| CTRI Number |
CTRI/2024/10/074920 [Registered on: 08/10/2024] Trial Registered Prospectively |
| Last Modified On: |
30/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The role of oral steroids with
itraconazole versus antibiotics in allergic fungal
rhinosinusitis |
|
Scientific Title of Study
|
Comparative study of the role of oral steroids with
itraconazole antibiotics in allergic fungal
rhinosinusitis |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tanisha Goel |
| Designation |
Post graduate student |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of ENT,
Government Medical College and Hospital, sector 32
Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9810071696 |
| Fax |
|
| Email |
tanisha287@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surinder Kumar Singhal |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of ENT,
Government Medical College and Hospital, sector 32
Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121547 |
| Fax |
|
| Email |
singhalsks@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tanisha Goel |
| Designation |
Post graduate student |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of ENT,
Government Medical College and Hospital, sector 32
Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9810071696 |
| Fax |
|
| Email |
tanisha287@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Hospital, Sector 32, Chandigarh, India, pin code 160030, |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital |
| Address |
Sector 32, Chandigarh, Pin code 160030 |
| 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 |
| Dr Tanisha Goel |
Government Medical College and Hospital, Chandigarh |
Room 3417,ENT OPD B Block 3rd floor, Governement Medical College and Hospitalsector 32, Chandigarh
pin code 160030
Chandigarh
CHANDIGARH |
9810071696
tanisha287@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee (GMCH, Chandigarh) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J308||Other allergic rhinitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oral antibiotics and oral steroids |
Oral antibiotics (amoxicillin and clavulanic acid 625 mg TDS for adults and children weighing more than 40 kg; if intolerance to Amoxycillin present then 3 rd generation cephalosporins will be administered) with steroids in tapering dose (1 mg/kg OD) in tapering doses for 15 days |
| Comparator Agent |
Oral Itraconazole and oral steroids |
Oral itraconazole (200 mg OD) and oral steroid (1mg/kg OD) in tapering doses for 15 days |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
99.99 Year(s) |
| Gender |
Both |
| Details |
Patients of allergic fungal rhinosinusitis diagnosed on the basis of NCCT scan Nose Paranasal
sinuses findings. |
|
| ExclusionCriteria |
| Details |
1.History of previous surgery
2. Contraindications of steroid use:
a. Diabetes mellitus
b. Peptic ulcer disease
c. Tuberculosis
d. Osteoporosis
e. Glaucoma
f. Congestive heart failure
g. Subcapsular cataract
3. Samter’s triad (bronchial asthma, nasal polyps, aspirin intolerance)
4. Hepatic disease
5. Drugs metabolised extensively by CYP3A4 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Compare efficacy of oral itraconazole and oral antibiotics versus oral steroids in Allergic Fungal
Rhinosinusitis using:
1. NCCT nose PNS (Lund and Mackey radiological scoring system)
2. serum Total IgE levels
|
15 days per participant |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Compare efficacy of oral itraconazole and oral antibiotics versus oral steroids in Allergic Fungal
Rhinosinusitis using:
1. nasal endoscopy (Kupferberg Endoscopic Scoring and Lund Kennedy scoring system)
2. Sinonasal Outcome Test -22 score and Visual analogue scale scores with respect to nasal endoscopic scoring |
15 days per participant |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/10/2024 |
| 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 Yet Recruiting |
| 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 single centre prospective Randomised Clinical Trial for 18 months with the intention to compare the efficacy of two drug regimens: Oral Steroids in tapering doses and oral antibiotics versus oral steroids in tapering doses with oral itraconazole in 100 cases of Allergic Fungal Rhinosinusitis diagnosed on the basis of NCCT scan Nose Paranasal sinuses findings is planned. The patients with contraindications for steroid use, history of previous surgery, Samter’s triad, hepatic disease, drugs metabolised extensively by CYP3A4 are excluded. The treatment outcomes will be assesed pre and post 15 day treatment by using tools like NCCT nose PNS (Lund and Mackey radiological scoring system), nasal endoscopy (Kupferberg Endoscopic Scoring and Lund Kennedy scoring system), serum Total IgE levels, Sinonasal Outcome Test -22 score and Visual analogue scale scores. |