| CTRI Number |
CTRI/2024/02/062996 [Registered on: 21/02/2024] Trial Registered Prospectively |
| Last Modified On: |
09/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Symptomatic outcome of pancreatic enzyme replacement therapy in cases of pancreatic exocrine insufficiency |
|
Scientific Title of Study
|
Outcome of post pancreatic enzyme replacement therapy in patients of pancreatic exocrine insufficiency |
| 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 SOMYA GOEL |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Jawaharlal Nehru Medical College Sawangi(Meghe), Wardha |
| Address |
Dept of general surgery, smsc building fourth floor, Jawaharlal Nehru Medical College
Sawangi(Meghe) Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
|
| Fax |
|
| Email |
somyagoel98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr RK SHINDE |
| Designation |
professor |
| Affiliation |
Jawaharlal Nehru Medical College, Sawangi(Meghe), Wardha |
| Address |
Dept of general surgery, smsc building fourth floor, Jawaharlal Nehru Medical College
Sawangi(Meghe) Wardha
Wardha
MAHARASHTRA
452001
India |
| Phone |
8087148087 |
| Fax |
|
| Email |
raju.shinde95@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr RK SHINDE |
| Designation |
professor |
| Affiliation |
Jawaharlal Nehru Medical College, Sawangi(Meghe), Wardha |
| Address |
Dept of general surgery, smsc building fourth floor, Jawaharlal Nehru Medical College
Sawangi(Meghe) Wardha
Wardha
MAHARASHTRA
452001
India |
| Phone |
8087148087 |
| Fax |
|
| Email |
raju.shinde95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education & Research SAWANGI (MEGHE) |
|
|
Primary Sponsor
|
| Name |
Dr Somya Goel |
| Address |
Jawaharlal Nehru Medical College,
Sawangi(Meghe), Wardha
|
| 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 SOMYA GOEL |
Acharya Vinoba Bhave Rural hospital |
DEPT OF GENERAL SURGERY, DMIHER, SAWANGI (MEGHE)
442001
Wardha
MAHARASHTRA |
7869910553
somyagoel98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe institute of higher education,INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Clinically confirmed case of acute and chronic pancreatitis with exocrine insufficiency in patients above 18 years of age
Patients with Baltahazar CT severity index of 2 and more
|
|
| ExclusionCriteria |
| Details |
Other pancreatic pathology like pancreatic malignancy, cyst.
Contraindicated cases for contrast ct study.
Patients where quality of life cannot be assessed
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assess reduction in pain, bloating and sticky stool and weight changes post pancreatic enzyme replacement therapy in patients of pancreatic exocrine insufficiency
|
0 days 15 days 45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Grading of complaints of pain on the basis of ‘visual analogue scale’
Grading of CT scan findings based on Baltahazar CT severity index
Documentation of weight changes pre and post therapy using same standard weighing scale .
General improvement in clinical symptoms and lifestyle changes will be assessed through WHO quality of life scale
Regular follow up at 0 days – 15 days – 45 days to check compliance towards therapy will be done first hand using Morisky Medication Adherence Scale (MMAS-8)
|
16 MONTHS TO 34 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
21/02/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
21/02/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="5"
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
|
An observational study for
patients suffering from pancreatic exocrine insufficiency
undergoiong pancreatic enzyme replacement therapy. Well informed
consent will be obtained for inclusion in study and publication of study ,Relevant
details will be collected related to clinical symptoms signs duration onset
other co morbidities history of diet alcohol consumption and smoking
multiple parameters including pain assessed by visual analogue scale, Grading
of CT scan findings based on Baltahazar CT severity index Documentation
of weight changes pre and post therapy using same standard weighing scale . General
improvement in clinical symptoms and lifestyle changes will be assessed through
WHO quality of life scale Regular
follow up at 0 days – 15 days – 45 days to check compliance towards therapy
will be done first hand using Morisky Medication Adherence Scale
(MMAS-8) A
standard proforma will be used to record patient data and informed consent will
be obtained from the patients before enrolment to the study for inclusion and
publication.
|