| CTRI Number |
CTRI/2025/08/092703 [Registered on: 08/08/2025] Trial Registered Prospectively |
| Last Modified On: |
08/08/2025 |
| 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
|
A Study Comparing Two Unani Herbal Remedies for Chronic Rhinosinusitis. |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Study Of Polyherbal Unani Formulation And Sharbat e Banafsha In The Management Of Waram Tajawif Al Anf Muzmin(Chronic Rhinosinusitis) |
| Trial Acronym |
CRS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Malik Nusrat Fatima |
| Designation |
PG Scholar |
| Affiliation |
State Unani Medical College Himmatganj Prayagraj Uttar Pradesh Pin Code 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 |
7060611241 |
| Fax |
|
| Email |
nusratmalik407@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mohd Asif Hussain Usmani |
| Designation |
Professor |
| Affiliation |
State Unani Medical College Himmatganj Prayagraj Uttar Pradesh Pin Code 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 |
Malik Nusrat Fatima |
| Designation |
PG Scholar |
| Affiliation |
State Unani Medical College Himmatganj Prayagraj Uttar Pradesh Pin Code 211016 |
| Address |
Departmant of Amraz e Ain Uzn Anf Halaq Wa Asnan State Unani Medical and HAHRDM Hospital Himmatganj Prayagraj
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
7060611241 |
| Fax |
|
| Email |
nusratmalik407@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Unani Medical College Himmatganj Prayagraj Uttar Pradesh Pin Code 211016 |
|
|
Primary Sponsor
|
| Name |
State Unani Medical College Himmatganj Prayagraj Uttar Pradesh |
| Address |
State Unani Medical College and HAHRDM Hospital Himmatganj Prayagraj Uttar Pradesh Pin Code 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 Malik Nusrat Fatima |
State Unani Medical College |
OPD no.6,Departmant of Amraz-e-Ain Uzn Anf Halaq Wa Asnan,Ground Floor,State Unani Medical and HAHRDM Hospital Himmatganj, Prayagraj
Allahabad
UTTAR PRADESH |
07060611241
nusratmalik407@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committtee(IEC) for Biomedical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J329||Chronic sinusitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Polyherbal Unani Formulation(Decoction) |
Patients will be given this compound test drug 33ml orally once daily for 6 weeks. |
| Comparator Agent |
Sharbat e Banafsha |
Patients will be given Sharbat e Banafsha in the dose of 20ml twice a day. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of either gender.
2.Patients in age group of 20-50 years.
3.Duration of the disease more than 12 week.
4.Patient having atleast two out of four cardinal symptoms(i.e., facial pain/pressure,hyposmia/anosmia,nasal obstruction,and nasal discharge for atleast 12 consecutive weeks.
5.Positive X-ray PNS finding(Thickened mucosal lining;opacity of sinus)
6.Those who give written informed consent. |
|
| ExclusionCriteria |
| Details |
1.Patient aged less than 20 years or more than 50 years.
2.Patients suffering from any congenital or acquired structural abnormalities like nasal dermoid cysts, deviated nasal septum, atrophic rhinitis, hypertrophic turbinates, adenoidal hypertrophy, and foreign bodies.
3.Pregnant or lactating women.
4.Patients suffering from systemic illness like hypertension, diabetes mellitus, malignancy, liver, and kidney dysfunction.
5.Patient not willing to attend regular treatment and follow-up for the entire duration of study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual Analog Scale(VAS)
SNOT-22 questionnaire for QOL |
2nd,4th and 6th week from baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
X RAY (PNS) - Water’s View
Absolute Eosinophil Count (AEC) |
2nd,4th,and 6th week from baseline. |
|
|
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)
|
23/08/2025 |
| 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 “A Randomized Comparative Clinical Study of Polyherbal Unani Formulation and Sharbat-e-Banafsha in the Management of Waram Tajawif al-Anf Muzmin (Chronic Rhinosinusitis)” aims to evaluate and compare the therapeutic efficacy of two Unani treatments—Joshanda (a polyherbal decoction) and Sharbat-e-Banafsha—in managing chronic rhinosinusitis, a persistent inflammation of the nasal and sinus mucosa. Chronic rhinosinusitis significantly affects quality of life and is often difficult to manage using conventional therapies, which involve prolonged use of antibiotics and steroids with potential side effects. This randomized, open-label clinical study will be conducted on 60 patients between 20–50 years of age, divided into two equal groups. The research involves both subjective (nasal obstruction, discharge, headache, etc.) and objective parameters (X-ray PNS, AEC), assessed through tools like the Visual Analogue Scale and SNOT-22 questionnaire. The study explores the Unani perspective of the disease, its classification, etiology, and traditional treatments, aiming to establish safer, cost-effective, and evidence-based alternatives for managing this chronic condition. |