| CTRI Number |
CTRI/2021/09/036532 [Registered on: 15/09/2021] Trial Registered Prospectively |
| Last Modified On: |
09/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani
Other (Specify) [Therapeutic] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study on Waram-e-tajaweef anf muzmin (chronic rhinosinusitis) and comparative evaluation of qurs e musakkin and mufeed joshanada in its management |
|
Scientific Title of Study
|
A Clinical Study on Warm-e Tajaweef-e-Anf-Muzmin (Chronic Rhinosinusitis) and Comparative Evaluation of Unani Formulations in its Management:A Randomized,single blind parallel Group comparative study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Foziya KHANAM |
| Designation |
Pg scholar deptt of moalejat AKTCH AMU |
| Affiliation |
Department of moalejat Ajmal khan tibbiya college and hospital AMU |
| Address |
Department of ajmal khan tibbiya college and hospital aligarh muslim university aligarh 202002
Department of ajmal khan tibbiya college and hospital aligarh muslim university aligarh 202002
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9045273259 |
| Fax |
|
| Email |
foziyakhandec@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Misbahuddin siddiqi |
| Designation |
Professor department of moalejat |
| Affiliation |
Department of moalejat Ajmal khan tibbiya college and hospital AMU |
| Address |
Department of moalejat ajmal khan tibbiya college and hospital aligarh muslim university aligarh 202002
Department of moalejat ajmal khan tibbiya college and hospital aligarh muslim university aligarh 202002
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9837030145 |
| Fax |
|
| Email |
misbahuddin.dr1980@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Foziya KHANAM |
| Designation |
Pg scholar deptt of moalejat AKTCH AMU |
| Affiliation |
Department of moalejat Ajmal khan tibbiya college and hospital AMU |
| Address |
Department of ajmal khan tibbiya college and hospital aligarh muslim university aligarh 202002
Department of ajmal khan tibbiya college and hospital aligarh muslim university aligarh 202002
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9045273259 |
| Fax |
|
| Email |
foziyakhandec@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aligarh muslim university |
|
|
Primary Sponsor
|
| Name |
Department of moalejat Ajmal khan tibbiya college and hospital Aligarh muslim university |
| Address |
Department of moalejat , Ajmal khan tibbiya college and hospital Aligarh muslim university ,Aligarh uttar pradesh 202002 |
| Type of Sponsor |
Other [Department of moalejat , Ajmal khan tibbiya college and hospital Aligarh muslim university] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Foziya khanam |
Ajmal khan tibbiya college and hospital aligarh muslim university |
Department of moalejat , Ajmal khan tibbiya college and hospital Aligarh muslim university
Aligarh
UTTAR PRADESH |
9045273259
foziyakhandec@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J329||Chronic sinusitis, unspecified. Ayurveda Condition: Chronic rhinosinusitis, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | For Group A : Qurs e musakkin For Group B : Mufeed joshanda | For Group A:
Qurs-e-musakkin(500 mg )
Ingredients.
Ustukhuddus (lavandula stoechos) : 114.25 mg
kishneez khushk (coriandrum sativum) : 114.25 mg
filfil siyah (piper nigrum) : 14.28 mg
Asrol (Rauvolfia serpentine): 42.5 mg
Naushadar (Ammonium chloride) : 14.28 mg
Barg e sudab (Ruta graveolens): 142.85 mg
Samagh –e- arabi (Acacia Arabica) : 57.14 mg
Nishasta makkai (zea mays) : Q.S.
For Group B : Mufeed joshanda
Ingredients :
Sapistan (Cor |
|
|
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Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients fulfilling AAO-HNS criteria that is atleast two major criteria
(Nasal obstruction or blockage ,anterior or posterior nasal discharge ,Facial pain /congestion , Purulence in nasal cavity on examination ,Anosmia/ Hyposmia ) or one major and two minor criteria (Halitosis , earache, dental pain , cough , fatigue)
patients having opacity of Xray paranasal sinuses ( water’s view )ranging from +1 (Mucosal thickening )to +3 (complete opaque antrum) grading.
Patients of either sexes.
Patients in the age group of 15 to 50 years.
Patients with involvement of any sinus.
Those who give written consent.
|
|
| ExclusionCriteria |
| Details |
1.Children below 15 years of age.
2.Patients above 50 years of age.
3. Pregnant & lactating mothers.
4.Patients who fail to give consent.
5.Patients who fail to follow up.
6.Mentally retarded persons.
7.Patients with Malignancy of the nose or paranasal sinuses.
8.Patients having history of any surgery of nose or paranasal sinuses.
9.Patients having history of any foreign body in their nose.
10.Patient having history of trauma to nose or sinus areas.
11.Patients suffering from any congenital or acquired structural abnormality of the nasal cavity.
12.Any medical condition where physician feels that participation in the study could be detrimental to patient’s well being.
13.Patients of pulmonary koch’s or patient having history of epistaxis. |
|
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Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in clinical features |
Weekly for 6 weeks |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in the X-ray PNS waters view with the help of an arbitrary scale |
At start of the intervention and at the end of the 6 week |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/09/2021 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
A clinical study on waram-e-tajaweef anf muzmin (chronic rhinosinusitis and comparative evaluation of unani formulations (qurs e musakkin and mufeed joshanda) in its management |