for 30days
Required quantity of Jau will be powdered and mixed with Sirka in the ratio of 2 : 1
Clean the affected area and apply the required quantity of latukh epithem over the lesions daily at night for 30days and washed in morning
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients of all gender between the age group 18 to 50 years.
Clinically diagnosed cases of mild less than 20 wheals to moderate (20 to 50 wheals) Chronic Urticaria,
Patients who are willing to sign the consent form for the trial.
|
|
| ExclusionCriteria |
| Details |
Uncontrolled DM RBS greater than 200mg per dl
Hypertension Renal impairment skin infections and any malignancy
Immunocompromised patients,
History of treatment for Chronic Urticaria in past
1 month,
Patients suffering from skin infections other pigmentary and inflammatory skin diseases
Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Decrease in CRP and ESR levels.
2.Changes in UAS7 Score.
|
1.Decrease in CRP and ESR levels on 0th and 28th day.
2.Changes in UAS7 Score on 7th 14th 21st 28th day.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Improvement in Subjective parameters
2 Reduction in CUQ2OL Score
|
1 Improvement in Subjective parameters on 7th 14th 21st and 28th day
2 Reduction in CUQ2OL Score on 7th 14th 21st and 28th day
|
|
|
Target Sample Size
|
Total Sample Size="34" Sample Size from India="30"
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)
|
15/11/2025 |
| 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="6" 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
|
Shara (Urticaria) is a vascular reaction of the skin characterized by the appearance of wheals, generally surrounded by red flare and associated with severe itching, stinging or pricking sensation. The term Urticaria is derived from Latin word urtica and urere, which means nettle and to burn It is commonly called as hives. Urticaria which lasts for more than 6 to 8 weeks duration is called Chronic Urticaria (CU). CU is a common dermatological condition affecting an estimated 15 to 20percent of the general population at least once during lifetime. Females are nearly twice as frequently affected as males and the peak incidence of chronic Urticaria falls between 20-40years of age. The global age standardized prevalence incidence and DALY (Daily Adjusted Life year) rates of Urticaria showed marginal changes In 2019 65.14 million individuals were affected with a prevalence rate of 841.88per 100000 population.The DALY rate was 50.39 per 100 000 population. Nationally,Urticaria prevelance in 2019 varied dramatically, from a low of 27.1 per 100000 population in Portugal to a high of 92.0 per 100000 population in Nepal India reported most DALYS at 749495.9followed by China, Pakistan and United states. Clinical features of Shara are recurrent skin eruptions heat and pricking sensation followed by appearance of lesions. It is also characterized by edematous wheals surrounded by red flare intense itching with burning sensation which usually increases in the evening. In conventional medicine Antihistamines of theH1 receptor blocker such as Promethazine, Diphenhydramine, Fexofenadine, Astemizole, Cetrizine, Loratidine are effective and H2 antagonist such as Cimetidine and intravenous hydrocortisone are available for the management of Chronic Urticaria. But these drugs exert adverse effect like hepatotoxicity, cardiotoxicity, sedative effects anticholinergic effects etc.. There is a need for Alternative system of medicine in the treatment of Shara as it may have comparatively less side effects and has more potent effects. According to Unani concept the cause of Shara is Fasad e dam ( impairment of blood)- caused by the vapors of Dam e mirari( bilious blood) or Balgham e Boraqi (acidic phlegm) coming towards the skin or periphery of the body. Principles of treatment of Shara includes removal of the underlying cause use of Musaffi e dam advias (Blood purifiers) and antiallergic drugs. The Unani physicians recommended both single and compound formulations for the management of Urticaria. Single drugs like Doob, Jau ,Tabasheer, Tamarhindi, Aloo Bukhara, Sirka, kafoor, Rose, Ajwain, Geru, Isapgol, etc ...Compound drugs like Roghan e gul, Arq e gulab, Qurs e tabasheer, sikanjabeen, Joshanda e halela, Qurs e kafoor, Ma ul jubn, etc.. These drugs possess properties like Musakkin e meda,Musakkin e hararath (Soothing agent )Mudir e Baul( diuretic) Jali (detergent) Muhalllil (Resolvant) Qabis (Astringent )Mujaffif (Desiccant) However, these drugs have not been scientifically explored so far. Hence, Zulaal Tamarhindi orally, along with Arad Jau Barley powder and Sirka Vinegar vs Roghan gul (Rose oil) with Sirka (vinegar) topically is designed to provide safe, more effective and economical treatment for Shara( Urticaria). |