| CTRI Number |
CTRI/2019/03/017945 [Registered on: 06/03/2019] Trial Registered Prospectively |
| Last Modified On: |
01/03/2019 |
| 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 (Inflamation of Sinusis and Nasal cavity) with Unani medicine Itrifal Kishneezi |
|
Scientific Title of Study
|
Clinical Validation of Unani Pharmacopoeial Formulation Itrifal
Kishneezi in Nazla Muzmin (Chronic RhinoSinusitis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NM/CR/IK/CLNVAL/CCRUM/17-18, version 1 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Asim Ali Khan |
| Designation |
Director General |
| 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 |
01128525715 |
| Fax |
|
| Email |
unanimedicine@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naheed Parveen |
| Designation |
Assistant Director |
| 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 |
9213511298 |
| Fax |
|
| Email |
ccrum507@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Kumar |
| Designation |
Research Officer (Pathology) S-IV |
| 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 |
8800263300 |
| Fax |
|
| Email |
drpradeepkumar2001@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support : 1 Regional Research Institute of Unani Medicine (RRIUM), Kolkata 2. Regional Research Institute of Unani Medicine (RRIUM), Patna 3. 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 |
| 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 = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mohd Tariq Khan |
Clinical Research Unit |
Cantonment General Hospital, Begum Bridge (Soti Ganj)
Meerut
UTTAR PRADESH |
09012843253
doctormtk@gmail.com |
| Dr Mumtaz Ahmad |
Regional Research Institute of Unani Medicine |
Guzri, Patna City
Patna
BIHAR |
9140843920
ahmadmumtaz1966@gmail.com |
| Dr Younis I Munshi |
Regional Research Institute of Unani Medicine (RRIUM) |
250A/29,G T Road (North), Liluah
Haora
WEST BENGAL |
09419086700
younismunshi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Clinical Research Unit, Meerut |
Submittted/Under Review |
| Regional Research Institute of Unani Medicine, Kolkata |
Submittted/Under Review |
| Regional Research Institute of Unani Medicine, Patna |
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 |
Itrifal Kishneezi |
10 gm Orally twice daily to be taken with water for 4 weeks |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex of age 18-65 years
2. Patients with Sino-Nasal Outcome Test (SNOT) > 7
3. Patients clinically diagnosed of sinusitis of duration > 12 weeks with radiological changes. |
|
| ExclusionCriteria |
| Details |
1. Patients of sinusitis with epistaxis, hypertension shall be excluded from the study
2. Patient having any growth in the nose like nasal polyps etc.
3. Patients with co-morbidity requiring long term treatment.
4. Pregnant and lactating females. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in sign and symptoms of Nazla Muzmin (Chronic RhinoSinusitis) |
04 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological and biochemical assessment for safety assessment |
Investigations will be done at baseline and end of treatment |
|
|
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 3 |
|
Date of First Enrollment (India)
|
11/03/2019 |
| 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
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is designed as 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 week. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 4 weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.
|
S. No.
|
Ingredients
|
Botanical / Scientific Name
|
Quantity
|
|
1.
|
Post- Halela Zard
|
Terminalia
chebula Retz
|
100gm
|
|
2.
|
Post-Halela Kabli
|
Terminalia
chebula Retz
|
100gm
|
|
3.
|
Halela Siyah
|
Terminalia
chebula Retz
|
100gm
|
|
4.
|
Aamla
|
Emblica
officinalis Gaertn
|
100gm
|
|
5.
|
Post-e-Balela
|
Terminalia
bellirica Roxb.
|
100gm
|
|
6.
|
Kishneez Khushk
|
Coriandrum
sativum Linn.
|
100gm
|
|
7.
|
Asal / Qand Safaid
|
Honey
/ Sugar
|
1.8 kg
|
|
8.
|
Raughan-e-Badam / Raughan-e-Zard
|
Almond
oil / Purified Ghee
|
Q.S
|
|