| CTRI Number |
CTRI/2025/11/097101 [Registered on: 07/11/2025] Trial Registered Prospectively |
| Last Modified On: |
04/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Awareness and Benefits of Using Peak Flowmeters Among Asthmatic Patients of age between 6 years to 18 years age group for Better Disease Monitoring of Asthma |
|
Scientific Title of Study
|
Awareness about usefulness of peak flowmeter for Asthma monitoring |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mrugank Chandure |
| Designation |
Resident medical officer |
| Affiliation |
Shyam Shah Medical College |
| Address |
Department of Pediatrics, SSMC medical college, Rewa
Rewa
MADHYA PRADESH
486001
India |
| Phone |
7710966507 |
| Fax |
|
| Email |
chanduremrugank@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shabd Singh Yadav |
| Designation |
Professor |
| Affiliation |
Shyam Shah Medical College |
| Address |
Department of Pediatrics, SSMC medical college, Rewa
Rewa
MADHYA PRADESH
486001
India |
| Phone |
9827260904 |
| Fax |
|
| Email |
sshabd@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shabd Singh Yadav |
| Designation |
Professor |
| Affiliation |
Shyam Shah Medical College |
| Address |
Department of Pediatrics, SSMC medical college, Rewa
Rewa
MADHYA PRADESH
486001
India |
| Phone |
9827260904 |
| Fax |
|
| Email |
sshabd@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatric, SSMC, REWA,486001 |
|
|
Primary Sponsor
|
| Name |
Dr Mrugank Chandure |
| Address |
Department of Pediatrics, SSMC medical college, Rewa |
| Type of Sponsor |
Other [self] |
|
|
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 Shabd Singh Yadav |
PICU, Pediatric ward |
Department of Pediatrics, SSMC medical college, Rewa
Rewa
MADHYA PRADESH |
9827260904
sshabd@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, S.S Medical College, Rewa (M.P) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J453||Mild persistent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No monitoring by peak flow meter |
compared with 1month of historical data when monitoring was not done |
| Intervention |
Peak flow meter |
peak flow meter monitoring twice daily for one month |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children diagnosed with asthma in age group of 6 years to 18 years on MDI therapy |
|
| ExclusionCriteria |
| Details |
children with chronic illness
cystic fibrosis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| increase awareness about Peak flow meter monitoring in asthma |
6 months to 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to find outcome in view of acute asthma attacks and no of time of hospitalization |
6 months to 1 year |
|
|
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)
|
20/11/2025 |
| 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="0"
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
|
This study aimed to increase awareness of peak flow meter uses in asthma monitoring in children within age group of 6 yrs to 18 yrs with known case of asthma. It was a single arm type of clinical trial conducted at Department of pediatrics, SSMC Rewa. A total 100 children with known case of asthma which are on MDI were taken for study, brief history of acute attacks of asthma are taken from hospital data for all children and then details information given about peak flow meter, how to use it and ask to maintain asthma diary for next one month. Outcome were measured by comparing number of acute severe asthma attacks and number of hospitalizations before and after use of peak flow meter. |