Evaluation of the efficacy of Valerian and placebo in patients with irritable bowel syndrome

Assessment of effect of valerian on irritable bowel syndrome (IBS)

A phase 2 clinical trial on 40 patients, with a control group, parallel groups, double-blind, randomized design. For simple randomization random.org website wasused.

In this study, patients suffering from IBS who are admitted to Booali hospital in Tehran and have the inclusion criteria, will enter to the study. Patients will be divided randomly in two groups. In the intervention group, Sedamin capsouls daily and in control group one placebo capsoul a day will be added to the main treatment regimen for 4 weeks. Abdominal pain (severity of pain and Duration of pain),Abdominal distension (bloating,swollen or tight tummy), Satisfaction with fecal excretion, Improving patients symptoms and Quality of life is assessed by the questionnaire before the intervention and one months after the intervention and will be completely reviewed at the end of the study.

Inclution criteria: Patients with irritable bowel syndrome based on Rome IV criteria Age between 18-65 years old Informed consent. Exclution criteria: Pregnant women, Lactating women, Having liver and kidney failure, Having an allergy or previous side effects to Valerian, Having diabetes, People receiving neuroleptics, People taking valerian other than our study program

Intervention group: In this group, patients will receive Sedamin capsules (Contains 530 mg Valerian) produced by Goldaru Pharmaceutical Company (Tehran, Iran) once a day for 4 weeks in addition to their standard treatment.

Abdominal pain (severity of pain and duration of pain); Abdominal distension (bloating, swollen or tight tummy); Satisfaction with fecal excretion; The impact of the IBS on the Patient's Quality of Life; Irritable Bowel Syndrome Severity Score

Random number table: Two groups of 30 patients were made using simple randomization method, based on Random Sequence Generator via www.random.org website. For Random Allocation concealment, the method of opaque sealed envelopes with random sequence was used. Patients were allocated in one of two groups based on their entry sequence.

In this study both researcher and patients are not aware which medication the patient is using. Drugs will be dispensed by researcher in uniform packages with unique codes.

Information about the primary outcome will be shared after Deidentification of Individual Participant Data

after publication of paper,for two years

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