| CTRI Number |
CTRI/2025/01/078868 [Registered on: 16/01/2025] Trial Registered Prospectively |
| Last Modified On: |
31/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Protein Analysis in patients with Chronic Pancreatitis |
|
Scientific Title of Study
|
Proteomic Profiling of Patients with Chronic Pancreatitis Following Genistein (Soybean Extract) Administration: A 6-Month Study on Pain-Associated Biomarkers |
| 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 Rajiv Mehta |
| Designation |
Director & Consultant Gastroenterologist |
| Affiliation |
SIDS hospital and research centre |
| Address |
SIDS healthcare private limited Majura-Khatodara Bamroli road, Khatodara Near Shell petrol pump Majuragate
Surat
GUJARAT
395002
India |
| Phone |
9909907475 |
| Fax |
|
| Email |
rmgastro@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhvani Adhvaryu |
| Designation |
Research Coordinator |
| Affiliation |
SIDS hospital and research centre |
| Address |
SIDS healthcare private limited Majura-Khatodara Bamroli road, Khatodara Near Shell petrol pump Majuragate
Surat
GUJARAT
395002
India |
| Phone |
9925849900 |
| Fax |
|
| Email |
dhvaniadhvaryu21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Samir Vanani |
| Designation |
General Medical Practitioner |
| Affiliation |
SIDS hospital and research centre |
| Address |
SIDS healthcare private limited Majura-Khatodara Bamroli road, Khatodara Near Shell petrol pump Majuragate
Surat
GUJARAT
395002
India |
| Phone |
9662179254 |
| Fax |
|
| Email |
samir.vanani@outlook.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SIDS Hospital and Research Center |
| Address |
SIDS healthcare private limited Majura Khatodara Bamroli Road
Near Shell petrol pump Majuragate Surat 395002
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 Rajiv Mehta |
SIDS Hospital and Research Center |
Majura-Khatodara Bamroli road
Khatodara Near Shell petrol pump Majuragate. Department of Gastroenterology, Room number 13
Surat
GUJARAT |
9909907475
rmgastro@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SIDS Hospital and Research Centre EC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K861||Other chronic pancreatitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1: Genistein-treatment arm |
(500mg; twice daily) for 6 months |
| Comparator Agent |
Group 2: Placebo-control arm |
(Matching placebo; twice daily) for 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patients (18-65 years) with a diagnosis of chronic pancreatitis.
2. Persistent pancreatic pain (intermittent or continuous).
3. No history of pancreatic surgery or pancreatic cancer.
4. Willingness to comply with trial procedures and provide consent
|
|
| ExclusionCriteria |
| Details |
1. History of autoimmune pancreatitis or biliary pancreatitis.
2. Severe chronic pancreatitis (e.g.,Cambridge Classification Grade IV).
3. Any active infections, recent severe illness, or psychiatric disorders.
4. Concurrent use of other investigational drugs.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Evaluation of blood biomarkers related to inflammation, stress, fibrosis, and pancreatic regeneration |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Health-Related Quality of Life (HRQoL) as assessed by Patient-Reported Outcomes using phone-based application from baseline (week 0) to end of treatment (week 24). |
6 months |
| Pain Score Assessment: Regular measurement using a validated pain score (e.g., Visual Analogue Scale (VAS) at pre-defined intervals. |
6 months |
| Change in analgesic use from baseline (week 0) to end of the treatment (week 24). |
6 months |
| Any readmissions for recurrent attacks of pancreatitis from baseline (week 0) to end of the treatment (week 24). |
6 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
|
Phase 2 |
|
Date of First Enrollment (India)
|
04/02/2025 |
| 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="6"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (NA).
- For how long will this data be available start date provided 03-05-2027 and end date provided 04-05-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This is a single-center randomized, study designed
to assess Proteomic Profiling of Patients on
Genistein over 24 weeks with chronic pancreatitis (CP). The primary objective
is to to evaluate the proteomic changes and pain outcomes in patients with
chronic pancreatitis. Secondary objectives include Change in Health-Related
Quality of Life (HRQoL) as assessed
by Patient-Reported Outcomes using phone-based application from baseline (week 0) to the end of treatment
(week 24), pain score monitoring using VAS, hospital admission rates due to recurrent episodes, and analgesic use comparison between
Genistein and placebo arm. |