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Not yet recruitingNCT07902219Updated Oct 28, 2026

Qurse Revand for MASLD: A Randomized Controlled Safety and Efficacy Trial

A Phase 2 interventional study of Qurse Revand and Placebo in MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), sponsored by National Institute of Unani Medicine, Bengaluru. Not yet recruiting at 1 site in India. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-28.

Sponsored by National Institute of Unani Medicine, Bengaluru · Phase 2, Interventional, and Treatment

Updated Oct 28, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
128
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study 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 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).

02

Conditions studied

  • MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)

Keywords

  • MASLD (Metabolic dysfunction-Associated Steatotic Liver Disease)
  • NAFLD(Non-Alcoholic Fatty Liver Disease)
03

In context

Lead sponsor

National Institute of Unani Medicine, Bengaluru is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosed Cases of Fatty Liver (Grade Ⅰ \&Ⅱ) by USG.
  • Participants with Presence of at least 1or more cardiometabolic risk factor

    1. Excess adiposity ( of ≥25 kg/m², Waist circumference of ≥94 cm in men and ≥80 cm in women)
    2. Disorders of glucose metabolism (Prediabetes- (5.7% to 6.4 %), FPG- 100 to 125 mg/dL, Type 2 diabetes mellitus- HbA1c of ≥6.5%; FPG of ≥126 mg/dL)
    3. Hypertriglyceridemia (Plasma triglycerides ≥150 mg/dL)
    4. High-density lipoprotein (HDL) cholesterol: \<40 mg/dL in men or ≤50 mg/dL in women
    5. 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.

Exclusion criteria

Exclusion criteria:

  • Pregnant And Lactating Mother
  • Fatty Liver Grade Ⅲ (by USG)
  • Known History of Hepatitis, Liver Cancer, systemic disorders like , cardiovascular diseases.
  • Participants on medications causing steatosis (Amiodarone, Valproic Acid, Methotrexate, Tamoxifen, )
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
128 participants (estimated)

Study arms

  • Placebo comparator
    Control

    Placebo (Wheat flour)

    Drug: Placebo

  • Experimental
    Test

    Qurse Revand

    Drug: Qurse Revand

Interventions

  • DrugQurse Revand

    Qurse Revand (3 tablets of 835 mg each) twice daily before meals for 60 days

  • DrugPlacebo

    placebo (wheat flour) (3 tablets of 835 mg each) twice daily before meals for 60 days,

06

What researchers measure

Primary outcomes

  1. Change in Fatty Liver Grading by USG

    Changes /decrease in fatty liver grading(from grade 1,2 to grade 0,1)by USG

    Time frame: From enrollment to the end of treatment at 60 Days

Secondary outcomes

  1. 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 )

    Time frame: From enrollment to the end of treatment at 60 days

  2. 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)

    Time frame: From enrollment to the end of treatment at 60 days

  3. Changes in Health-related quality of life using EuroQol-5D (EQ-5D)

    The EQ-5D consists of two main components: 1. 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. 2. EQ Visual Analogue Scale (EQ-VAS): A 0-100 rating scale measuring overall perceived health (100 = best,0 = worst).

    Time frame: From enrollment to the end of treatment at 60 days

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for May 2027; primary completion for May 2029, 24 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 8, 2026
First posted
Oct 28, 2026
StartEst.
May 1, 2027
Primary completionEst.
May 1, 2029
CompletionEst.
May 1, 2029
Last update
Oct 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 28, 2026
Show all 1 update
  1. Oct 28, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07902219
Lead sponsor
National Institute of Unani Medicine, Bengaluru
Responsible party
Shabnam Kudchi (PhD Scholar, National Institute of Unani Medicine, Bengaluru) — Principal investigator
First posted
Oct 28, 2026
Start date
May 1, 2027 (estimated)
Primary completion
May 1, 2029 (estimated)
Completion
May 1, 2029 (estimated)
Last update
Oct 28, 2026

Study contacts

Dr. Shabnam Kudchi, PhD
Contact
shabnamkudchi5@gmail.com
+918296573334

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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