| CTRI Number |
CTRI/2025/12/099736 [Registered on: 23/12/2025] Trial Registered Prospectively |
| Last Modified On: |
20/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Other |
|
Public Title of Study
|
A Study to Compare Lauq Nazli and Sharbat-e-Banafsha for Treating Allergic Rhinitis (Nazla Haar) |
|
Scientific Title of Study
|
Comparative Clinical Evaluation of Lauq Nazli vs Sharbat-e-Banafsha in the Management of Nazla Haar (Allergic Rhinitis):A Randomized clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Umme Kulsum Tanzeem |
| Designation |
PG Scholar |
| Affiliation |
State unani medical college |
| Address |
OPD No 6 Department of Amraze Ain Uzn Anf Halq Wa Asnan State Unani Medical College and Hospital Old GT Road Himmatganj Prayagraj
OPD No 6 Department of Amraze Ain Uzn Anf Halq Wa Asnan State Unani Medical College and Hospital Old GT Road Himmatganj Prayagraj
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
06388202718 |
| Fax |
|
| Email |
umme1996kuls@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Usamah Ahmad |
| Designation |
Reader |
| Affiliation |
State unani medical college |
| Address |
Department of Amraze Ain Uzn Anf Halq Wa Asnan State Unani Medical College and Hospital Old GT Road Himmatganj Prayagraj
Department of Amraze Ain Uzn Anf Halq Wa Asnan State Unani Medical College and Hospital Old GT Road Himmatganj Prayagraj
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
06388202718 |
| Fax |
|
| Email |
arogyaherbal@gmail..com |
|
Details of Contact Person
Public Query
|
| Name |
Umme Kulsum Tanzeem |
| Designation |
PG Scholar |
| Affiliation |
State unani medical college |
| Address |
Department of Amraze Ain uzn anf halq wa asnan opd no 6 State Unani Medical College and Hospital Old GT road Himmatganj prayagraj
Department of Amraze Ain uzn anf halq wa asnan opd no 6 State Unani Medical College and Hospital Old GT road Himmatganj prayagraj
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
06388202718 |
| Fax |
|
| Email |
umme1996kuls@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Unani Medical And Hospital |
|
|
Primary Sponsor
|
| Name |
State Unani Medical College and Hospital |
| Address |
Old GT road Himmatganj Prayagraj 211016, U.P. |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Umme Kulsum tanzeem |
STATE UNANI MEDICAL COLLEGE AND HOSPITAL |
OPD No 6 Department of Amraze Ain Uzn Anf Halq Wa Asnan State Unani Medical College and Hospital Old GT Road Himmatganj Prayagraj
Allahabad
UTTAR PRADESH |
06388202718
umme1996kuls@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J30||Vasomotor and allergic rhinitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lauq Nazli |
Lauq Nazli a Unani preparation in the form of lauq administered orally 5 gm twice daily with lukewarm water after meals for 21 days with weekly followup. |
| Comparator Agent |
Sharbat-e-banafsha |
Sharbt-e-banafsha is a unani syrup administered 24ml orally twice daily after meals for 21 days with weekly followup. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 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
- Nasal itching
2 Patients who will give consent and able to do followup. |
|
| ExclusionCriteria |
| Details |
1 Medical history of Diabetic, gastrointestinal disease, systemic illness like Hypertension.
2 Use of anti-biotic medication in the last 6 weeks.
3 Psychiatric or Neurological disease.
4 Patients suffering from congenital nasal abnormalities like Deviated Nasal Septum or perforation.
5 Perennial allergic rhinitis, chronic rhinosinusitis etc.
6 Patients had received systematically administered corticosteroids, antihistamine, decongestants or CAM therapy within 02 weeks before enrolment.
7 Pregnant and lactating women.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total Nasal Symptom Score |
At baseline
2nd week
4th week
6th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Rhinitis Quality of Life Questionnaire (RQLQ) |
At baseline
6th Week |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/01/2026 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [umme1996kuls@gmail.com].
- For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2027?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Allergic rhinitis (Nazla Haar) is a highly prevalent immunological disorder characterized by sneezing, watery nasal discharge, nasal blockage, itching and eye irritation. It significantly impairs the patient’s daily functioning and quality of life. Although modern medicine offers antihistamines and decongestants, these treatments may cause sedation, rebound congestion or other adverse effects. Unani medicine describes Nazla Haar as the descent of hot morbid matter (bukharat/fuzlat) from the brain toward the nose and throat and several classical formulations, including Lauq Nazli and Sharbat-e-Banafsha, have been traditionally used for its management. The present randomized, parallel-group, open-label clinical trial aims to evaluate and compare the efficacy and safety of Lauq Nazli and Sharbat-e-Banafsha in patients with Allergic Rhinitis. A total of 60 patients meeting ARIA-based inclusion criteria will be enrolled from the ENT OPD of State Unani Medical College & HAHRDM Hospital, Prayagraj and randomized equally into two groups. Group A will receive Lauq Nazli (5 g orally, twice daily) and Group B will receive Sharbat-e-Banafsha (24 ml twice daily), both for 21 days, with follow-ups on days 7, 14, 21 and a post-treatment assessment on Day 28. Efficacy will be measured using the Total Nasal Symptom Score (TNSS), Absolute Eosinophil Count and the Rhinitis Quality of Life Questionnaire (RQLQ). Safety assessment will include clinical examination and laboratory investigations. Data will be analyzed using intention-to-treat principles. This study is expected to generate scientific evidence on the comparative therapeutic potential of two widely used Unani formulations and may provide safe, effective and affordable treatment options for Allergic Rhinitis.
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