| CTRI Number |
CTRI/2023/04/051601 [Registered on: 13/04/2023] Trial Registered Prospectively |
| Last Modified On: |
11/07/2023 |
| 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
|
clinical comparative study of unani drug in chronic rhinosinusitis |
|
Scientific Title of Study
|
A Clinical Study of Waram-e-Tajaweef-e-Anf Muzmin†(Chronic Rhinosinusitis) and the Comparative Evaluation of Sharbat-e-Banafsha and Joshandha Gaozaban in its Management |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohammad Tariq |
| Designation |
PG Scholar |
| Affiliation |
state Unani Medical College |
| Address |
Department of Amraze Ain Uzn Anf Halaq wa Asnan, State Unani
Medical College, himmatganj Prayagraj 211016 India, Allahabad
UTTAR PRADESH
211016 India
Allahabad UTTAR PRADESH 211016 India |
| Phone |
9927188397 |
| Fax |
|
| Email |
mohammadtariq49580@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Mohd Asif Hussain Usmani |
| Designation |
Professor HoD |
| Affiliation |
state Unani Medical College |
| Address |
Department of Amraze Ain Uzn Anf Halaq wa Asnan, State Unani
Medical College, himmatganj Prayagraj 211016 India, Allahabad
UTTAR PRADESH
211016 India
Allahabad UTTAR PRADESH 211016 India |
| Phone |
7905831926 |
| Fax |
|
| Email |
asifhussainusmani@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Usamah Ahmad |
| Designation |
associate professor |
| Affiliation |
state Unani Medical College |
| Address |
Department of Amraze Ain Uzn Anf Halaq wa Asnan, State Unani
Medical College, himmatganj Prayagraj 211016 India, Allahabad
UTTAR PRADESH
211016 India
Allahabad UTTAR PRADESH 211016 India |
| Phone |
9415639877 |
| Fax |
|
| Email |
arogyaherbal@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Unani Medical College, Prayagraj, Ministry of Ayush, govt. of Uttar pradesh |
|
|
Primary Sponsor
|
| Name |
State Unani Medical College Prayagraj |
| Address |
Department of Amraze Ain Uzn Anf Halaq wa Asnan, State Unani
Medical College, himmatganj Prayagraj 211016 India, Allahabad
UTTAR PRADESH
211016 India |
| 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 |
| Mohammad Tariq |
State Unani Medical College and HAHRDM Hospital |
OPD/IPD Department of Amraze Ain Uzn Anf Halaq wa Asnan, State Unani Medical College, himmatganj Prayagraj 211016 Allahabad UTTAR PRADESH |
9927188397
mohammadtariq49580@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics comittee |
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 |
| Comparator Agent |
Joshandha Gaozaban(oral) |
Joshandha Gaozaban will be given 45ml twice a day for the 6 weeks. |
| Intervention |
Sharbat-e-Banafsha (oral) |
Sharbat-e-Banafsha will be given in the dose of 25 ml twice a day orally for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients fulfilling AAO-HNS criteria that is at least two major criteria
(Nasal obstruction or blockage, anterior or posterior nasal discharge, Facial pain /congestion, Purulence in a nasal cavity on examination, Anosmia/ Hyposmia) or one major and two minor criteria (Halitosis, earache, dental pain, cough, fatigue)
2 patients had an opacity of X-ray paranasal sinuses (waters view) ranging from +1 (Mucosal thickening) to +3 (complete opaque antrum) grading.
3 Patients of either sex.
4 Patients in the age group of 18 to 60 years.
5 Patients with involvement of any sinus.
6 Those who give written consent.
|
|
| ExclusionCriteria |
| Details |
1 Child below 18 years of age.
2 Patients above 60 years of age.
3 Pregnant & lactating mothers.
4 Patients who fail to give consent.
5 Patients who fail to follow up.
6 Mentally retarded persons.
7 Patients with Malignancy of the nose or paranasal sinuses.
8 Patients have a history of any surgery of the nose or paranasal sinuses.
9 Patients have a history of any foreign body in their nose.
3Patient have a history of trauma to the nose or sinus areas.
10 Patients suffering from any congenital or acquired structural abnormality of the nasal cavity.
11 Any medical condition where the physician feels that participation in the study could be detrimental to patientsÂ’ wellbeing.
12 Patients of pulmonary Kochs or patients having history of epistaxis
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 reduction in AAO-HNS criteria
2 reduction in X-ray paranasal sinuses (waters view) ranging from +1 (Mucosal thickening) to +3 (complete opaque antrum) grading. |
0 and 6 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement in clinical features |
0 and 6 week |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
15/04/2023 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The term sinusitis is replaced by rhinosinusitis because sinusitis is often preceded by rhinitis and rarely occurs without concurrent nasal airway inflammation. Thus, the refers to inflammation of the mucosal lining of nose and paranasal sinuses. Chronic rhinosinusitis is very common condition and has been estimated to affect approximately 5-15% of general population. It is often very frustrating and difficult to treat therefore many patients have undergone with repeated courses of antibiotics, long term use of oral or topical steroids and multiple sinus surgeries increasing their risk of colonization with antibiotic resistant agent, various side effects of steroids and of surgical complications. Approximately 200000 U.S adult undergo sinus surgery per year for chronic rhinosinusitis, most commonly because of failing medical therapy. As far as economic impact is concerned, CRS accounts for substantial healthcare expenditure in terms of doctor’s visits, antibiotic prescribed, lost work days and missed school days. In unani literature there is no specific description of Waram-e-Tajaweef-e-Anf Muzmin (chronic rhinosinusitis) but the features described by unani physicians under nazla barid and nazla muzmin in various books corresponds with signs and symptoms of sinusitis. Unani system of medicine provides abundance of single and compound drugs which can be given in nazla barid for longer duration without any known side effect. The goal of the research work is to provide economical, effective and consecutive management of chronic rhinosinusitis and to protect the patient from known side effects of modern medicine. Moreover, to achieve and maintain clinical control, avoid complications and to minimize the surgical requirement by using two different Unani formulations Sharbat-e-Banafsha and Joshandha Gaozaban (Gaozaban Gul-e-gaozaban, Asl-us-soos Qand safed), two separate groups and also to compare their effects on relieving the symptoms of chronic rhinosinusitis |