The effects of arginine supplementation on clinical symptoms, quality of life and anal internal sphincter pressure in patients with chronic anal fissure

Determination of the effect of arginine supplementation on clinical signs, quality of life and internal anal sphincter pressure in patients with chronic anal fissure

a randomized, double-blind, placebo-control clinical trial with two arms parallel study design

The study will be conducted in the first and second semester of 1398 for adults with chronic anal fissures referred to the gastroenterology clinic of Rasoul-e-Akram Hospital. Eligible individuals after filling written informed consent are randomly divided into two groups that received arginine or placebo. Patients and researchers will be blinded to the interventions. Demographic data, the severity of clinical symptoms, quality of life, stress and anxiety, manometry, physical activity, diet, and anthropometric indexes were evaluated at the beginning and the end of the study.

1. Age between 18 to 65 years 2. BMI between 18.5 to 35 3. Chronic anal fissure 4. Fischer in the posterior and anterior regions of the anus. 5. Non-pregnant and lactating women 6. Non-specific digestive disease, such as Crohn's disease, ulcerative colitis, gastrointestinal cancers and etc. 7. without any diseases that fissure can be their complication: tuberculosis, AIDS, syphilis, herpes, leukemia and etc. 8. No history of malignancy or malignancy in present 9. No history of heart disease 10. No history of fissure and hemorrhoid surgery

Patients with chronic anal fissure will divide into two groups that receive the arginine and the placebo. 90 supplements will be taken by patients 3 times a day for 1 month.

Clinical symptoms Quality of Life Reduce internal anal sphincter pressure

For randomization, the permuted block randomization will be used with quadrilateral blocks. According to the sample size of 76 that has been set, 19 blocks will be produced by using the online site "www.sealedenvelope.com". In order to apply the concealment in the randomization process, unique codes will be used on supplement boxes, the code being generated by the software. By entering each individual into a study based on the generated sequence, the supplement package with the specific code will be allocated to the individual, and therefore, before the person is selected, nobody aware of the type of treatment he will receive.

In this study, participants, researchers, evaluators of the outcomes, and data analyzers will be blinde to the type of intervention.

Information about the main consequences will be shared.

Start the access period, 6 months after publication of results

Physicians, nutritionist, patients with anal fissure and constipation

Published as an article

Masoumeh Khalighi Sikaroudi gmail adress: masoomehkhalighi@gmail.com

mail will be sent to the main author or co-response, and in less than 1 week, the available data will send to the individual.