The efficacy of M.G Ointment containing essential oil of Myrtus and comparison of anti-hemorrhoid Ointment in reducing the severity of hemorrhoids and its complications

Comparison of M.G ointment with antihemorrhoid ointment in reducing the severity of hemorrhoids and their complications

This study will be conducted as a randomized clinical trial with a parallel design, double-blind, drug-controlled phase 3 on patients with hemorrhoids grade I and II. Patient sampling will be convenient and after admission, patients will be randomly assigned to three treatment groups of 36 in a block design. In this way, blinding will be three-way. The drug intake in all three groups will be twice a day for two weeks. The study will be conducted as an ITT. Treatment adherence will be assessed by telephone calls to patients.

The study on patients in Kashan will be conducted in a triple-blind manner, with the drugs being filled in the same packaging and tube, and the only difference between the drugs in the three treatment groups being the numerical code created during the randomization phase.

Inclusion criteria: Patients with grade 1 or 2 hemorrhoids Exclusion criteria: Thrombosed external hemorrhoids; strangulated internal hemorrhoids; anal fistula; anal fissure; anal abscess; pregnancy; portal hypertension; grade 3 and 4 hemorrhoids; renal failure; malignant diseases

Intervention group 1: M.G ointment containing 5% Myrtus essential oil manufactured by Barij Essence Pharmaceutical Company Intervention group 2: M.G ointment containing 10% Myrtus essential oil manufactured by Barij Essence Pharmaceutical Company Control group: Antihemorrhoid ointment manufactured by Caspian Pharmaceutical Company

Hemorrhoid severity, bleeding severity, pain during bowel movements

Randomization is performed using the permuted block randomization method, in which all 6 blocks containing three codes A, B, and C are prepared (15 blocks), then random blocks are selected by permutation using a random number table. These blocks form a sequence of codes A, B, and C equal to the sample size, with each code randomly assigned to one of the groups. All randomization steps will be performed in the Clinical Trial Randomization Tool software at https://ctrandomization.cancer.gov.

The medicines are manufactured and prepared in the same packaging, appearance, and size at Barij Essans Pharmaceutical Company. They are then coded based on codes previously prepared using a random number table.

Given that the sponsor of this study is a private company, publication of the data file should take place after the publication of the article.

Given that patient information must remain confidential, any request to receive patient information will be made with the approval of the university's ethics committee.

At least one year after the design is completed and the article is published

All researchers will have access to the data. Only the name and disease details will be kept confidential

Researchers interested in using the data from this study will have access with approval from the university's ethics committee.

Telephone call to the university's vice president for research or the project manager

Submitting the request to the Vice President for Research of the University Referring the request to the Project Manager Letter from the Project Manager to the University Ethics Committee Approval by the University Ethics Committee Sending the required data and information to the applicant