| CTRI Number |
CTRI/2025/05/086758 [Registered on: 13/05/2025] Trial Registered Prospectively |
| Last Modified On: |
13/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study on Chronic Sinusitis and the Effectiveness of Unani formulation in its Treatment |
|
Scientific Title of Study
|
A Clinical Study on Warm e tajaweef e anf muzmin (Chronic rhinosinusitis) and the comparative evaluation of Unani formulations in its management. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anam Fatema |
| Designation |
MD Scholar (Unani) |
| Affiliation |
Ajmal Khan Tibbiya College |
| Address |
Department of Moalejat, Ajmal Khan Tibbiya College,AMU,Near Tasveer Mahal
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9870720719 |
| Fax |
|
| Email |
anamfatema2485@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mursaleen Naseer |
| Designation |
Assistant Professor |
| Affiliation |
Ajmal Khan Tibbiya College |
| Address |
Department of Moalejat, Ajmal Khan Tibbiya College,AMU,Near Tasveer Mahal
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9412562724 |
| Fax |
|
| Email |
drmursaleen@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mursaleen Naseer |
| Designation |
Assistant Professor |
| Affiliation |
Ajmal Khan Tibbiya College |
| Address |
Department of Moalejat, Ajmal Khan Tibbiya College,AMU,Near Tasveer Mahal
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9412562724 |
| Fax |
|
| Email |
drmursaleen@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Moalejat,AjmaL Khan Tibbiya College Hospital, Aligarh Muslim University, Aligarh,Aligarh,202002 |
|
|
Primary Sponsor
|
| Name |
Department of Moalejat Ajmal Khan Tibbiya CollegeAligarh Muslim University Aligarh |
| Address |
Department of Moalejat, Ajmal Khan Tibbiya College, Aligarh Muslim University, Aligarh 202002 |
| 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 |
| Anam Fatema |
Ajmal Khan Tibbiya College Hospital , Aligarh Muslim University, Aligarh |
Ajmal Khan Tibbiya College Hospital ,Aligarh Muslim University
Aligarh
UTTAR PRADESH |
9870720719
anamfatema2485@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTIUTIONAL ETHICAL COMMITTEE |
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 |
Mufeed Joshanda |
Each sachet contains
Sapistan (Cordia latifolia) : 9 in no.
Aslusoos (Glycirrhiza glabra ): 4 gm
Barg-e-gaozaban (boraggo officinalis ): 4 gm
Unnab wilayati (ziziphus sativa) 5 gm
Gul-e-banafsha (viola odorata ): 4 gm
1 Sachet twice a day in the form of decoction |
| Comparator Agent |
Sinugard Granules |
Ustukhuddoos (Lavendula stoechos ) 500mg
Aslussoos (Glycirrhiza glabra ) 550mg
Badiyan (Foeniculum vulgare ) 550mg
Menthol 60mg
Cane Suger 250mg
1 sachet , twice a day in the form of decoction |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed patients of chronic Rhinosinusitis of not more than 5 years duration.
Patients of both sexes.
Patients in the age group of 15 to 50 years.
Patients with involvement of any sinus.
Those who give written consent.
Patients complaining of post nasal drip
-Subjective Parameters
Nasal obstruction
Nasal discharge
Sneezing
Headache
Post nasal drip
Abnormalities of smell
Heaviness in head
-Objective Parameters
Xray PNS (water’s view)
|
|
| ExclusionCriteria |
| Details |
Patients having history of any surgery of nose or paranasal sinuses
Patients with Malignancy of the nose or paranasal sinuses.
Patients having history of any foreign body in their nose.
Pregnant & lactating mothers.
Patients who fail to give consent.
Patients who fail to follow up..
patient having history of epistaxis.
Patient having history of trauma to nose or sinus areas Pregnant & lactating mothers.
Patients suffering from any congenital or acquired structural abnormality of the nasal cavity.
Any medical condition where physician feels that participation in the study could be detrimental to patient’s well being.
Patients of pulmonary koch’s |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in objective parameters.
Nasal obstruction
Nasal discharge
Sneezing
Headache
Post nasal drip
Abnormalities of smell
Heaviness in head
|
60 days with baseline and after the completion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assesment of the opacity in the Xray (PNS)
Assesment of the mucosal thickening |
60 days with the baseline and after the completion |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
N/A |
|
Date of First Enrollment (India)
|
25/05/2025 |
| 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
|
- Chronic Rhinosinusitis (CRS) affects 5–15% of the population and is often difficult to treat, leading to repeated antibiotic use, long-term steroid therapy, and multiple sinus surgeries. These treatments carry risks such as antibiotic resistance, steroid side effects, and surgical complications. Approximately 200,000 U.S. adults undergo sinus surgery annually due to failed medical therapy. CRS also results in significant economic burden and negatively impacts quality of life, often more than other chronic diseases.
- While Unani medicine does not directly name Chronic Rhinosinusitis, its symptoms align with conditions like Nazla Barid and Nazla Muzmin. Unani treatments, especially using single or compound herbal formulations, are considered safer for long-term use. This research aims to evaluate the efficacy of Mufeed Joshanda in management of Chronic rhinosinusitis and to evaluate the efficacy of Sinugard Granules in management of chronic rhinosinusitis, to compare the efficacy of both unani formulations in management of chronic rhinosinusitis
|