| 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
|
|
|
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
|
|
|
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. |