Efficacy of formula of Plantago major, and Rheum khorasanicum on clinical symptoms of patient with mild to moderate ulcerative colitis: a double blind randomized clinical trial

Determining the effect of the traditional product of Plantago major, and Rheum on the clinical symptoms of mild to moderate ulcerative colitis patients compared to placebo

The clinical trial has a control group, double-blind, randomized, on 60 patients, randomly block in 4 blocks of four

Two groups of 30 patients in Kerman University of Medical Sciences, who were assigned randomly (random block) to the drug and placebo groups, follow-up and the desired response will be recorded at the beginning of the study, 3, 6 and 10 weeks.

Inclusion criteria: patients aged 18 to 60 with mild and moderate ulcerative colitis confirmed by Endoscopy and biopsy and with the diagnosis of gastroenterologist who signed the informed consent form have no exclusion criteria. Exclusion criteria: pregnancy or breastfeeding; use of antibiotics; NSAIDs OCPs or hormone therapy (in the last 2 weeks); suffering from disease complications; simultaneous suffering from serious diseases Liver, kidney, heart, cancer or celiac disease; smoking or drug addiction; suffering from other diseases Autoimmunity; simultaneous use of other traditional medicine and complementary medicine.

Intervention group: consumes 2 capsules daily (1 in the morning and 1 in the evening) before meals. The capsule contains 2 parts of gourd extract and one part of rhubarb extract. Control group: consumes 2 capsules daily (1 in the morning and 1 in the evening). The capsule contains an equal volume of corn starch.

Partial Mayo score; Quality of Life; anxiety; depression; Stress

Patients with mild to moderate ulcerative colitis based on Partial Mayo score, and inclusion, and exclusion criteria, will be entered into Excel file (Microsoft Excel® software 2021), then randomly sorted through using "RAND", and "INDEX" formulas. Then, simple randomized patients, in the order of the list of excel, will be entered into the two groups of the study (drug, or placebo) according to the list of 6 blocks of 4 below (ABAB, BABA, ABBA, BAAB, AABB, BBAA) by a trained secretory, who is blinded in details of the study, based on randomized excel file.

Medicines and placebos are prepared by a traditional pharmacy specialist in the laboratory of the Iranian Faculty of Medicine, and after homogenization in terms of shape, smell, and color, they are provided to the researcher in completely similar packages.