| CTRI Number |
CTRI/2022/02/040083 [Registered on: 07/02/2022] Trial Registered Prospectively |
| Last Modified On: |
05/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Nasal Douching] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Allergy of Nose |
|
Scientific Title of Study
|
Prospective study to evaluate the Efficacy of Nasal douches in treatment of vitamin D deficient Allergic Rhinitis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Diwash Sunar |
| Designation |
Junior Resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
AIIMS, Department of ENT head and neck surgery, Main aiims building 4th floor
AIIMS Hostel no. 12. Room no. 208. Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
hsawidd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Diwash Sunar |
| Designation |
Junior Resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
AIIMS, Department of ENT head and neck surgery, Main aiims building 4th floor
AIIMS Hostel no. 12. Room no. 208. Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
hsawidd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Diwash Sunar |
| Designation |
Junior Resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
AIIMS, Department of ENT head and neck surgery, Main aiims building 4th floor
AIIMS Hostel no. 12. Room no. 208. Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
hsawidd@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute Of medical sciences Department of ENT Head and Neck surgery |
| Address |
AIIMS, Ansari nagar, New delhi 110029 |
| 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 Shuchita Singh |
AIIMS |
AIIMS, Dept of ENT head and Neck surgery, Main aiims building, 4th floor
New Delhi
DELHI |
9717278897
drshuch@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committtee, AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J309||Allergic rhinitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nasal douching |
Nasal douching |
| Comparator Agent |
Nasal douching |
Nasal cavity douching will be performed with the subjects kneeling on the ground, neck flexed, and forehead resting on the floor. Five milliliters of solution will be used (1 teaspoon of salt and 1 teaspoon of sodium bicarbonate each in 500 ml of cooled boiled water) and infused into the nasal cavity by way of a syringe or until the nasal cavity is filled. The subject is supposed to hold this position for 2 minutes, after which they should sit upright. Approximately 4 ml of saline would then be recovered into a bowl on return to upright posture. The entire process would be repeated 3 times at one go, twice a day (both morning and evening).
|
|
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Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Valid informed consent to be enrolled in the study
Male or female Age 11 to 60 years
Clinically proven cases of Allergic Rhinitis with deficient serum 25 (OH) Vitamin D level.
|
|
| ExclusionCriteria |
| Details |
Age less than 11 years or more than 60 years
History of any major systemic or local medical illnesses, like Uncontrolled diabetes mellitus, Uncontrolled hypertension, Active tuberculosis, liver diseases, inflammatory conditions or any auto-immune disorder, or local pathologies like nasal polyp or nasal mass
Those who do not give the consent for participation
History of hypersensitivity to steroids
Patients with normal level of Serum 25 (OH) Vitamin D level or on supplements
Pregnant woman and lactating mothers
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| decrease in SNOT 22 score |
Baseline and after 3 months of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| decrease in Absolute eosinophil count |
3 months |
|
|
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)
|
10/02/2022 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study would be conducted in the Departments of
Otorhinolaryngology and Head Neck Surgery, Hematology and Endocrinology, AIIMS,
New Delhi.
Our study sample would comprise of 100 patients of
allergic rhinitis who would be recruited from the patients
attending ENT OPD, AIIMS for allergic rhinitis. we would recruit
those who fit the inclusion / exclusion criteria and would be willing to
participate in the study.
|