NASHPhase 2NCT05804305
Misoprostol for NASH
A Phase 2 study testing Misoprostol in people with NASH, run by Ziauddin University at 1 site in Pakistan.
Trial summary
The aim of this randomised control trial is to evaluate the effect of Misoprostol in treating patients with NASH. Read more about this study
- Who is it for?
- Ages 25 to 64 years
- Conditions the study is for
- NASH
- What is being tested?
- Misoprostol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2022to 31 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 25 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients between age 25 and 64 years
- Patients having NAFLD as evident by a radiologic test like ultrasound/fibroscan/CT scan etc.
- ALT level of 1.5 times ULN
- If already known case of NAFLD, then patient should be on stable doses of Vitamin E, oral hypoglycemics or anti-lipidemic drugs, with no change in medication during 6 months prior to recruitment.
Who cannot join
- Patients with age less than 18 yrs or more than 80 yrs,
- Women of childbearing age
- Clinically significant acute or chronic liver disease unrelated to NAFLD
- Evidence of hepatitis B and C
- Evidence of primary biliary cirrhosis, primary sclerosing cholangitis, or biliary obstruction
- Autoimmune hepatitis
Show all 15Show fewer
- Drug-induced steatohepatitis (ingestion of drugs known to produce hepatic steatosis including corticosteroids, high-dose estrogens, methotrexate, tetracycline or amiodarone in the previous 6 months)
- Any cardiovascular event or evidence of active CVS disease
- Type 1 Diabetes
- Those consuming alcohol of over 20 grams/day for males and 10 grams/day for females
- Severe end-organ damage
- Human immunodeficiency virus (HIV) infection
- Compensated and decompensated cirrhosis
- Patients with uncontrolled diabetes
- Mental instability or incompetence
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Misoprostol for Non-alcoholic Steatohepatitis- a Randomized Control Trial
The aim of this randomised control trial is to evaluate the effect of Misoprostol in treating patients with NASH.
- Conditions
- NASH
- Being tested
- Misoprostol, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Misoprostol is a prostaglandin E1 analogue
PlaceboDrug
Placebo contained substance that has no therapeutic value.
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol | Active comparator | 600 mcg of Misoprostol per day in three divided doses was given to the patients in the treatment group for a period of two months Receives: Drug: Misoprostol |
| Placebo | Placebo comparator | Placebo was given to the patients three times daily for a duration of two months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in liver function tests
The change in serum alanine aminotransferase (ALT) measured in international units per liter (IU/L), aspartate aminotransferase (AST) in IU/L, gamma-glutamyl transferase (GGT) in IU/L, alkaline phosphatase (ALP) in IU/L, total bilirubin in milligrams per decilitre (mg/dl), direct bilirubin in mg/dl and indirect bilirubin in mg/dl from baseline was ascertained by performing paired sample t-test.
Measured: Baseline to 2 Months
Change From Baseline in Interleukin-6 (IL-6)
The change in Interleukin-6 measured in picograms per milliliter (pg/ml) from baseline was ascertained by performing paired sample t-test.
Measured: Baseline to 2 Months
Change From Baseline in endotoxin levels
The change in endotoxin levels measured in endotoxin units per milliliter (EU/mL) from baseline was ascertained by performing paired sample t-test.
Measured: Baseline to 2 Months
Secondary outcomes (5)
Change From Baseline in hepatic steatosis
The change in hepatic fibrosis from baseline, measured in kilopascals (kPa) by doing fibroscan, was ascertained by performing paired sample t-test.
Measured: Baseline to 2 Months
Change From Baseline in hepatic fibrosis
The change in hepatic fibrosis from baseline, measured through the controlled attenuation parameter (CAP) by doing fibroscan, was ascertained by performing paired sample t-test.
Measured: Baseline to 2 Months
Change From Baseline in dyslipidemia
The change in serum cholesterol level measured in mg/dl, triglycerides in mg/dl, HDL (high-density lipoprotein) cholesterol in mg/dl, LDL (low-density lipoprotein) cholesterol in mg/dl, VLDL (very low-density lipoprotein) cholesterol in mg/dl, non-HDL cholesterol in mg/dl, from baseline by doing fasting lipid profile and performing paired sample t-test.
Measured: Baseline to 2 Months
Change From Baseline in Insulin resistance
The change in Insulin resistance as ascertained by measuring fasting insulin in millionths of an International Unit per milliliter(uU/mL), and fasting blood sugar in mg/dl and then calculating homeostasis model assessment-estimated insulin resistance (HOMA-IR).
HOMA IR calculation formula:
HOMA IR = fasting insulin (uU/mL) x fasting glucose (mg/dl)/405
Measured: Baseline to 2 Months
Incidence of Adverse Events
Safety and tolerability were measured by providing adverse event form to the study participants. Any adverse event experienced by the study participants was mentioned in the adverse event form and notified to the primary investigator through a phone call.
Measured: Baseline to 2 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start1 Jul 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NASHStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a double blind randomised control trial to see the effect of Misoprostol in treating patients with NASH
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziauddin University
- Sponsor type
- University, hospital or other
- Collaborators
- Nabiqasim Industries (Pvt) Ltd
- Responsible party
- Principal investigator, DR MEHREEN SIYAL, Ziauddin University
- Investigators
- Mehreen Siyal, MBBS, FCPS-1, Principal investigator, Dr. Ziauddin Hospital Clifton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05804305
- Sponsor's protocol ID
- 3280221MSGE
- Status last verified
- Mar 2023
- First submitted
- 20 Jan 2023
- Last updated
- 7 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Siyal M, Abbas Z, Qadeer MA, Saeed A, Ali U, Khatoon A. Misoprostol for non-alcoholic steatohepatitis: a randomised control trial. BMJ Open Gastroenterol. 2024 Jun 6;11(1):e001342. doi: 10.1136/bmjgast-2023-001342.
PubMed 38844374
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Misoprostol for Non-alcoholic Steatohepatitis- a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05804305
- Acronym / sponsor ID
- 3280221MSGE
- Conditions
- NASH
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ziauddin UniversityUniversity, hospital or other
- Collaborators
- Nabiqasim Industries (Pvt) Ltd
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 7 Apr 2023 (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.
The aim of this randomised control trial is to evaluate the effect of Misoprostol in treating patients with NASH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a double blind randomised control trial to see the effect of Misoprostol in treating patients with NASH
| Arm | Type | Receives |
|---|---|---|
| Misoprostol | Active comparator | Drug: Misoprostol600 mcg of Misoprostol per day in three divided doses was given to the patients in the treatment group for a period of two months |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo was given to the patients three times daily for a duration of two months |
Who may qualify
- Ages
- 25 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients between age 25 and 64 years
- Patients having NAFLD as evident by a radiologic test like ultrasound/fibroscan/CT scan etc.
- ALT level of 1.5 times ULN
- If already known case of NAFLD, then patient should be on stable doses of Vitamin E, oral hypoglycemics or anti-lipidemic drugs, with no change in medication during 6 months prior to recruitment.
Key exclusion criteria (15 listed)
- Patients with age less than 18 yrs or more than 80 yrs,
- Women of childbearing age
- Clinically significant acute or chronic liver disease unrelated to NAFLD
- Evidence of hepatitis B and C
- Evidence of primary biliary cirrhosis, primary sclerosing cholangitis, or biliary obstruction
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 |
|---|---|---|
| MisoprostolMisoprostol is a prostaglandin E1 analogue | Drug | Misoprostol |
| PlaceboPlacebo contained substance that has no therapeutic value. | Drug | Placebo |
Primary outcome
Change From Baseline in liver function tests
Time frame: Baseline to 2 Months
The change in serum alanine aminotransferase (ALT) measured in international units per liter (IU/L), aspartate aminotransferase (AST) in IU/L, gamma-glutamyl transferase (GGT) in IU/L, alkaline phosphatase (ALP) in IU/L, total bilirubin in milligrams per decilitre (mg/dl), direct bilirubin in mg/dl and indirect bilirubin in mg/dl from baseline was ascertained by performing paired sample t-test.
Change From Baseline in Interleukin-6 (IL-6)
Time frame: Baseline to 2 Months
The change in Interleukin-6 measured in picograms per milliliter (pg/ml) from baseline was ascertained by performing paired sample t-test.
Change From Baseline in endotoxin levels
Time frame: Baseline to 2 Months
The change in endotoxin levels measured in endotoxin units per milliliter (EU/mL) from baseline was ascertained by performing paired sample t-test.
5 secondary outcomes
Change From Baseline in hepatic steatosis
Time frame: Baseline to 2 Months
Change From Baseline in hepatic fibrosis
Time frame: Baseline to 2 Months
Change From Baseline in dyslipidemia
Time frame: Baseline to 2 Months
Change From Baseline in Insulin resistance
Time frame: Baseline to 2 Months
Incidence of Adverse Events
Time frame: Baseline to 2 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Derived from this study: PubMed 38844374Siyal M, Abbas Z, Qadeer MA, Saeed A, Ali U, Khatoon A. Misoprostol for non-alcoholic steatohepatitis: a randomised control trial. BMJ Open Gastroenterol. 2024 Jun 6;11(1):e001342. doi: 10.1136/bmjgast-2023-001342.
Related trials for NASH
RecruitingPhase 2
Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Recruiting
Exercise for an Aging Liver (EXALIVER)
MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, MASH - Metabolic Dysfunction-Associated Steatohepatitis
Recruiting
iWAIST Trial: ERCG (Endoscopic Radial Compression Gastroplasty) +Optimized Lifestyle Intervention (OLI) vs Sham + OLI for Weight Loss
Overweight and/or Obesity, Metabolic Syndrome
RecruitingObservational study
Evaluation of Non-Invasive Tests for Metabolic Liver Disease
Metabolic Associated Fatty Liver Disease, Metabolic Associated Steatotic Liver Disease
Active, not recruitingPhase 1/2
A Trial to Learn How Safe AZD9550 Monotherapy and Combined With AZD6234 is in People With or Without Type 2 Diabetes Who Are Living With Obesity and Overweight
Overweight and Obesity
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. This study is not recruiting at the moment.
Mehreen Siyal, MBBS, FCPS-1 principal investigator
Dr. Ziauddin Hospital Clifton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Misoprostol in people with NASH, run by Ziauddin University at 1 site in 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 4 inclusion and 15 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: finished, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 From Baseline in liver function tests (time frame: Baseline to 2 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05804305, which also lists 1 linked publication.
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 7 Apr 2023.