| 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
|
|
|
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
|
|
|
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. |