MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)Phase 2NCT07902219
Qurse Revand for MASLD: A Randomized Controlled Safety and Efficacy Trial
A Phase 2 study testing Qurse Revand in people with MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), run by National Institute of Unani Medicine, Bengaluru at 1 site in India.
Trial summary
This study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety, efficacy of the Unani compound formulation Qurse Revand compared to a placebo in adult participants with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
- What is being tested?
- Qurse Revand
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteIndia
- Study dates
- 1 May 2027to 1 May 2029
- Phase
- Phase 2
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed Cases of Fatty Liver (Grade Ⅰ \&Ⅱ) by USG.
- Participants with Presence of at least 1or more cardiometabolic risk factor
- Excess adiposity (BMI of ≥25 kg/m², Waist circumference of ≥94 cm in men and ≥80 cm in women)
- Disorders of glucose metabolism (Prediabetes- HbA1c (5.7% to 6.4 %), FPG- 100 to 125 mg/dL, Type 2 diabetes mellitus- HbA1c of ≥6.5%; FPG of ≥126 mg/dL)
- Hypertriglyceridemia (Plasma triglycerides ≥150 mg/dL)
- High-density lipoprotein (HDL) cholesterol: <40 mg/dL in men or ≤50 mg/dL in women
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- Arterial hypertension: Resting blood pressure of 130/85 mm Hg or greater or ongoing antihypertensive treatment
- Participants with minimal or no alcohol intake (i.e. <20 g/day for females and <30 g/day for males).
- Participants of any gender, aged between 20-60yrs.
Who cannot join
- Pregnant And Lactating Mother
- Fatty Liver Grade Ⅲ (by USG)
- Known History of Hepatitis, Liver Cancer, systemic disorders like Malignancies, cardiovascular diseases.
- Participants on medications causing steatosis (Amiodarone, Valproic Acid, Methotrexate, Tamoxifen, Glucocorticoids)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site
National Institute of Unani Medicine Bangalore
Bangalore, Karnataka, 560091
Dr.Shabnam Kudchi, PhD, +918296573334, shabnamkudchi5@gmail.com
About this study
Official title: Evaluation of Safety and Efficacy of Qurse Revand in Metabolic Dysfunction-Associated Steatotic Liver Disease: A Randomized Double-Blind Placebo-Controlled Clinical Trial
This study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety, efficacy of the Unani compound formulation Qurse Revand compared to a placebo in adult participants with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD).
Read the detailed description
This randomized, double-blind, placebo-controlled clinical trial evaluates the safety, efficacy, and quality-of-life impact of the Unani formulation Qurse Revand in 128 adults (aged 20-60) with Grade I or II Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). Participants take either Qurse Revand (3 tablets of 835 mg) or a matching wheat flour placebo twice daily before meals for 60 days alongside a Mediterranean diet and 30 minutes of daily brisk walking 5 days per week. Throughout the trial, participants visit the clinic every 15 days-at Baseline (Day 0) and Follow-ups on Days 15, 30, 45, and 60-to undergo physical examinations, abdominal ultrasonography, liver and kidney function tests, lipid profiles, hematological evaluations, symptom tracking, and quality-of-life assessments (EQ-5D).
- Being tested
- Qurse Revand, Placebo
- Keywords
- MASLD (Metabolic dysfunction-Associated Steatotic Liver Disease), NAFLD(Non-Alcoholic Fatty Liver Disease)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qurse RevandDrug
Qurse Revand (3 tablets of 835 mg each) twice daily before meals for 60 days
PlaceboDrug
placebo (wheat flour) (3 tablets of 835 mg each) twice daily before meals for 60 days,
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Placebo (Wheat flour) Receives: Drug: Placebo |
| Test | Experimental | Qurse Revand Receives: Drug: Qurse Revand |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fatty Liver Grading by USG
Changes /decrease in fatty liver grading(from grade 1,2 to grade 0,1)by USG
Measured: From enrollment to the end of treatment at 60 Days
Secondary outcomes (3)
Change in Fatty Liver Index (FLI)
Change/Decrease in fatty liver Index. FLI calculates a score ranging from 0 to 100 using four routinely measured parameters.
FLI Score Interpretation:
(FLI < 30 = Low Probability, 30 ≤ FLI < 60 =Intermediate / Indeterminate, FLI ≥ 60= High Probability )
Measured: From enrollment to the end of treatment at 60 days
Change in Lipid Profile
Change in serum Triglycerides levels(mg/dL or mmol/L) \&Change in serum High-Density Lipoprotein (HDL) Cholesterol(mg/dL or mmol/L)
Measured: From enrollment to the end of treatment at 60 days
Changes in Health-related quality of life using EuroQol-5D (EQ-5D)
The EQ-5D consists of two main components:
- EQ-5D Index Score (Utility Score): How it is calculated: The combinations from the 5 dimensions are converted into a single summary index using population-specific country value sets. Scale Range: Typically spans from 1.0 (Full/Perfect Health) to 0.0 (A state equivalent to death). Negative values are possible for health states valued as worse than death.
- EQ Visual Analogue Scale (EQ-VAS): A 0-100 rating scale measuring overall perceived health (100 = best,0 = worst).
Measured: From enrollment to the end of treatment at 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start1 May 2027 (estimated)
- Primary completion1 May 2029 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)Studies 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
- All enrolled participants will be randomly assigned to either the test or control group in a 1:1ratio using computer-generated random sequences
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Unani Medicine, Bengaluru
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shabnam Kudchi, National Institute of Unani Medicine, Bengaluru
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07902219
- Sponsor's protocol ID
- NIUM/IEC/2025-26/048PhD/Moal03
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Efficacy of Qurse Revand in Metabolic Dysfunction-Associated Steatotic Liver Disease: A Randomized Double-Blind Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07902219
- Acronym / sponsor ID
- NIUM/IEC/2025-26/048PhD/Moal03
- Keywords
- MASLD (Metabolic dysfunction-Associated Steatotic Liver Disease), NAFLD(Non-Alcoholic Fatty Liver Disease)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- National Institute of Unani Medicine, BengaluruUniversity, hospital or other
- Study start
- 1 May 2027 (estimated)
- Primary completion
- 1 May 2029 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 28 Oct 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.
This study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety, efficacy of the Unani compound formulation Qurse Revand compared to a placebo in adult participants with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD).
Detailed description
This randomized, double-blind, placebo-controlled clinical trial evaluates the safety, efficacy, and quality-of-life impact of the Unani formulation Qurse Revand in 128 adults (aged 20-60) with Grade I or II Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). Participants take either Qurse Revand (3 tablets of 835 mg) or a matching wheat flour placebo twice daily before meals for 60 days alongside a Mediterranean diet and 30 minutes of daily brisk walking 5 days per week. Throughout the trial, participants visit the clinic every 15 days-at Baseline (Day 0) and Follow-ups on Days 15, 30, 45, and 60-to undergo physical examinations, abdominal ultrasonography, liver and kidney function tests, lipid profiles, hematological evaluations, symptom tracking, and quality-of-life assessments (EQ-5D).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- All enrolled participants will be randomly assigned to either the test or control group in a 1:1ratio using computer-generated random sequences
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: PlaceboPlacebo (Wheat flour) |
| Test | Experimental | Drug: Qurse RevandQurse Revand |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Diagnosed Cases of Fatty Liver (Grade Ⅰ \&Ⅱ) by USG.
- Participants with Presence of at least 1or more cardiometabolic risk factor
- Participants with minimal or no alcohol intake (i.e. <20 g/day for females and <30 g/day for males).
- Participants of any gender, aged between 20-60yrs.
Key exclusion criteria (4 listed)
- Pregnant And Lactating Mother
- Fatty Liver Grade Ⅲ (by USG)
- Known History of Hepatitis, Liver Cancer, systemic disorders like Malignancies, cardiovascular diseases.
- Participants on medications causing steatosis (Amiodarone, Valproic Acid, Methotrexate, Tamoxifen, Glucocorticoids)
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 |
|---|---|---|
| Qurse RevandQurse Revand (3 tablets of 835 mg each) twice daily before meals for 60 days | Drug | Test |
| Placeboplacebo (wheat flour) (3 tablets of 835 mg each) twice daily before meals for 60 days, | Drug | Control |
Primary outcome
Change in Fatty Liver Grading by USG
Time frame: From enrollment to the end of treatment at 60 Days
Changes /decrease in fatty liver grading(from grade 1,2 to grade 0,1)by USG
3 secondary outcomes
Change in Fatty Liver Index (FLI)
Time frame: From enrollment to the end of treatment at 60 days
Change in Lipid Profile
Time frame: From enrollment to the end of treatment at 60 days
Changes in Health-related quality of life using EuroQol-5D (EQ-5D)
Time frame: From enrollment to the end of treatment at 60 days
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 28 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 Qurse Revand in people with MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), run by National Institute of Unani Medicine, Bengaluru at 1 site in India.
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 9 inclusion and 4 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 28 Oct 2026. 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 India. 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?
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?
Contact Dr. Shabnam Kudchi, PhD (+918296573334, shabnamkudchi5@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fatty Liver Grading by USG (time frame: From enrollment to the end of treatment at 60 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 28 Oct 2026.