Hepatitis AAVHNCT07525401
Comparative Evaluation of Oral Ursodeoxycholic Acid in Reducing Bilirubin Levels Among Patients With Acute Viral Hepatitis
A study testing Ursodeoxycholic Acid and Supportive Care in people with Hepatitis A and Hepatitis E Virus Infection, run by Combined Military Hospital, Pakistan.
Trial summary
Hepatitis is an inflammatory condition of the liver that has emerged as a significant global health concern due to its widespread prevalence. Data on ursodeoxycholic acid in acute viral hepatitis remain limited. Some studies suggest its positive effect in cholestatic phase of viral hepatitis. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Hepatitis A, Hepatitis E Virus Infection
- What is being tested?
- Ursodeoxycholic Acid and Supportive Care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All patients of either gender
- aged >18 years to 50 years with acute viral hepatitis are included
Who cannot join
- Patients having Hepatitis B, C
- hepatocellular carcinoma
- primary biliary cholangitis
- choldocholithiasis
- patients having normal bilirubin levels with AVH were excluded.
About this study
Hepatitis is an inflammatory condition of the liver that has emerged as a significant global health concern due to its widespread prevalence.
Data on ursodeoxycholic acid in acute viral hepatitis remain limited. Some studies suggest its positive effect in cholestatic phase of viral hepatitis. UDCA may reduce cholestatic symptoms like jaundice and pruritus potentially shortening hospital stay and improving patient outcomes. However, robust clinical data supporting its routine use in acute viral hepatitis are lacking, and current treatment remains largely supportive. Given the high burden of acute viral hepatitis in our region and the potential for UDCA to improve cholestatic phase of AVH there is a clear need for well-designed clinical studies evaluating its therapeutic role. This study aims to evaluate the role of oral ursodeoxycholic acid in biochemical recovery of patients with acute viral hepatitis. If positive role is confirmed, it will be incorporated in standard treatment and if no role is found unnecessary use will be discouraged.
Read more
Null Hypothesis (H₀):
Oral ursodeoxycholic acid has no significant effect on the bilirubin levels of patients with acute viral hepatitis.
H₀: There is no statistically significant difference in bilirubin levels between patients receiving ursodeoxycholic acid and those receiving supportive care alone.
Alternative Hypothesis (H₁):
Oral ursodeoxycholic acid reduces bilirubin levels in patients with acute viral hepatitis. H₁: There is statistically significant difference in bilirubin levels between patients receiving ursodeoxycholic acid and those receiving supportive care alone.
Read the detailed description
Study design: A Quasi-experimental design There is an intervention group (receiving UDCA + standard care) and a control group (receiving standard care only) Study Setting: Medicine department of Combined Military Hospital, Malir, Karachi Study Duration: 6 months Sampling Technique: Non probability consecutive sampling technique
Sample Size:
Open Epi version 3, was used to calculate the sample size with a two-sided 95% confidence interval and 80% power. This was based on an expected mean difference of 0.3 mg/dL in bilirubin levels between the treatment group (mean = 4.1 mg/dL, SD = 0.5) and the control group (mean = 3.8 mg/dL, SD = 0.5) (6), a minimum of 44 participants per group was calculated to detect this difference, assuming equal variances and group sizes. The total sample size is calculated to be 88 (total N = 88), with 44 participants in each group.
Since the total estimated number of eligible admissions during the study period was 200 and the required sample size was 88, a sampling interval (k) of approximately 2 was calculated (k = 200/88 ≈ 2). A random starting point was selected to avoid periodic bias, and thereafter every 2nd eligible patient was included until the desired sample size was achieved.
Inclusion Criteria All patients of either gender, aged >18 years to 50 years with acute viral hepatitis are included.
Exclusion Criteria Patients having Hepatitis B, C, hepatocellular carcinoma, primary biliary cholangitis, choldocholithiasis and patients having normal bilirubin levels with AVH were excluded.
- Conditions
- Hepatitis A, Hepatitis E Virus Infection
- Being tested
- Ursodeoxycholic Acid, Supportive Care
- Keywords
- Acute viral hepatitis, Ursodeoxycholic acid, UDCA, Hepatitis A, Hepatitis E
- Medical subject headings
- Hepatitis A, Hepatitis E
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ursodeoxycholic AcidDrug
Also called UDCA
For UDCA Arm Ursodeoxycholic acid administered orally at a dose of 10 mg/kg/day in 2 divided doses for 7 days, in addition to standard supportive care, for patients with acute viral hepatitis fulfilling inclusion criteria
*standard supportive management including hydration and antiemetics.
For Control Arm Patients receive standard supportive care for acute viral hepatitis without administration of ursodeoxycholic acid.
Supportive CareOther
Standard supportive treatment including hydration, antiemetics, and monitoring without administration of ursodeoxycholic acid.
| Study group | Role | What they receive |
|---|---|---|
| UDCA | Experimental | Patients receiving ursodeoxycholic acid in addition to standard care
Intervention: Receives: Drug: Ursodeoxycholic Acid |
| Control Group | Active comparator | Supportive management for acute viral hepatitis Receives: Other: Supportive Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum total bilirubin levels
Mean reduction in serum total bilirubin from baseline to Day 7 in patients receiving ursodeoxycholic acid compared to control group
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis AStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A Quasi-experimental design There is an intervention group (receiving UDCA + standard care) and a control group (receiving standard care only) standard care is fluids, anti-emetic medicines like Domperidone
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Combined Military Hospital, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khuld e Neha, Combined Military Hospital, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07525401
- Sponsor's protocol ID
- pending
- Other IDs
- CMH Malir
- Acronym
- AVH
- Status last verified
- Mar 2026
- First submitted
- 31 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Oral Ursodeoxycholic Acid in Reducing Bilirubin Levels Among Patients With Acute Viral Hepatitis
- ClinicalTrials.gov ID
- NCT07525401
- Acronym / sponsor ID
- AVH / pending
- Conditions
- Hepatitis A, Hepatitis E Virus Infection
- Keywords
- Acute viral hepatitis, Ursodeoxycholic acid, UDCA, Hepatitis A, Hepatitis E
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Combined Military Hospital, PakistanUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hepatitis is an inflammatory condition of the liver that has emerged as a significant global health concern due to its widespread prevalence.
Data on ursodeoxycholic acid in acute viral hepatitis remain limited. Some studies suggest its positive effect in cholestatic phase of viral hepatitis. UDCA may reduce cholestatic symptoms like jaundice and pruritus potentially shortening hospital stay and improving patient outcomes. However, robust clinical data supporting its routine use in acute viral hepatitis are lacking, and current treatment remains largely supportive. Given the high burden of acute viral hepatitis in our region and the potential for UDCA to improve cholestatic phase of AVH there is a clear need for well-designed clinical studies evaluating its therapeutic role. This study aims to evaluate the role of oral ursodeoxycholic acid in biochemical recovery of patients with acute viral hepatitis. If positive role is confirmed, it will be incorporated in standard treatment and if no role is found unnecessary use will be discouraged.
Null Hypothesis (H₀):
Oral ursodeoxycholic acid has no significant effect on the bilirubin levels of patients with acute viral hepatitis.
H₀: There is no statistically significant difference in bilirubin levels between patients receiving ursodeoxycholic acid and those receiving supportive care alone.
Alternative Hypothesis (H₁):
Oral ursodeoxycholic acid reduces bilirubin levels in patients with acute viral hepatitis. H₁: There is statistically significant difference in bilirubin levels between patients receiving ursodeoxycholic acid and those receiving supportive care alone.
Detailed description
Study design: A Quasi-experimental design There is an intervention group (receiving UDCA + standard care) and a control group (receiving standard care only) Study Setting: Medicine department of Combined Military Hospital, Malir, Karachi Study Duration: 6 months Sampling Technique: Non probability consecutive sampling technique
Sample Size:
Open Epi version 3, was used to calculate the sample size with a two-sided 95% confidence interval and 80% power. This was based on an expected mean difference of 0.3 mg/dL in bilirubin levels between the treatment group (mean = 4.1 mg/dL, SD = 0.5) and the control group (mean = 3.8 mg/dL, SD = 0.5) (6), a minimum of 44 participants per group was calculated to detect this difference, assuming equal variances and group sizes. The total sample size is calculated to be 88 (total N = 88), with 44 participants in each group.
Since the total estimated number of eligible admissions during the study period was 200 and the required sample size was 88, a sampling interval (k) of approximately 2 was calculated (k = 200/88 ≈ 2). A random starting point was selected to avoid periodic bias, and thereafter every 2nd eligible patient was included until the desired sample size was achieved.
Inclusion Criteria All patients of either gender, aged >18 years to 50 years with acute viral hepatitis are included.
Exclusion Criteria Patients having Hepatitis B, C, hepatocellular carcinoma, primary biliary cholangitis, choldocholithiasis and patients having normal bilirubin levels with AVH were excluded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A Quasi-experimental design There is an intervention group (receiving UDCA + standard care) and a control group (receiving standard care only) standard care is fluids, anti-emetic medicines like Domperidone
| Arm | Type | Receives |
|---|---|---|
| UDCA | Experimental | Drug: Ursodeoxycholic AcidPatients receiving ursodeoxycholic acid in addition to standard care Intervention: |
| Control Group | Active comparator | Other: Supportive CareSupportive management for acute viral hepatitis |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- All patients of either gender
- aged >18 years to 50 years with acute viral hepatitis are included
Key exclusion criteria (5 listed)
- Patients having Hepatitis B, C
- hepatocellular carcinoma
- primary biliary cholangitis
- choldocholithiasis
- patients having normal bilirubin levels with AVH were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ursodeoxycholic AcidAlso: UDCAFor UDCA Arm Ursodeoxycholic acid administered orally at a dose of 10 mg/kg/day in 2 divided doses for 7 days, in addition to standard supportive care, for patients with acute viral hepatitis fulfilling inclusion criteria *standard supportive management including hydration and antiemetics. For Control Arm Patients receive standard supportive care for acute viral hepatitis without administration of ursodeoxycholic acid. | Drug | UDCA |
| Supportive CareStandard supportive treatment including hydration, antiemetics, and monitoring without administration of ursodeoxycholic acid. | Other | Control Group |
Primary outcome
Change in serum total bilirubin levels
Time frame: 7 days
Mean reduction in serum total bilirubin from baseline to Day 7 in patients receiving ursodeoxycholic acid compared to control group
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ursodeoxycholic Acid and Supportive Care in people with Hepatitis A and Hepatitis E Virus Infection, run by Combined Military Hospital, Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum total bilirubin levels (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.