| CTRI Number |
CTRI/2024/05/067435 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
01/09/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Educational Intervention] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Educational Pharmaceutical Care program for Newly Diagnosed Diabetes Mellitus Patients. |
|
Scientific Title of Study
|
Integrated Pharmaceutical Care Programme in Patients with Diabetes Mellitus An Interventional Cross Sectional Prospective Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rishita Patel |
| Designation |
Assistant professor |
| Affiliation |
INDUKAKA IPCOWALA COLLEGE OF PHARMACY |
| Address |
INDUKAKA IPCOWALA COLLEGE OF PHARMACY
Department of Pharmacology
Vithal Udyognagar
Beyond GIDC
Phase IV
New Vallabh Vidyanagar
Post Box No 53
Vitthal Udyognagar
388 121
Anand Gujarat
Anand
GUJARAT
388120
India |
| Phone |
7600335126 |
| Fax |
- |
| Email |
rishita.patel@cvmu.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harsha Patel |
| Designation |
Principal |
| Affiliation |
INDUKAKA IPCOWALA COLLEGE OF PHARMACY |
| Address |
INDUKAKA IPCOWALA COLLEGE OF PHARMACY
Vithal Udyognagar
Beyond GIDC
Phase IV
New Vallabh Vidyanagar
Post Box No 53
Vitthal Udyognagar
388 121
Anand Gujarat
Anand
GUJARAT
388120
India |
| Phone |
8758149590 |
| Fax |
- |
| Email |
harshaben.patel@cvmu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Rishita Patel |
| Designation |
Assistant professor |
| Affiliation |
INDUKAKA IPCOWALA COLLEGE OF PHARMACY |
| Address |
INDUKAKA IPCOWALA COLLEGE OF PHARMACY
Department Of Pharmacology
Vithal Udyognagar
Beyond GIDC
Phase IV
New Vallabh Vidyanagar
Post Box No 53
Vitthal Udyognagar
388 121
Anand Gujarat
GUJARAT
388120
India |
| Phone |
7600335126 |
| Fax |
- |
| Email |
rishita.patel@cvmu.edu.in |
|
|
Source of Monetary or Material Support
|
| Saarathi Institute of
Diabetes Sciences
Ground Floor Behind Uma Bhavan Anand
Sojitra Road Borsad Crossing Anand
Gujarat 388001
INDIA |
| Self sponsored
Rishita D Patel
Indukaka Ipcowala College of Pharmcay
ANAND
388121
GUJARAT
INDIA |
|
|
Primary Sponsor
|
| Name |
Rishita Patel |
| Address |
Indukaka Ipcowala College Of Pharmacy
Vithal Udyognagar Beyond GIDC Phase IV
New Vallabh Vidyanagar
Post Box No 53
Vitthal Udyognagar
388 121
Anand
GUJARAT
388120
India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Alpa Gor |
Pramukhswami Medical College |
Department of Pharmacology
Incharge Mentorship Programme
Pramukhswami Medical College
Bhaikaka University
Karamsad
Anand
GUJARAT |
9924115170
-
alpagor15@gmail.com |
| Dr Chintan Vyas |
Saarathi Institute Of Diabetes Sciences |
SIDS
Ground Floor
Behind Uma Bhavan Anand Sojitra Road
Borsad Crossing
Anand
Gujarat
388001
Anand
GUJARAT |
9879577370
-
drchintanv@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE-2 Bhaikaka University Karamsad anand Gujarat |
Approved |
| NA |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Give Education and councelling |
formulation and intervention of working model of Diabetes mellitus educational pharmaceutical care for 4 times during 16 month time period.
every 4 month follow up date will be given to participants. |
| Comparator Agent |
No Education and councelling |
NO formulation and not interventional working model of Diabetes mellitus educational pharmaceutical care given to this group
only conventional care given by physician. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Type-II diabetes mellitus.
Patients with HbA1c more than 7%.
Patients who receiving oral hypoglycemic and/or insulin therapy.
Patients who provide written informed consent.
Patients who express willingness to participate in the study.
|
|
| ExclusionCriteria |
| Details |
Patients who are younger than 18 years (They are legally regarded as dependents and consequently they cannot take decisions of their own).
Pregnant Women.
Patients who will not willing to give consent to participate.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in HbA1C levels in intervention group |
Reduction in HbA1C levels exactly after 4 Times in each 4 month intervention during 16 month study period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
enhancing patients quality of life in the form of reduction of symptoms
improving self-management of disease & achieving goal of health promotion & prevention of progression of diabetes mellitus |
exactly 4 times( each 4 months) Intervention during 16 months study period |
|
|
Target Sample Size
|
Total Sample Size="282"
Sample Size from India="282"
Final Enrollment numbers achieved (Total)= "280"
Final Enrollment numbers achieved (India)="280" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
27/05/2024 |
| Date of Study Completion (India) |
29/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
29/09/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Primary Purpose of study
In
India very few studies done on proposed research problem. Since 1990 to
2022, 15 research were found in PubMed, Scopus, Web of science and Ovid Medline
from India.
In
India these epidemiological studies were carried out from south India Mumbai
and North India. There is only two supportive research found from Gujarat state
but it was only focused on KAP not a pharmaceutical care program.
In
this field, this will be structured interventional pharmaceutical care research
carried out in Gujarat, rather than unstructured conventional method. This study adds the variability of data
from Gujarat state of India.
Previous
research was mostly focused on out impact of education on patients KAP and QOL
parameters and not every research was focused on HbA1c parameter. This research
will be found out impact of education on patients HbA1c level.
Addition
to KAP and QOL this study will find out diabetes distress levels, Adherence levels,
cost of illness, Drug related problems and satisfaction level of patients
towards pharmaceutical care from Gujarat, India.
Proposed Hypothesis of Study
Summary
This proposed research work is based on formulation and intervention of working
model of Diabetes mellitus educational pharmaceutical care.
Outcome of this research will be improving knowledge and understanding of
disease and enhancing self-management of disease among the patients.
By application of timely education and follow up, adherence of treatment
and self-regulatory behavior will be enhanced and this will optimize the use of
medicines.
Mostly the primary outcome of this research that will be reduction in
HbA1C levels in intervention group.
Ultimate outcome of proposed study will be enhancing patients’ quality of
life in the form of reduction of symptoms, improving self-management of disease
and achieving goal of health promotion and prevention of progression of
diabetes mellitus.
|