| CTRI Number |
CTRI/2022/11/047589 [Registered on: 23/11/2022] Trial Registered Prospectively |
| Last Modified On: |
17/11/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Questionnaire based Study |
| Study Design |
Other |
|
Public Title of Study
|
A survey to assess the responses of paediatricians in treatment of Functional Abdominal Pain (FAP)
|
|
Scientific Title of Study
|
To Assess Knowledge, Attitude, and Practice (KAP) among
Pediatricians for Functional Abdominal Pain (FAP) in Children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DRL-IND-GGI-015-KAPP/2022 Version 1.0 date 18-Oct-2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Krishna Chaitanya Veligandla |
| Designation |
Principal Investigator |
| Affiliation |
Dr. Reddys Laboratories Ltd. |
| Address |
8-2-337, Road No. 3
Banjara Hills, Hyderabad
Telangana-500034, India
Hyderabad
TELANGANA
500034
India |
| Phone |
9652274423 |
| Fax |
|
| Email |
drkrishnachaitanya1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krishna Chaitanya Veligandla |
| Designation |
Principal Investigator |
| Affiliation |
Dr. Reddys Laboratories Ltd. |
| Address |
8-2-337, Road No. 3
Banjara Hills, Hyderabad
Telangana-500034, India
TELANGANA
500034
India |
| Phone |
9652274423 |
| Fax |
|
| Email |
drkrishnachaitanya1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krishna Chaitanya Veligandla |
| Designation |
Principal Investigator |
| Affiliation |
Dr. Reddys Laboratories Ltd. |
| Address |
8-2-337, Road No. 3
Banjara Hills, Hyderabad
Telangana-500034, India
TELANGANA
500034
India |
| Phone |
9652274423 |
| Fax |
|
| Email |
drkrishnachaitanya1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Reddys Laboratories Ltd.
|
|
|
Primary Sponsor
|
| Name |
Dr. Reddys Laboratories Ltd. |
| Address |
8-2-337, Road No. 3
Banjara Hills, Hyderabad
Telangana-500034, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Krishna Chaitanya Veligandla |
Dr. Reddys Laboratories Ltd. |
8-2-337, Road No. 3
Banjara Hills, Hyderabad
Telangana-500034, India
Hyderabad
TELANGANA |
9652274423
drkrishnachaitanya1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Royal Pune Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K929||Disease of digestive system, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Pediatric practitioners who provide care to patients with FAP in healthcare
setups/clinics/hospitals/colleges located across various regions of India (no
minimum experience required)
2. Indian pediatricians with MD, DCH, or DNB degree
3. Pediatricians willing to participate in the study |
|
| ExclusionCriteria |
| Details |
1. Pediatricians not treating patients with FAP |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the knowledge, attitude, and practice of primary care pediatric practitioners
regarding pathophysiology, diagnosis, and evidence-based treatment for FAP and
related symptoms in children |
Visit 1 - Day 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
25/11/2022 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a survey conducted amongst paediatricians using a questionnaire to assess the knowledge, attitude and practice of these paediatricians for diagnosis and treatment of functional abdominal pain in children. No individual patient information is collected in this study. |