| CTRI Number |
CTRI/2025/08/093440 [Registered on: 21/08/2025] Trial Registered Prospectively |
| Last Modified On: |
10/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
improvment in liver enzymes and symptoms in patients with cholestasis of pregnancy after ursodeoxycholic acid therapy
|
|
Scientific Title of Study
|
BIOCHEMICAL MILIEU IN INTRAHEPATIC CHOLESTASIS OF PREGNANCY
AND ITS IMPROVEMENT WITH URSODEOXYCHOLIC ACID
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RUCHI PATEL |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
MLN MEDICAL COLLEGE ALLAHABAD |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY MLN MEDICAL COLLEGE ALLAHABAD
Allahabad
UTTAR PRADESH
211001
India |
| Phone |
7011466059 |
| Fax |
|
| Email |
ruchidhiru11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
somya saxena |
| Designation |
Assistant proffessor |
| Affiliation |
MLN MEDICAL COLLEGE ALLAHABAD |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY MLN MEDICAL COLLEGE ALLAHABAD
Allahabad
UTTAR PRADESH
211001
India |
| Phone |
|
| Fax |
|
| Email |
dhrndrsngh11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RUCHI PATEL |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
MLN MEDICAL COLLEGE ALLAHABAD |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY MLN MEDICAL COLLEGE ALLAHABAD
Allahabad
UTTAR PRADESH
211001
India |
| Phone |
7011466059 |
| Fax |
|
| Email |
ruchidhiru11@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
MLN MEDICAL COLLEGE ALLAHABAD |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY |
| Type of Sponsor |
Government medical college |
|
|
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 |
| RUCHI PATEL |
MLN MEDICAL COLLEGE ALLAHABAD |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGYMLN MEDICAL COLLEGE ALLAHABAD
Allahabad
UTTAR PRADESH |
07011466059
ruchidhiru11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee mln medical college and associate hospitals prayagraj |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O266||Liver and biliary tract disordersin pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
URSODEOXYCHOLIC ACID |
ursodeoxycholic acid with dose of 300 mg twice a day continue till delivery or until lft comes within normal limit repeat samples were sent on 7th and 14th day for assessing the improvement in Liver function test. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women in late 2nd (26-28 weeks) and 3rd trimester with Intrahepatic cholestasis of pregnancy. |
|
| ExclusionCriteria |
| Details |
1.Preeclampsia, eclampsia
2.Acute fatty liver of pregnancy
3.Viral hepatitis (HAV, HBV, HCV, HEV).
4.Liver cirrhosis, tumors
5.Autoimmune liver disease.
6.Obstructive biliary disease.
• Known kidney diseases.
• Dermatoses of pregnancy- Gestational pemphigoid, pruritic and urticarial papules and plaques (PUPPP), atopic eruption of pregnancy i.e., eczema and prurigo.
• Impetigo herpetiformis- triggered by pregnancy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To establish the effect of ursodeoxycholic acid in the liver biochemical markers [Serum bile acid, Serum bilirubin, serum liver transaminases (ALT, AST), alkaline phosphatase] in Patients of IHCP. |
1 week and 2weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the perinatal outcome after ursodeoxycholic acid therapy in IHCP |
1 week & 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
12/09/2025 |
| 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="0"
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 - NO
|
|
Brief Summary
|
Intrahepatic
cholestasis of pregnancy (IHCP) or obstetric cholestasis is the pregnancy related liver disorder more
commonly occurring in late second and third trimester of pregnancy. Ursodeoxycholic acid (UDCA) is a secondary
bile acid synthesized in humans by intestinal bacteria. It is the most
effective medical treatment. This
study is being done to see the response
after therapy in the form of symptomatic and biochemical relief at 7th
and 14th days of treatment with ursodeoxycholic acid and thereafter
fortnightly and they followed till delivery to assess the feto-maternal outcome |