| CTRI Number |
CTRI/2024/07/070568 [Registered on: 13/07/2024] Trial Registered Prospectively |
| Last Modified On: |
12/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
Sodium Alginate antacid combination on quality of life, Tolerability and effectiveness in GERD patients |
|
Scientific Title of Study
|
A Real World Evidenced Study to understand the effect Sodium Alginate antacid combination on quality of life, Tolerability and effectiveness in GERD patients |
| 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 Dinesh Patil MBBS MD |
| Designation |
General Manager Medical Services |
| Affiliation |
Alembic Pharmaceuticals Limited |
| Address |
Department of Medical Services, 2nd floor, Prime Corporate Park, Alembic Pharmaceuticals Ltd, Behind ITC Grand Maratha Sheraton, Sahar Road, Andheri (E)
Mumbai (Suburban) MAHARASHTRA 400099
India
Mumbai (Suburban)
MAHARASHTRA
400099
India |
| Phone |
9823953957 |
| Fax |
|
| Email |
dinesh.patil@alembic.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dinesh Patil MBBS MD |
| Designation |
General Manager Medical Services |
| Affiliation |
Alembic Pharmaceuticals Limited |
| Address |
Department of Medical Services, 2nd floor, Prime Corporate Park, Alembic Pharmaceuticals Ltd, Behind ITC Grand Maratha Sheraton, Sahar Road, Andheri (E)
Mumbai (Suburban) MAHARASHTRA 400099
India
Mumbai (Suburban)
MAHARASHTRA
400099
India |
| Phone |
9823953957 |
| Fax |
|
| Email |
dinesh.patil@alembic.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dinesh Patil MBBS MD |
| Designation |
General Manager Medical Services |
| Affiliation |
Alembic Pharmaceuticals Limited |
| Address |
Department of Medical Services, 2nd floor, Prime Corporate Park, Alembic Pharmaceuticals Ltd, Behind ITC Grand Maratha Sheraton, Sahar Road, Andheri (E)
Mumbai (Suburban) MAHARASHTRA 400099
India
Mumbai (Suburban)
MAHARASHTRA
400099
India |
| Phone |
9823953957 |
| Fax |
|
| Email |
dinesh.patil@alembic.co.in |
|
|
Source of Monetary or Material Support
|
| Alembic Pharmaceuticals Ltd. Prime Corporate Park, Behind ITC Grand Maratha Sheraton, Sahar Road, Andheri (E), Mumbai - 400 099 |
|
|
Primary Sponsor
|
| Name |
Alembic Pharmaceuticals Ltd. |
| Address |
Alembic Pharmaceuticals Ltd. 2nd floor, Prime Corporate Park, Behind ITC Grand Maratha Sheraton, Sahar Road, Andheri (E), Mumbai - 400 099 |
| 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 Dinesh Patil |
Alembic Pharmaceuticals Limited |
Alembic Pharmaceuticals Ltd.2nd Floor , Prime Corporate Park, Behind ITC Grand Maratha Sheraton, Sahar Road, Andheri East, Mumbai, 400099
Mumbai (Suburban)
MAHARASHTRA |
9823953957
dinesh.patil@alembic.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INDEPENDENT ETHICS COMMITTEE DHANASHREE HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K210||Gastro-esophageal reflux disease with esophagitis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Ages: ≥ 18 years
2. Genders Eligible for Study: both Males and Females
3. Patients who received oral Sodium alginate antacid suspension in the past for the
management of GERD as per the local prescription data.
|
|
| ExclusionCriteria |
| Details |
Patients those who had not received sodium alginate antacid suspension as per the local
prescription data
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of GERD patient achieving improvement in the quality of life |
Proportion of GERD patient having treatment related side effects on day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy and safety profile of the patient who had
received sodium alginate antacid
|
To evaluate the efficacy and safety profile of the patient who had
received sodium alginate antacid
|
| Proportion of GERD patient having treatment related side effects on day 7 |
From the Baseline to the 7 day after the treatment initiation |
|
|
Target Sample Size
|
Total Sample Size="10000"
Sample Size from India="10000"
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)
|
30/07/2024 |
| 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="3"
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 is a Retrospective observational real world evidence data retrieval study planned with an objective to understand the effect of sodium Alginate combination on quality of life , Tolerability and effectiveness on Gerd patients were received in the past .This retrospective data retrieval study will conducted across pan India centers. The overall data
retrieval for this study is 10,000 patients who had received Sodium Alginate antacid suspension for the treatment of
GERD.The data retrieval of the medical record form were done from the physician of the patients
who had received Sodium alginate antacid for the treatment of GERD. |