Evaluating the Effect of Curcumin on Patients with Recurrent Primary Sclerosing Cholangitis after Liver Transplantation

Evaluation of the Efficacy and Safety of Curcumin on Clinical Symptoms, Quality of Life, and Laboratory Parameters in Patients with Recurrent Primary Sclerosing Cholangitis (PSC) after Liver Transplantation: A Double-Blind Randomized Clinical Trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20120731010453N7

Enrollment

Registered

2025-05-29

Start date

2025-07-06

Completion date

Unknown

Last updated

2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

recurrent Primary Sclerosing Cholangitis. Diseases of liver

Interventions

Intervention group: Administration of one 25 mL oral vial of Lanzoun® daily, with each vial containing 60mg of curcumin.

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Adult patients (=18 years) with first liver transplantation and confirmed diagnosis of recurrent primary sclerosing cholangitis (PSC) No known hypersensitivity to curcumin

Exclusion criteria

Exclusion criteria: Patients with repeated liver transplantation (non-primary transplant) Patients with a history of curcumin hypersensitivity

Design outcomes

Primary

Measure	Time frame
Evaluation of curcumin's effect on biochemical markers associated with PSC: alkaline phosphatase, bilirubin, and liver enzymes. Timepoint: Laboratory and clinical assessments will be conducted at three time points: baseline (Day 0), midpoint (Week 6), and study completion (Week 12). Method of measurement: Serum levels of ALP, bilirubin, and liver enzymes (AST/ALT) measured by spectrophotometry after 8-hour fasting.	—

Measure

Time frame

Evaluation of curcumin's effect on biochemical markers associated with PSC: alkaline phosphatase, bilirubin, and liver enzymes. Timepoint: Laboratory and clinical assessments will be conducted at three time points: baseline (Day 0), midpoint (Week 6), and study completion (Week 12). Method of measurement: Serum levels of ALP, bilirubin, and liver enzymes (AST/ALT) measured by spectrophotometry after 8-hour fasting.

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Secondary

Measure	Time frame
Evaluation of curcumin's efficacy in reducing PSC clinical symptoms, particularly fatigue and pruritus. Timepoint: Measurements will be taken at three time points: baseline (Day 0), interim (Week 6), and study end (Week 12). Method of measurement: Clinical symptoms (fatigue and pruritus) are assessed using standardized questionnaires and rating scales. Pruritus: VAS scale (10 cm line) Fatigue: FACIT-Fatigue questionnaire Quality of life: CLDQ and SF-36 questionnaires.	—

Measure

Time frame

Evaluation of curcumin's efficacy in reducing PSC clinical symptoms, particularly fatigue and pruritus. Timepoint: Measurements will be taken at three time points: baseline (Day 0), interim (Week 6), and study end (Week 12). Method of measurement: Clinical symptoms (fatigue and pruritus) are assessed using standardized questionnaires and rating scales. Pruritus: VAS scale (10 cm line) Fatigue: FACIT-Fatigue questionnaire Quality of life: CLDQ and SF-36 questionnaires.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMojtaba Shafiekhani

Shiraz University of Medical Sciences

mojtabashafiekhani@gmail.com+98 71 3242 4255

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026