Herbal drug for treatment of Irritable bowel syndrome (IBS)
Phase 2
- Conditions
- Irritable bowel syndrome.Irritable bowel syndrome
- Registration Number
- IRCT2016072629026N3
- Lead Sponsor
- Hormozgan Science & Technology Park
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Written consent and complete knowledge about the study.
Being diagnosed with Irritable bowel syndrome based on the ROME III criteria.
Exclusion Criteria
The participants’ lack of consent to continue their participation in the study.
Kidney and liver diseases based on laboratory tests.
Warning symptoms of gastric and intestinal cancers, other chronic digestive diseases and peptic ulcer disease based on patient history, physical examination and medical records.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Quality of life. Timepoint: Before intervention, end of intervention and 2 weeks after intervention. Method of measurement: IBS Quality of life(IBS-QOL).;Relife of symptoms. Timepoint: End of intervention and 2 weeks after intervention. Method of measurement: IBS Adequate relief (IBS-AR).;Relife of symptoms. Timepoint: End of intervention and 2 weeks after intervention. Method of measurement: IBS Global Assessment improvement(IBS-GAI).;Average score of IBS Symptom Severity Scale(IBS-SSS). Timepoint: Before intervention, end of intervention and 2 weeks after intervention. Method of measurement: IBS Symptom Severity Scale(IBS-SSS).
- Secondary Outcome Measures
Name Time Method Amount of drug consumption. Timepoint: After intervention. Method of measurement: By checking the residual amount of drug after intervention.;Liver enzymes disorder. Timepoint: Before and after intervention. Method of measurement: Labratory test(AST,ALT,ALP,Billi T,D).;Renal dysfunction. Timepoint: Before and after intervention. Method of measurement: Labratory test(BUN,Cr).;Drug side effects. Timepoint: During and after intervention. Method of measurement: Entry the side effects by patient and clinical caregiver in side effects form.