| CTRI Number |
CTRI/2023/03/051156 [Registered on: 29/03/2023] Trial Registered Prospectively |
| Last Modified On: |
28/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani
Diagnostic |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Treatment of chronic sinusitis by nuskha joshanda nazla barid. |
|
Scientific Title of Study
|
Therapeutic evaluation of
the unani formulation in management of warm tajaweef-e- anaf muzmin -A randomised open study with placebo |
| Trial Acronym |
CS-NJNB |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shamaila khan |
| Designation |
M.D Scholar(UNANI) |
| Affiliation |
Ajmal khan tibbiya college |
| Address |
Department of moalejat,faculty of unani medicine,AKTC,AMU
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
9540008810 |
| Fax |
|
| Email |
shamaila.khan2015@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Tanzeel Ahmad |
| Designation |
Professor |
| Affiliation |
ajmal khan tibbiya college faculty of unani medicine moalejat |
| Address |
Department of moalejat Ajmal khan tibbiya college Aligarh Muslim university
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9448123337 |
| Fax |
|
| Email |
tanzeel1967@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shamaila khan |
| Designation |
PG Scholar department of moalejat |
| Affiliation |
ajmal khan tibbiya college faculty of unani medicine moalejat |
| Address |
Department of moalejat ajmal khan tibbiya college Aligarh Muslim university
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9540008810 |
| Fax |
|
| Email |
shamaila.khan2015@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of moalejat Ajmal khan tibbiya college Aligarh Muslim university Aligarh 202002 |
|
|
Primary Sponsor
|
| Name |
Department of moalejat Ajmal khan tibbiya college Aligarh Muslim university Aligarh |
| Address |
Department of moalejat Ajmal khan tibbiya college Aligarh Muslim university Aligarh 202002 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Shamaila khan |
Ajmal khan tibbiya college hospital |
Department of moalejat,faculty of unani medicine,aligarh muslim university,aligarh
Aligarh
UTTAR PRADESH |
9540008810
shamaila.khan2015@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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
decoction of joshanda nazla barid |
The contents of one polypacks containing 31 grams of crushed drugs will be soaked in 200 ml of water for an entire night. Next morning, soaked drugs along with same water will be allowed to boil till the water reduced to half. The obtained filter will be divided into two halves and each half will be advised to be taken orally in the morning and evening separately before meals for 45 days(1.5 month) |
| Comparator Agent |
placebo (wheat flour capsules) |
2 capsules (500mg)BD will be given before meals for 45 days(1.5month) |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed patients of chronic sinusitis through objective parameters[Assessment of opacity and Assessment of mucosal thickening by xray pns w/v] and subjective parameters[1. Nasal Obstruction
2. Nasal discharge
3. Sneezing
4. Headache
5.Post nasal drip
6.Abnormalites of smell
7.Heaviness in head
8. Tenderness of sinuses]
Patients of both sexes.
Patients in the age group of 20 to 60 years.
Those who give written consent.
|
|
| ExclusionCriteria |
| Details |
Patients below 20 years of age.
Patients above 60 years of age.
Pregnant & lactating mothers.
Patients who fail to give consent.
Patients who fail to follow up.
Mentally retarded persons.
• Patients of diabetes mellitus or any comorbid disease.
• Malignancy of nose and paranasal sinuses.
• Patients having any history of trauma to nose or sinus area, any surgery of nose or paranasal sinuses.
• Patients having any congenital and acquired structural abnormality of the nasal cavity.
• Any medical condition where physician feels that participation in the study could be detrimental to patient well being.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
improvement in Objective parameters
Assessment of
opacity
Assessment of
mucosal
thickening through arbitary grading |
45 days with basline and after completion. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
improvement in Subjective parameters
1. Nasal Obstruction
2. Nasal discharge
3. Sneezing
4. Headache
5.Post nasal drip
6.Abnormalites of smell
7.Heaviness in head
8. Tenderness of sinuses through arbitary grading. |
45 days on fortnighly follow ups. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
05/04/2023 |
| 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
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Chronic sinusitis is characterised by nasal discharge ,obstruction,sneezing,headche which often necetitates the patients to undergo modern interventions such as use of anti histaminics, analgesics for long term use and later on surgical intervention. Under such circumstances ,unani system boasts to have a treasure of safe and effective unani drugs with minimal side effects.In order to reduce the cost of management of chronic sinusitis in all aspects and reduce the side effects of modern medicines,this trial consisting of decoction of gul e banafsha,barg e gaozaban,tukhme khatmi,tukhme khubbazi,unnab has been designed to evaluate the efficacy of nuskha joshanda nazla barid in patients of chronic sinusitis. |