| CTRI Number |
CTRI/2024/04/066283 [Registered on: 25/04/2024] Trial Registered Prospectively |
| Last Modified On: |
24/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Other |
|
Public Title of Study
|
A clinical study of Chronic Sinusitis and comparative evaluation of Unani formulations in its management |
|
Scientific Title of Study
|
A Clinical study of Warm-e-Tajaweef Anf Muzmin (Chronic sinusitis) and the comparative evaluation of Unani formulations in its management. |
| Trial Acronym |
CS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shama Rahmat |
| Designation |
PG Scholar |
| Affiliation |
Govt. Tibbi College and Hospital, Kadamkuan , Patna |
| Address |
Dept. of Moalajat, Govt. Tibbi Collge and Hospital, Kadamkuan, Patna, Pin code 800003
Patna
BIHAR
800003
India |
| Phone |
8859617414 |
| Fax |
|
| Email |
shamarahmat94.amu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shama Rahmat |
| Designation |
PG Scholar |
| Affiliation |
Govt. Tibbi College and Hospital, Kadamkuan , Patna |
| Address |
Dept. of Moalajat, Govt. Tibbi Collge and Hospital, Kadamkuan, Patna, Pin code 800003
Patna
BIHAR
800003
India |
| Phone |
8859617414 |
| Fax |
|
| Email |
shamarahmat94.amu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shama Rahmat |
| Designation |
PG Scholar |
| Affiliation |
Govt. Tibbi College and Hospital, Kadamkuan , Patna |
| Address |
Dept. of Moalajat, Govt. Tibbi Collge and Hospital, Kadamkuan, Patna, Pin code 800003
Patna
BIHAR
800003
India |
| Phone |
8859617414 |
| Fax |
|
| Email |
shamarahmat94.amu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Tibbi Collge and Hospital, Patna, Pin code- 800003, India |
|
|
Primary Sponsor
|
| Name |
Govt. Tibbi College and Hospital, Patna |
| Address |
Govt. Tibbi College and Hospital,Kadamkuan, Patna, Bihar, Pin code 800003 |
| Type of Sponsor |
Other [Government Tibbi College 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 |
| Shama Rahmat |
Government Tibbi College and Hospital, Patna |
Department of Moalajat , Government Tibbi College and Hospital, Kadamkuan, Patna, Pin Code 800003
Patna
BIHAR |
8859617414
shamarahmat94.amu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Tibbi College and Hospital, Kadamkuan, Patna, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J32||Chronic sinusitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Itrifal Kishneezi |
5 gram twice a day for 6 weeks |
| Intervention |
Itrifal Ustokhuddoos (Unani Medicine) |
5 gram twice a day for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex in age group 15 to 65 years.
Clinically diagnosed patients of chronic sinusitis.
Patients with involvement of any sinus.
Those who give written consent. |
|
| ExclusionCriteria |
| Details |
Patients of below 15 and above 65 years of age.
Patients who fail to give consent.
Patients who fail to follow up.
Pregnant & lactating mothers.
Patients with Malignancy of the nose or paranasal sinuses.
Patients having history of any surgery of nose or paranasal sinuses.
Patients having history of any foreign body in their nose.
Patient having history of trauma to nose or sinus areas.
Patients suffering from any congenital or acquired structural abnormality of the nasal cavity.
Patients of pulmonary Koch’s or patient having history of epistaxis.
Any medical condition where researcher feels that participation in the study could be detrimental to patient’s wellbeing. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Subjective and Objective Parameters |
Subjective and Objective Parameters |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety of the medicine |
Safety of the medicine |
|
|
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 |
|
Date of First Enrollment (India)
|
05/05/2024 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - 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 [shamarahmat94.amu@gmail.com].
- For how long will this data be available start date provided 28-03-2024 and end date provided 15-05-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is a open label Randomized comparative clinical trial to evaluate the efficacy of Unani formulation Itrifal Ustokhuddoos and Itrifal Kishneezi 5gm daily twice a day for 6 weeks. in the patients of chronic sinusitis and comparitive evaluation of both the formulation in the said disease. The purpose of the study is to provide safe and effective management of chronic sinusitis. |