| CTRI Number |
CTRI/2018/08/015444 [Registered on: 23/08/2018] Trial Registered Prospectively |
| Last Modified On: |
04/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of Chronic Rhinosinusitis with Unani Medicine Itrifal Zamani. |
|
Scientific Title of Study
|
Clinical Validation of Unani Pharmacopoeal formulation Itrifal Zamani in Nazla Muzmin (Chronic Rhinosinusitis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NM/CRS/IZ/CLNVAL/CCRUM 16-17 version 1 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Naheed Parveen |
| Designation |
Assistant Director (Unani) |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
|
| Fax |
|
| Email |
ccrum507@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naheed Parveen |
| Designation |
Assistant Director (Unani) |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
|
| Fax |
|
| Email |
ccrum507@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Kumar |
| Designation |
Research Officer (Path) SIV |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
|
| Fax |
|
| Email |
drpradeepkumar2001@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Source of Monetary or Material Support Infrastructural support : 1 Regional Research Institute of Unani Medicine (CRIUM), Kolkata 2. Regional Research Institute of Unani Medicine(RRIUM), New Delhi 3 Regional Research Institute of Unani Medicine(RRIUM), Aligarh 4 Clinical Research Unit (CRU) Meerut Monetary Support : Central Council for Research in Unani Medicine (CCRUM), New Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine CCRUM New Delhi |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mohd Tariq Khan |
Clinical Research Unit |
Research OPD Room Nazla Muzmin (Chronic Rhinosinusitis)
Cantonment General Hospital Begum Bridge (Soti Ganj)
Meerut
UTTAR PRADESH |
8266001184
doctormtk@gmail.com |
| Dr Anwarul Islam |
Regional Research Institute of Unani Medicine |
Research OPD Room Nazla Muzmin (Chronic Rhinosinusitis)
D-11, Abul Fazal Enclave, Jamia Nagar,
South
DELHI |
9911926730
dranwarulislam@gmail.com |
| Dr Humaira Bano |
Regional Research Institute of Unani Medicine |
Research OPD Room Nazla Muzmin (Chronic Rhinosinusitis)
Post Box 70, Near Head Post Office
Aligarh
UTTAR PRADESH |
8439430091
banu786.mau@gmail.com |
| Dr Younis I Munshi |
Regional Research Institute of Unani Medicine |
Research OPD Room Nazla Muzmin (Chronic Rhinosinusitis)
G T Road (North) Near Jaiswal Hospital
Kolkata
WEST BENGAL |
9419086700
younismunshi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Clinical Research Unit Meerut |
Approved |
| Regional Research Institute of Unani Medicine Aligarh |
Approved |
| Regional Research Institute of Unani Medicine Kolkata |
Approved |
| Regional Research Institute of Unani Medicine New Delhi |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Nazla Muzmin (Chronic Rhinosinusitis), (1) ICD-10 Condition: J329||Chronic sinusitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Itrifal Zamani |
Itrifal Zamani Semi solid Oral 7gm at bedtime to be taken with warm water for six weeks |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of any in the age group of 18 to 60 years
2. Radiologically diagnosed Rhinosinusitis of more than12 weeks duration
3. SNOT Score > 11
|
|
| ExclusionCriteria |
| Details |
1. Rhinosinusitis /Sinusitis of < 12 weeks
2. Deviated Nasal septum
3. Nasal polyps
4. Local pathology such as mucocele, cyst, antrochoanal polyp, facial trauma, radiation injury, or birth defect
5. Diabetes mellitus and any other illness requiring long term treatment
6. Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| improvement in the sign and symptoms of Nazla Muzmin (Chronic Rhinosinusitis) |
six weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hematological and biochemical assessments for safety |
six weeks |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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)
|
24/08/2018 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a multicentric open trial in patients with Nazla Muzmin (Chronic Rhinosinusitis) After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at every two weeks. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be six weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.Composition of Itrifal Zamani 16
|
S. No.
|
Ingredients
|
Quantity
|
|
1
|
Post HalelaZard
|
50 g
|
|
2
|
Post Halelakabuli
|
50 g
|
|
3
|
HalelaSiyah
|
50 g
|
|
4
|
Gul e Banafsha
|
50 g
|
|
5
|
Saqmunia
|
50 g
|
|
6
|
Turbud
|
100 g
|
|
7
|
Kishneez
|
100 g
|
|
8
|
Post Balela
|
25 g
|
|
9
|
Amla
|
25 g
|
|
10
|
Gul e Surkh
|
25 g
|
|
11
|
Tabasheer
|
25 g
|
|
12
|
Gul e Nilofer
|
25 g
|
|
13
|
Sandal Safaid
|
15 g
|
|
14
|
Kateera
|
15 g
|
|
15
|
RoghanBadaam
|
120 g
|
|
16
|
Unnab
|
150 g
|
|
17
|
Sapistan
|
100 g
|
|
18
|
SheeraMurabbaHaleela
|
1 Kg
|
|
19
|
Asl or QandSafaid
|
1 Kg
|
|
20
|
Gul e Banafsha
|
50 g
|
|