]>
IRCT20220417054557N2 IRCT 2024-03-06 Shahid Beheshti University of Medical Sciences The effect of inositol on the improvement of primary sclerosing cholangitis patients Investigation the effect of Inositol in patients with Primary Sclerosing Cholangitis 2024-03-10 anticipated 40 Complete https://irct.ir/trial/75812 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are assigned to two groups using the random block method. The number of blocks will be 22 and in each block two, four, or six patients according to the order of entry are studied. Random allocation of blocks of patients to two groups receiving Inositol and receiving placebo It will be done through Sealed Envelope online software. Concerning the site https://www.sealedenvelope.com/simple-randomiser/v1/lists By specifying the total number of samples, and the number of possible samples in each random block (2, 4 and 6 patients), randomization is performed by online software. For example, like the following output: block identifier block size sequence within block treatment 1 2 1 Group B 1 2 2 Group A 2 4 1 Group A 2 4 2 Group B 2 4 3 Group B 2 4 4 Group A 3 2 1 Group A 3 2 2 Group B ... which is the block number, the number of patients in the block, and the random assignment of each patient (with the corresponding number) to the treatment group. The randomized list of blocks will be placed in sealed envelopes and will be provided to the gastroenterologist on a daily basis, Blinding description: Participants do not know whether they are receiving inositol or placebo. Also, to prevent exploitation, the researcher investigating the results is unaware of the allocation of the groups. 3 Primary Sclerosing Cholangitis. Intervention 1: Intervention group: Recipient of inositol supplement 800 mg/day for three months. Intervention 2: Intervention group: placebo. No - There is not a plan to make this available Justification or reason for not sharing IPD is Confidentiality and privacy
public Elham Mortazavi
Arabi street, Velenjak
Tehran Iran (Islamic Republic of) 1985717443 +98 21 23871 mortazavielham@yahoo.com Shahid Beheshti University of Medical Sciences scientific Shabnam Shahrokh
Arabi street, Velenjak
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2243 2525 shabnamshahrokh@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) cholestatic liver disease for at least 6 months serum alkaline phosphatase levels 1.5 times the normal upper limit 18 years 75 years Both co-existing liver diseases such as alcoholic liver disease and NAFLD, autoimmune hepatitis, chronic B or C hepatitis, PBC, hemochromatosis, Wilson's disease, congenital biliary disease, and cholangiocarcinoma K83.1 Obstruction of bile duct Treatment - Drugs Treatment - Drugs Intervention group: Recipient of inositol supplement 800 mg/day for three months Intervention group: placebo Alanine transaminase. Timepoint: before intervention and 3 month later. Method of measurement: blood test. Aspartate aminotransferase. Timepoint: before intervention and 3 month later. Method of measurement: blood test. Albumin. Timepoint: before intervention and 3 month later. Method of measurement: blood test. Bilirubin. Timepoint: before intervention and 3 month later. Method of measurement: blood test. Alkaline Phosphatase. Timepoint: before intervention and 3 month later. Method of measurement: blood test. Alleviation of prutrius. Timepoint: before intervention and 3 month later. Method of measurement: physical examination. A decline in the Mayo Risk Score of patients. Timepoint: before intervention and 3 months later. Method of measurement: Mayo Risk scale measurement. Shahid Beheshti University of Medical Sciences Approved 2024-02-07 Ethics Committee in Biomedical Research, Gastroenterology and Liver Research Institute, Shahid Behes Arabi street, Velenjak Tehran Tehran Iran (Islamic Republic of)