| CTRI Number |
CTRI/2018/10/016178 [Registered on: 29/10/2018] Trial Registered Retrospectively |
| 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
|
Effect of Unani medicine Itrifal Ustukhudus in Nazla e Muzmin (Chronic Rhinosinusitis) |
|
Scientific Title of Study
|
Clinical Validation of Unani pharmacopoeial formulation Itrifal Ustukhudus in Nazla e 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 |
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 |
|
| 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 |
|
| Fax |
|
| Email |
ccrum507@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Kumar |
| Designation |
Research Officer (Pathology) |
| 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@gmail.com |
|
|
Source of Monetary or Material Support
|
| InfrastructuralSupport:1. Central Research Institute of Unani Medicine, Hyderabad 2. Central Research Institute of Unani Medicine, Lucknow 3.Regional Research Institute of Unani Medicine, Srinagar Monetary Support : Central Council for Research in Unani Medicine, New Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine |
| 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 Arshad II |
Central Research Institute of Unani Medicine |
Basaha, Kursi Road
Lucknow
UTTAR PRADESH |
09415793159
drmarshad93@gmail.com |
| Dr S Gulnawaz Ahmad |
Central Research Institute of Unani Medicine |
AG COLONY MARG, ERAGADDA
Hyderabad
ANDHRA PRADESH |
09848716693
skgulnawaz@gmail.com |
| Dr Huma |
Regional Research Institute of Unani Medicine |
Naseem Bagh Campus, University of Kashmir
Srinagar
JAMMU & KASHMIR |
9596550059
humma_rafiq@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Regional Research Institute of Unani Medicine, Srinagar |
Approved |
| Central Research Institute of Unani Medicine, Hyderabad |
Submittted/Under Review |
| Central Research Institute of Unani Medicine, Lucknow |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J329||Chronic sinusitis, unspecified, Nazla e Muzmin (Chronic Rhinosinusitis), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Itrifal Ustukhudus |
7 grams twice daily orally with lukewarm water daily |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of any in the age group of 19 to 60 years
2. Duration of disease >12 weeks
3. SNOT > 7
|
|
| 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
• Diabetes mellitus and any other illness requiring long term treatment
• Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction of SNOT-22 scores
Improvement in signs and symptoms of Zimad e Bars of Nazla e Muzmin (Chronic Rhinosinusitis) |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Resolution of findings of X –ray PNS |
at baseline and on completion of the protocol therapy ie after 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
25/04/2016 |
| 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) |
Open to Recruitment |
|
Publication Details
|
nil |
|
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 withNazla e Muzmin (Chronic Rhinosinusitis) After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinicallyevery fifteen days. 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, first follow up and on completion of
the protocol therapy. Composition
of Itrifal ustukhudus15
|
S. No.
|
Ingredients
|
Botanical / Zoological Name
|
Quantity
|
|
1.
|
Post-e-Halela
zard
|
Terminalia chebula
|
100gm
|
|
2.
|
Post
–e-Halela Kabuli
|
Terminalia chebula
|
100gm
|
|
3.
|
Halela Siyah
|
Terminalia chebula
|
100 gm
|
|
4.
|
Post-e-Balela
|
Terminalia bellerica
|
100 gm
|
|
5.
|
Aamla
|
Embilica officinalis
|
100 gm
|
|
6.
|
Gul-e-surkh
|
Rosa damescera
|
100 gm
|
|
7.
|
Ustukhudus
|
Lavendula stoechas
|
100 gm
|
|
8.
|
Bisfayej
|
Polypodium vulgare
|
100 gm
|
|
9.
|
Aftimoon
|
Cuscuta reflexa
|
100 gm
|
|
10.
|
Kishmish
|
Vitis vinifera
|
100 gm
|
|
11.
|
Roghan-e-zard
|
Clarified butter
|
20 gm
|
|
12.
|
Qand safaid
|
Sugar
|
3kg
|
|