| CTRI Number |
CTRI/2018/02/012244 [Registered on: 28/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
21/12/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Trial to study the Effect of Unani formulation in Chronic Rhinosinusitis |
|
Scientific Title of Study
|
The Efficacy of Unani formulation in Waram tajaweef anaf muzmin (Chronic Rhinosinusitis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohammad Irfan Ansari |
| Designation |
PG Scholar( Unani Medicine) |
| Affiliation |
Rajiv Gandhi University of Health Sciences, Karnataka |
| Address |
National Institute of Unani Medicine, MAGADI MAIN ROAD
KOTTEGEPLAYA, Bangalore
Boys hostel Room no. 09, National Institute of Unani Medicine, MAGADI MAIN ROAD
KOTTEGEPLAYA, Bangalore
Bangalore
KARNATAKA
560091
India |
| Phone |
8687071653 |
| Fax |
|
| Email |
mohdirfanansari786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MDA Bhat |
| Designation |
Lecturer (Unani Medicine) |
| Affiliation |
National Institute of Unani Medicine |
| Address |
National Institute of Unani Medicine, Kottigepallya, Magdi main road,Bengaluru
National Institute of Unani Medicine, Kottigepallya, Magdi main road,Bengaluru, 560091
Bangalore
KARNATAKA
560091
India |
| Phone |
9590366192 |
| Fax |
|
| Email |
drmuzaffar79@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohammad Irfan Ansari |
| Designation |
PG Scholar ( Unani Medicine) |
| Affiliation |
Rajiv Gandhi University of Health Sciences, Karnataka |
| Address |
Boys hostel Room no. 09, National Institute of Unani Medicine, MAGADI MAIN ROAD
KOTTEGEPLAYA, Bangalore
Boys hostel Room no. 09, National Institute of Unani Medicine, MAGADI MAIN ROAD
KOTTEGEPLAYA, Bangalore
Bangalore
KARNATAKA
560091
India |
| Phone |
8687071653 |
| Fax |
|
| Email |
mohdirfanansari786@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Unani Medicine NIUM Bengaluru |
|
|
Primary Sponsor
|
| Name |
National Institute of Unani Medicine NIUM Bengaluru |
| Address |
KOTTEGEPLAY MAGDI MAIN ROAD |
| 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 Irfan Ansari |
National Institute of Unani Medicine (NIUM), Bangalore |
Boys Hostel Room no. 09, National Institute of Unani Medicine (NIUM), Department of Moalijat/Medicine, Kottigepalya, Magadi Main Road 569001
Bangalore
KARNATAKA |
8687071653
mohdirfanansari786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC NIUM, Bangalore, Karnataka |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Chronic Rhinosinusitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nill |
Nill |
| Intervention |
Unani formulation |
Ingredients:
1. Gule banafsha (Viola odorata) 7g
2. Ustukhuddoos (Lavandula stoechas) 7g
3. Aslussoos (Glycyrrshiza glabra) 7g
4. Misri 25g
All the ingredients of unani formulation will be soaked in 400 ml of water for whole night, next morning soaked drugs with water will be allowed to boil till water reduces to half (200 ml). The decoction (joshanda) is filtered and misri 25g will be dissolved in it. Patient will be advised to take 100 ml of lukewarm decoction (joshanda) orally daily before meal twice a day for 30days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
•Both gender
•≥8 weeks of persistent symptoms
•Meet ≥2 of 5 major symptoms criteria:
 Facial pain and pressure
 Facial Congestion
 Nasal obstruction
 Nasal discharge
 Olfactory disturbance (Smell)
•X-ray of PNS (Water’s view) shows haziness/ opacity and may show free fluid level.
|
|
| ExclusionCriteria |
| Details |
• Pregnancy and Lactation.
• Patients with known systemic and metabolic diseases.
• Patients with the history of trauma and accidents.
• Diagnosed cases of external injuries, nasal polyp, nasal growth and adenoids
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome: Relief of Major Symptoms |
Primary outcome: This was assessed by using VAS and SNOT-22 scores. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcome: changes in X-ray findings. |
Secondary outcome: Assessed by X-ray findings. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="29" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
11/04/2016 |
| Date of Study Completion (India) |
01/03/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study was before and after comparison interventional study. This trial assessed the efficacy of a Unani formulation in 30 patients with Chronic rhinosinusitis by X-ray PNS. All the ingredients of unani formulation such as- Ustokhuddoos (7gm), Gule Banafsha (7gm), Aslussoos (7gm) will be soaked in 400 ml of water for whole night, next morning soaked drugs with water will be allowed to boil till water reduces to half (200 ml). The decoction (joshanda) is filtered and misri 25g will be dissolved in it. Patient will be advised to take 100 ml of lukewarm decoction (joshanda) orally daily before meal for 30 days. The study was conducted at National Institute of Unani Medicine, Bangalore. Primary outcome measure was VAS for improving the overall severity of symptoms and SNOT-22 for quality of life in patients before and after treatment. Secondary outcome measure was effective change in X-ray of PNS findings. |