Effect of a traditional preparation rectal suppository from Commiphora mukul (Hook. Ex Stocks) Engl. And Allium porrum L. on hemorrhoids in comparison with conventional anti-hemorrhoid suppository: A double-blind controlled trial

The aim of this study is to evaluate the therapeutic effect of a traditional rectal suppository containing Commiphora mukul (Hook. Ex Stocks) Engl. and Allium porrum L. in hemorrhoid.

A clinical trial with an interventional and a control groups, double-blind, 80 patients, randomization by block randomization method.

In this study, patients were recruited at Shahid Rahnamon Hospital in Yazd. The doctor and patients are blinded in the study. The researcher provides the traditional rectal suppository and conventional anti-hemorrhoid suppository to the patient in sealed envelopes with a allocation concealment method, and the color and packaging of the both groups are completely similar.

Patients who suffer from hemorrhoids and dose not require emergency surgery with approval of a surgeon specialist are included in the study. The main exclusion criteria are other anorectal diseases (ex. fistula or anal cancer and perianal fissure), pregnancy and lactation.

The patients are divided into two groups of 40 people randomly by block randomization method. The Colo-Rectal Evaluation of Clinical Therapeutics Scale (CORECTS) questionnaire and consent form completed by every patients. the Interventional group is taking a Traditional Rectal suppository and the control group Anti-hemorrhoid suppository. The medication in all two groups is taking a rectal suppository for two weeks, twice a day. After the end of the consumption period, the patient's symptoms are evaluated by the questionnaire.

Pain, itching, bleeding and swelling relief are evaluated according to the CORECTS questionnaire.

The patients are divided into two groups of 40 people randomly by simple block randomization method. All subjects are made aware of the content of the study and written informed consent was obtained from each patient. Coding and sealing of both suppositories by a non-researcher of the study is done by simple block randomization method and using Random Number Generation software. During that time the doctor, researcher and patients are not aware of the block numbers. Common anti-hemorrhoid suppositories are removed from the relevant company's packaging and placed in specially designed boxes for clinical trials, and the labels are removed. The Colo-Rectal Evaluation of Clinical Therapeutics Scale questionnaire (CORECTS) questionnaire completed by individuals. The Interventional group is taking a Traditional Rectal suppository and the control group Anti-hemorrhoid suppository. Both groups of people receive the Drugs in the form of sealed envelopes with a allocation concealment method, and it should be noted that the color and packaging of the both groups drugs are completely similar. The medication in all two groups is taking a rectal suppository for two weeks, twice a day. After the end of the consumption period, the patient's symptoms are evaluated by the questionnaire. The data are collected after 14 days, and then the codes of the drug packages and related questionnaires are opened.

The doctor and the patient are blinded in the study. The researcher provides the traditional rectal suppository and conventional anti-hemorrhoid suppository to the patient in sealed envelopes with a allocation concealment method, and the color and packaging of the both groups are completely similar.

Only a part of data like primary outcome can be shared.

The access period starts 1 year after the publication time of results

This data will be available only to researchers working in academic and scientific institutions.

The data will be made available to researchers for further studies or more advanced analysis.

Researchers can send an email regarding the request for the data of our study to Dr. Abdolali Mohagheghzadeh. Email: mohaghegh@sums.ac.ir

The researchers can request for this study's data through an e-mail one year after the publication data of this study in one of the pee-reviewed journals.