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CTRI Number  CTRI/2022/10/046562 [Registered on: 17/10/2022] Trial Registered Prospectively
Last Modified On: 18/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of a unani formulation in the treatment of Shara (hives) 
Scientific Title of Study   Scientific evaluation for the effect of a unani Pharmacopoeial compound "NUQU-E-UNNAB" in Shara (Urticaria)  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Uzma Khatoon 
Designation  MD Scholor 
Affiliation  Ajmal Khan Tibbiya College, AMU, Aligarh 
Address  Department of Ilmul Advia, Ajmal khan tibbiya college, AMU, Aligarh

Aligarh
UTTAR PRADESH
202002
India 
Phone  8279720808  
Fax    
Email  dr.uzmakhatoon@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Abdur Rauf 
Designation  Associate Professor and Chairman 
Affiliation  Ajmal Khan Tibbiya College, AMU, Aligarh 
Address  Department of Ilmul Advia, Ajmal khan tibbiya college, AMU, Aligarh

Aligarh
UTTAR PRADESH
202002
India 
Phone  9457357442  
Fax    
Email  abdurraufmd@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Uzma Khatoon 
Designation  MD Scholor 
Affiliation  Ajmal Khan Tibbiya College, AMU, Aligarh 
Address  Department of Ilmul Advia, Ajmal khan tibbiya college, AMU, Aligarh

Aligarh
UTTAR PRADESH
202002
India 
Phone  8279720808  
Fax    
Email  dr.uzmakhatoon@gmail.com  
 
Source of Monetary or Material Support  
Department of Ilmul Advia, Ajmal khan Tibbiya College, A.M.U, Aligarh 
 
Primary Sponsor  
Name  Department of Ilmul Advia 
Address  Ajmal khan Tibbiya College, A.M.U, Aligarh 
Type of Sponsor  Other [Department of Ilmul Advia, Ajmal khan Tibbiya College, A.M.U, Aligarh] 
 
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 
Uzma khatoon  Ajmal khan tibbiya hospital  OPD No. 3, Amraz-e-jild wa tazeeniyat, Ajmal khan tibbiya hospital, AMU, Aligarh
Aligarh
UTTAR PRADESH 
8279720808

dr.uzmakhatoon@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committee, AKTCH AMU  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  STANDARD DRUG  LEVOCETRIZINE 5mg HS for 6 weeks 
Intervention  UNANI PHARMACOPOEAL PREPARATION   Unnab-Zizyphus sativa-7 Fruit Aloo Bukhara-Prunus domestica 4 Fruit Kishneez-Coriandrum sativum- Fruit-7 gm Shahtra-Fumaria officinalis-Whole plant- 8gm in the form of infusion (khaisanda) along with Sikanjabeen sada 25 ml for 6 weeks  
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Clinically diagnosed patients of CU according to the 2018 EAACI/GA2LEN/EDF/WAO guideline
2. Patients willing to sign consent form for the study. 
 
ExclusionCriteria 
Details  1. Patients less than 14 and more than 60 years of age.
2. concomitant skin disease.
3. Patients suffering from any other systemic diseases, pregnant and lactating women.
4. unwillingness or inability to fulfil the protocol.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
DECLINE IN WHEALS EPISODES AND ITCHING INTENSITY  EVERY FORTNIGHT UPTO 6 WEEKS 
 
Secondary Outcome  
Outcome  TimePoints 
IMPROVEMENT IN OBJECTIVE PARAMETERS LIKE QoL QUESTIONNAIRE, UAS7 AND BLOOD REPORTS   BEFORE AND AFTER STUDY  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="70" 
Phase of Trial   N/A 
Date of First Enrollment (India)   17/10/2022 
Date of Study Completion (India) 25/07/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

SCIENTIFIC EVALUATION FOR THE EFFECT OF A UNANI PHARMACOPEIAL PREPARATION "NUQU-E-UNNAB" IN SHARA (URTICARIA)

Urticaria is a vascular reaction of the skin characterized by the appearance of wheals generally surrounded by a red Hals or flare and associated with severe itching, stinging or pricking sensation.

The actual cause of Shara (Urticaria) is believed to be the Fasad-e-Dam (blood impairment) caused by the vapours of Dam-e-Merari (bilious blood) or Balgham-e-Boraqi (acidic phlegm) coming towards the skin or periphery of the body. 

Need of the study

1. CSU is a highly prevalent disease, It has a great impact on general population representing a burden for national health system due to its variability and yet unknown pathogenesis.

2. CSU significantly impairs the quality of life. The lack of clinical and laboratory biomarkers able to define the severity and prognosis usually leads to frustration of patients as well as of physicians. 

3.  Moreover, CSU has a variable rate of response to the approved newest therapies. The therapeutic approach of chronic urticaria aims at symptom relief. Licensed doses (1 tablet daily) of modern second-generation antihistamines are the first line treatment. Levocetirizine is second generation histamine antagonist and it has high affinity and selectivity for H1 receptor. The response rates to current third line treatment like cyclosporine and Omalizumab are each close to 75% but omalizumab is expensive and not reimbursed worldwide while Cyclosporin A has a high incidence of adverse effects. For leukotriene receptor antagonists, the level of evidence for efficacy is low. 

4.  In a retrospective analysis on the clinical and demographic information of patients with CSU, Sánchez Borges et al. reported that Anti Histaminic resistant-CSU was more frequent among Hispanic female patients (aged 14 to 60 years) and usually associated with other clinical indicators of severity such as atopic asthma, rhinosinusitis, hypertension, and thyroid disease.

WHO reports indicate that around 80%of the global population still relies on botanical drugs and several herbal medicines have been advanced to clinical use in modern medicine (Mahmood Z A et.al 2010). 

 Unani System of Medicine possesses many drugs that are highly effective for the treatment of skin diseases caused by imbalance in akhlat. Going through the literatures it is found that many single and compound formulations have been described for these purposes in various pharmacopoeias. One such nuskha is taken from "QARABADEEN QADRI" by Hm. Akbar Arzani, CHAPTER 20, PAGE NO. 475 matba munshi nawil Kishore Lucknow press. In the recent study Nuqu-e-unnab has been proposed to carry out its efficacy in shara through preclinical as well as clinical subjects.

 
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