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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  
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 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  
Status 
Not Applicable 
 
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).

 

 
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