Comparing the Efficacy of Cumin Powder with Mebeverin on Severity Score and Quality of Life of the Patients Involved IBS, a Double Blind Randomized Clinical Trial

Phase 3

Conditions: Iritable bowel syndrom.
Irritable bowel syndrome

Registration Number: IRCT20171127037640N1

Lead Sponsor: Tehran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 100

Inclusion Criteria

Age:16-65 years old
IBS patients according to ROME 4 criteria, without red flags of organic diseases such as anemia, weight loss, night pin, OB positive, recent changes in bowel habit especially in patient more than 50 years old
Moderate to severe symptoms according to IBS severity score (Visual analogue scale score >24-100)
Fulfill the consent form
Ability to understand and give response exactly
Accessible and resident in Tehran
Do not have metabolic or endocrine disorders such as untreated hypothyroidism and neurologic diseases, congenital neuromuscular diseases, end organ (kidney and liver) failures, tumors and other organ failures

Exclusion Criteria

Acute or chronic mental or psychological disorders such as bipolar disorder, major depression, schizophrenia, dementia and mental retardation
Pregnancy and breast feeding
History of allergic reaction to Apiaceae family or to any part of the drug
History of addiction to alcohol or opiates in recent 6 months
History of abdominal surgery (except non complicated appendectomy), C/S, laparoscopic surgery or repair of hernia
Use of medication that has effect on bowel movement, long term use of antibiotics, anti diarrhea, laxatives, anticholinergics, opium containing drugs, resins(they could be enrolled after 1 week abstinence if they could stop their medication)
Antibiotic consumption in recent month

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in symptoms of irritable bowel syndrome according to IBS-SS questioner (irritable bowel syndrome severity score) that measure abdominal pain severity and frequency and degree of bloating and degree of satisfaction with defecation and degree of disturbance in quality of life. each variable will be measured according visual analog scale from 0-100 (in sum will be 0-500). changes in each symptom before and after treatment will be measured.? Equal or more than 50% improvement in IBS-SS will be considered response to treatment. Timepoint: Before intervention and after 1 month treatment. Method of measurement: IBS-SS questioner (irritable bowel syndrome severity score).

Secondary Outcome Measures

Name	Time	Method
IBS Quality Of Life score. Timepoint: Before intervention nd 1 month after beginning of treatment. Method of measurement: IBS-QOL questioner that measure changes in quality of life in ptients with irritable bowel syndrome. ( By means of it's Persian translated version that it's validity and reliability has been tested.).