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CTRI Number  CTRI/2023/10/058727 [Registered on: 17/10/2023] Trial Registered Prospectively
Last Modified On: 13/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   To Asses efficacy and safety of polyherbal unani formulation In Nazla 
Scientific Title of Study   Evaluation of efficacy and safety of polyherbal unani formulation in Nazla Haar (Allergic Rhinitis) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Zeba Khan Warsi  
Designation  Post Graduate Scholar  
Affiliation  State Unani Medical College  
Address  Department of Amraze Ain Uzn Anf Halaq wa Asnan, State Unani Medical College, Himmatganj, Prayagraj

Allahabad
UTTAR PRADESH
211016
India 
Phone  863002047837  
Fax    
Email  amberkhanwarsi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mohd Asif Hussain Usmani  
Designation  Head of Department and Professor  
Affiliation  State Unani Medical College  
Address  Department of Amraze Ain Uzn Anf Halaq wa Asnan, State Unani Medical College, Himmatganj, Prayagraj

Allahabad
UTTAR PRADESH
211016
India 
Phone  7905831926  
Fax    
Email  asifhussainusmani@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Usamah Ahmad  
Designation  Associate Professor  
Affiliation  State Unani Medical College , Himmatganj,Prayagraj2¹1 016 
Address  Department of Amraze Ain Uzn Anf Halaq wa Asnan, State Unani Medical College, Himmatganj,Prayagraj

Allahabad
UTTAR PRADESH
211016
India 
Phone  9415639877  
Fax    
Email  arogyaherbal@gmail.com  
 
Source of Monetary or Material Support  
State Unani Medical College Prayagraj, Ministry of AYUSH,U.P govt. 
 
Primary Sponsor  
Name  State Unani Medical College Himmatganj Prayagraj  
Address  Department of Amraze Ain Uzn Anf Halaq wa Asnan, State Unani Medical College Himmatganj Prayagraj 211016 India  
Type of Sponsor  Research institution and hospital 
 
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 Zeba Khan Warsi   OPD/IPD of Amraze Ain Uzn Anf Halaq wa Asnan,  OPD No.6, department of amraze Ain Uzn Anf Halaq wa Asnan, State Unani Medical College Himmatganj Prayagraj 211016
Allahabad
UTTAR PRADESH 		 8630020478

amberkhanwarsi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, State Unani Medical College, Prayagraj   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J309||Allergic rhinitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Decoction or Joshanda of Polyherbal Unani Formulation   Decoction of 3gm of Cydonia oblonga mill.(Bahidana),5 gm of Zizyphus vulgaris lau.(Unnab),6 gm of Cordia latifolia roxb(Sapistan),7gm of Althoea officinalis linn(Tukhm e khatmi),5 gm of Borago officinalis(Gauzaban).Dose of 20 ml twice daily will be consumed by the patient. 
Comparator Agent  NOT APPLICABLE   NIL 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Patient of any sex
2. Age group between 19 to 50 years
3. Patients clinically diagnosed with Nazla Haar(Allergic Rhinitis).
4. Patients with raised Total Eosinophil Count and Total Serum IgE. 
 
ExclusionCriteria 
Details  1. Age below 19 years and above 50 years.
2. Pregnancy and Lactation.
3. Patients with history of Comorbidities like Diabetes and Hypertension, Renal impairment, etc.
4.Patients with other disease of Nose. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.The level of Absolute Eosinophil Count and Non specific Serum IgE will be assessed by analysing the blood samples and result will be subjected to statistical analysis using paired t test.
2.The Total Nasal Symptoms Score (TNSS) will be used to assess the sum of score of the following symptoms, Nasal Congestion, Sneezing, Nasal itching, and Rhinorhoea at each time point, using four point scale (0-3). 		 Baseline, 1 and 2 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Other Allergic disorders like skin allergy may be assessed   0 and 3 weeks  
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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/ Phase 3 
Date of First Enrollment (India)   25/10/2023 
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 Yet Recruiting 
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 rhinitis (AR) is a significant public health, medical, and economic problem in developing
countries and AR is also an important risk factor for many diseases and disorders. The incidence of
AR has been on the rise in recent years and has a significant impact on the general public. This large
increase is alarming, and it is important to better understand the prevalence status and
characteristics, sensitization patterns, and associated risk factors for AR in order to improve
treatment and develop effective prevention strategies. It emphasizes the urgent need for
understanding 
. The study highlights the rising trend of allergic rhinitis and its impact on children
and adults simultaneously which in turn demand more focused studies to prevent allergic rhinitis.
In another study conducted on Indian rural population also pointed out the challenge to
otorhinolaryngologist even having facilities of advance treatment and diagnostic facilities in order
to treat the patients of allergic rhinitis 
. In the modern medical treatment numerous medications is
available. However, Self-medication is widespread and leads to both over- and under-medication.
Over medication is associated with numerous side effects that lead to unnecessary costs and
increased morbidity, while under medication leads to suboptimal symptom control that
compromises quality of life . The most effective treatment is intranasal corticosteroids till date 
.
Commonly available INCS are beclomethasone, triamcinolone, budesonide, fluticasone,
mometasone, and ciclesonide. INCS has been shown to improve nasal congestion and reduce sleep
disturbance and daytime sleepiness in patients. It aims to improve the quality of life during the day,
reduce fatigue and ultimately improve children’s school performance. However, dry nose, crusting
of mucous membranes, and bleeding are not uncommon. Other side effects of INCS include
transient symptoms such as nasal stinging, throat irritation, and even perforation of the nasal septum.
When it comes to the treatment of allergic rhinitis- It is a well-known fact that Continuous use of
anti-allergy and anti-inflammatory drugs always has many dangerous side effects. In order to
provide comprehensive approach to treat allergic rhinitis, Unani medicine, an alternative form of
treatment, comes forward with successful management of diseases and numerous historical
evidences available about the efficacy of Unani medicine in Nazla Haar (allegic rhinitis). These
drugs can be used for a long time without side effects. The Unani system offers a large number of
single and combination n drugs that can be administered to populations of different temperaments.
Keeping the above facts in view, it has been planned to conduct a clinical trial entitled "EVALUATION OF EFFICACY AND SAFETY OF POLYHERBAL UNANI
FORMULATION IN NAZLA HAAR (ALLERGIC RHINITIS)".
 
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