Investigation of the safety of Ursodeoxycholic acid (Cholicray)

Comparing the safety and efficacy of the Ursodeoxycolic acid (Cholicray) and Ursophar in Patients with fatty liver disease and biliary disorders

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210914052480N3

Enrollment

Registered

2023-08-05

Start date

2023-04-09

Completion date

Unknown

Last updated

2023-08-21

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

Conditions

Condition 1: Primary biliary cirrhosis. Condition 2: Fatty (change of) liver, not elsewhere classified(Nonalcoholic fatty liver disease [NAFLD]). Condition 3: Calculus of bile duct. Condition 4: cholangitis. Primary biliary cirrhosis Fatty (change of) liver, not elsewhere classified Calculus of bile duct with cholangitis Cholangitis

Interventions

Intervention 1: Intervention group: The group receiving URSODEOXYCHOLIC ACID CAPSULE ORAL with a standard dose (13to15 milligram per kilogram per day) or CHOLICRAY (Rayhaneh Pharmaceutical Company) fo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: above 18 years old Consent to participate in the study Presence of liver or biliary disorders such as fatty liver, cholangitis, Primary biliary cirrhosis, Calculus of bile duct.

Exclusion criteria

Exclusion criteria: pregnancy

Design outcomes

Primary

Measure	Time frame
Change in sense of taste. Timepoint: Before the intervention and after the intervention. Method of measurement: asking the patient and filling the checklist.;Alanine transaminase(ALT). Timepoint: Before the intervention and after the intervention. Method of measurement: Mindray BS-800 Bio-Chemistry Analyzer.;Skin rashes. Timepoint: Before the intervention and after the intervention. Method of measurement: asking the patient and filling the checklist.;Eye dryness. Timepoint: Before the intervention and after the intervention. Method of measurement: asking the patient and filling the checklist.;Chest pain. Timepoint: Before the intervention and after the intervention. Method of measurement: asking the patient and filling the checklist.;Muscle pain. Timepoint: Before the intervention and after the intervention. Method of measurement: asking the patient and filling the checklist.;Frequent urination. Timepoint: Before the intervention and after the intervention. Method of measurement: asking the patient and filling the checklist.;Total Bilirubin test. Timepoint: Before the intervention and after the intervention. Method of measurement: Mindray BS-800 Bio-Chemistry Analyzer.;Alkaline phosphatase(ALP). Timepoint: Before the intervention and after the intervention. Method of measurement: Mindray BS-800 Bio-Chemistry Analyzer.;Aspartate transaminase(AST). Timepoint: Before the intervention and after the intervention. Method of measurement: Mindray BS-800 Bio-Chemistry Analyzer.;Direct Bilirubin test. Timepoint: Before the intervention and after the intervention. Method of measurement: Mindray BS-800 Bio-Chemistry Analyzer.;Skin itching. Timepoint: Before the intervention and after the intervention. Method of measurement: asking the patient and filling the checklist.;Skin dryness. Timepoint: Before the intervention and after the intervention. Method of measurement: asking the patient and filling the checklist.;Skin redness and hives. Timepoint: Before the intervention and aft	—

Measure

Time frame

Change in sense of taste. Timepoint: Before the intervention and after the intervention. Method of measurement: asking the patient and filling the checklist.;Alanine transaminase(ALT). Timepoint: Before the intervention and after the intervention. Method of measurement: Mindray BS-800 Bio-Chemistry Analyzer.;Skin rashes. Timepoint: Before the intervention and after the intervention. Method of measurement: asking the patient and filling the checklist.;Eye dryness. Timepoint: Before the intervention and after the intervention. Method of measurement: asking the patient and filling the checklist.;Chest pain. Timepoint: Before the intervention and after the intervention. Method of measurement: asking the patient and filling the checklist.;Muscle pain. Timepoint: Before the intervention and after the intervention. Method of measurement: asking the patient and filling the checklist.;Frequent urination. Timepoint: Before the intervention and after the intervention. Method of measurement: asking the patient and filling the checklist.;Total Bilirubin test. Timepoint: Before the intervention and after the intervention. Method of measurement: Mindray BS-800 Bio-Chemistry Analyzer.;Alkaline phosphatase(ALP). Timepoint: Before the intervention and after the intervention. Method of measurement: Mindray BS-800 Bio-Chemistry Analyzer.;Aspartate transaminase(AST). Timepoint: Before the intervention and after the intervention. Method of measurement: Mindray BS-800 Bio-Chemistry Analyzer.;Direct Bilirubin test. Timepoint: Before the intervention and after the intervention. Method of measurement: Mindray BS-800 Bio-Chemistry Analyzer.;Skin itching. Timepoint: Before the intervention and after the intervention. Method of measurement: asking the patient and filling the checklist.;Skin dryness. Timepoint: Before the intervention and after the intervention. Method of measurement: asking the patient and filling the checklist.;Skin redness and hives. Timepoint: Before the intervention and aft

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Heiat

Bagheiat-allah University of Medical Sciences

mohamad.heiat@gmail.com+98 21 8755 5250

Outcome results

None listed

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