Investigation the effect of Inositol in patients with Primary Sclerosing Cholangitis

Investigation the effect of inositol on Primary Sclerosing Cholangitis patients

Clinical trial with parallel groups, double-blind, randomized, phase 3 on 100 patients. Patients will be divided into two groups in random blocks.

In this double blinded study, patients included in the study will be taking a disease history and performing a physical examination, blood samples will be collected and sent for laboratory evaluation, measuring AST, ALT,ALKP, Albumin and Bilirubin (total and direct). Then patients were randomly assigned in a 1:1 ratio to receive either a placebo or inositol supplement (800 mg) in identical form and packaging, which will be taken for 3 months. after that the patients will be reevaluated.

Inclusion criteria: cholestatic liver disease for at least 6 months, serum alkaline phosphatase level 1.5 times the upper limit of normal, and evidence of multifocal dilatation and stenosis of intrahepatic bile ducts, extrahepatic bile ducts. Exclusion criteria: cancer, cardiopulmonary disease; Anticipated liver transplant; cirrhosis, portal hypertension; pregnancy and nursing mothers; concomitant liver diseases, gallstones, recurrent ascending cholangitis, sensitivity to inositol or a history of severe side effects; Kidney failure

The first group received 800 mg inositol supplement. The second group received placebo

normal level of AST, ALT, Albumin and Bilirubin and also 50% reduction in ALKP, alleviation of and prutrius, a decline in the Mayo Risk Score of patients.

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.

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.

Confidentiality and privacy

Study protocol, statistical analysis map, study design, clinical study report will be made available

After the publication of the article

Researchers, medical students, professors

If used for future research and in compliance with the principles of referencing

Corresponding Author Dr. Shabnam Shahrokh shabnamshahrokh@gmail.com

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