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CTRI Number  CTRI/2025/08/092623 [Registered on: 07/08/2025] Trial Registered Prospectively
Last Modified On: 07/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Single Arm Study 
Public Title of Study   Unani Treatment for Allergic rhinitis with oral formulation and nasal drop 
Scientific Title of Study   To Evaluate The Efficacy of oral Unani formulation and Rogan Banafsha as Qatur-i-Anf(Nasal Drop) in Nazla Harr(Allergic Rhinitis):An Open Label Interventional Study 
Trial Acronym  AR 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nurain Siddiqi 
Designation  PG Scholar 
Affiliation  State Unani Medical College himmatganj Prayagraj Uttar Pradesh 211016 
Address  Department of Amraz e Ain Uzn Anf Halaq wa Asnan State Unani Medical College and HAHRDM Hospital Himmatganj Prayagraj

Allahabad
UTTAR PRADESH
211016
India 
Phone  7985963633  
Fax    
Email  sheikhnoor0901@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Mohd Asif Hussain Usmani  
Designation  Professor 
Affiliation  State Unani Medical College Himmatganj Prayagraj Uttar Pradesh 211016 
Address  Department of Amraz e Ain Uzn Anf Halaq wa Asnan State Unani Medical College and HAHRDM Hospital Himmatganj Prayagraj

Allahabad
UTTAR PRADESH
211016
India 
Phone  7905831926  
Fax    
Email  asifhussainusmani@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Nurain Siddiqi 
Designation  PG Scholar 
Affiliation  State Unani Medical College Himmatganj Prayagraj Uttar Pradesh 211016 
Address  Department of Amraz e Ain Uzn Anf Halaq wa Asnan State Unani Medical College and HAHRDM Hospital Himmatganj Prayagraj

Allahabad
UTTAR PRADESH
211016
India 
Phone  7985963633  
Fax    
Email  sheikhnoor0901@gmail.com  
 
Source of Monetary or Material Support  
State Unani Medical College Himmatganj Prayagraj Uttar Pradesh 211016 
 
Primary Sponsor  
Name  State Unani Medical College and HAHRDM Hospital Himmatganj Prayagraj 
Address  State Unani Medical College and HAHRDM Hospital Himmatganj Prayagraj UTTAR PRADESH 211016 
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 Nurain Siddiqi  State Unani Medical College and HAHRDM Hospital  OPD NO 6 Department of Amraz-e-Ain Uzn Anf Halaq wa Asnan GROUND FLOOR State Unani Medical College Himmatganj Prayagraj 211016
Allahabad
UTTAR PRADESH 
07985963633

sheikhnoor0901@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee(IEC) for Biomedical Research  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 
Comparator Agent  NIL  NIL 
Intervention  ORAL UNANI FORMULATION(JOSHANDA) AND ROGHAN BANAFSHA AS QATUR-I-ANF(NASAL DROP)  ORAL UNANI FORMULATION(JOSHANDA) WILL BE GIVEN 50 ML TWICE A DAY AND QATUR-I-ANF(NASAL DROP) WILL BE GIVEN 3-4 DROPS TWICE A DAY FOR 3 WEEKS 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Symptoms persisted for more than 4 days per week or more than 4 weeks per year and at least one of the following rhinitis-associated conditions: nasal congestion, rhinorrhea sneezing and nasal itching.
Patients who will give consent and able to do follow up 
 
ExclusionCriteria 
Details  Patients below 18 and above 60 years.
Patients suffering from systemic illness like Hypertension, Diabetes Mellitus, Malignancy,Liver or kidney dysfunction.
Patients suffering from congenital nasal abnormalities like nasal dermoid cysts, Deviated Nasal Septum, Atrophic rhinitis, Sinusitis, Hypertrophic turbinates, Adenoidal hypertrophy, foreign bodies.
Patients had received systematically administered corticosteroids, antihistamines, decongestants or CAM therapy within 02 weeks prior to enrolment.
Pregnant and lactating women. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Serum IgE
Symptom Severity Score 
7th,14th,21st day from baseline
 
 
Secondary Outcome  
Outcome  TimePoints 
Japanese Rhino-conjunctivitis Quality of Life Questionnaire  7th,14th,21st,28th day from baseline 
 
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)   25/08/2025 
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  

The study titled To Evaluate the Efficacy of Oral Unani Formulation and Roghan Banafsha as Qatur i Anf Nasal Drop in Nazla Harr Allergic Rhinitis An Open Label Interventional Study aims to scientifically assess the effectiveness and safety of traditional Unani medicine in the management of allergic rhinitis. Allergic rhinitis referred to as Nazla Harr in Unani literature is an IgE mediated condition that presents with symptoms such as sneezing nasal congestion watery nasal discharge and itching. It is a widespread condition that significantly impacts the quality of life and work performance of affected individuals. Although modern medicine offers various treatment options these often come with side effects such as drowsiness and impaired psychomotor function.

In this open label single arm interventional trial 40 patients aged between 18 and 60 years with clinically diagnosed allergic rhinitis will be selected from the OPD of State Unani Medical College and HAHRDM Hospital Prayagraj. The intervention consists of a polyherbal Unani decoction Joshanda made from Gule Banafsha Unnab Sapistan Tukhm Khatmi and Misri administered orally along with Roghan Banafsha used as a nasal drop Qatur i Anf. The treatment will be given for three weeks with weekly follow ups followed by a post treatment assessment in the fourth week.

The study will evaluate efficacy based on subjective parameters like nasal discharge sneezing nasal congestion nasal itching and eye irritation and objective measures such as serum IgE levels and symptom severity scores. Safety will be monitored through clinical examination and laboratory investigations. This research is designed to validate the traditional Unani approach and offer a low cost accessible and safe alternative to conventional therapies for allergic rhinitis.

 
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