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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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20171127037640N1
Enrollment
100
Registered
2018-03-23
Start date
2018-04-04
Completion date
Unknown
Last updated
2018-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iritable bowel syndrom. Irritable bowel syndrome

Interventions

Intervention 1: Intervention group 1: First group receive Cumin powder and Mebeverin placebo capsule. Herbal powder in determined ratio consists of Cuminum cyminum L., Trachyspemum ammi (L.) Sprague,

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 65 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactKhadijeh Hatami

Tehran University of Medical Sciences

kh-hatami@razi.tums.ac.ir+98 21 8214 1600

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026