| CTRI Number |
CTRI/2026/02/103367 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
06/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
STUDY ON PATIENTS WITH PORTAL HYPERTENSION : CLINICAL PROFILE AND UPPER GASTROINTESTINAL TRACT ENDOSCOPIC FINDINGS |
|
Scientific Title of Study
|
STUDY ON ETIOLOGY, CLINICAL PROFILE AND UPPER GASTROINTESTINAL TRACT ENDOSCOPIC FINDINGS IN PATIENTS WITH PORTAL HYPERTENSION |
| 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 Sadaf Khan |
| Designation |
Junior Resident |
| Affiliation |
Dr D.Y. Patil Medical College, Hospital and Research Center |
| Address |
Department of General Medicine, Dr D.Y. Patil Medical College, Hospital and Research Center Sector 5, Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
7303407220 |
| Fax |
|
| Email |
Sadafkhan945@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santwana Chandrakar |
| Designation |
Professor and Head of Unit General Medicine |
| Affiliation |
Dr D.Y. Patil Medical College, Hospital and Research Center |
| Address |
Department of General Medicine, Dr D.Y. Patil Medical College, Hospital and Research Center Sector 5, Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9820505489 |
| Fax |
|
| Email |
Santwana.chandrakar@dypatil.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sadaf Khan |
| Designation |
Junior Resident |
| Affiliation |
Dr D.Y. Patil Medical College, Hospital and Research Center |
| Address |
Department of General Medicine, Dr D.Y. Patil Medical College, Hospital and Research Center Sector 5, Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
7303407220 |
| Fax |
|
| Email |
Sadafkhan945@gmail.com |
|
|
Source of Monetary or Material Support
|
| Padmashree Dr D Y Patil Medical College, Hospital and Research Center,
Sector-5, Nerul, Navi Mumbai |
|
|
Primary Sponsor
|
| Name |
Dr Sadaf Khan |
| Address |
Padmashree Dr D Y Patil Medical College, Hospital and Research Center,
Sector-5, Nerul, Navi Mumbai |
| 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 Sadaf Khan |
Padmashree Dr D Y Patil Medical College, Hospital and Research Center, Sector-5, Nerul, Navi Mumbai |
In patient department including Male medicine ward and Female medicine ward, Out patient department, Emergency Department , Gastroentrology Department,Intensive care unit
Dr D Y Patil Medical College, Hospital and Research Center,
Sector-5, Nerul, Navi Mumbai
Thane
MAHARASHTRA |
7303407220
Sadafkhan945@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee for Biomedical and Health Research (IECBH) of Dr D Y Patil Medical College & Hospital, Navi Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K721||Chronic hepatic failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Clinical criteria :
1.Patients above 18 years of age of both genders.
2.Patients diagnosed with portal hypertension based
on clinical , radiological and endoscopic findings.
3.Patient giving consent for study.
|
|
| ExclusionCriteria |
| Details |
1.Patients unwilling for the study.
2. Patients below 18 years.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Study etiological, Clinical Features of patients presenting with portal hypertension |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Study etiological, Clinical Features, biochemical parameters & endoscopic findings of patients presenting with portal hypertension |
1 year |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
20/02/2026 |
| 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="0"
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
|
The aim of this study:
A need is felt to undertake present study for generating data on
various aspects of problems encountered in day to day practice in a
referral centre to establish early diagnosis of the etiology, exact site
and nature of the bleed and rational management to improve the
overall outcome of the disease.
Main Objectives
1. To Study etiological, Clinical Features, biochemical
parameters of patients presenting with portal hypertension
2. To evaluate Upper Gatrointestinal Endoscopic findings in
portal hypertension
3. Correlation of clinical profile and investigations of these
patients
|