Constipation associated with Irritable Bowel Syndrome
Conditions
Interventions
Participants will be randomized into two arms. The intervention arm will receive the active agent (Thriphala®) to be taken orally, 1-2 tablets at night (depending on the level of symptoms), for a per
Sponsors
Link Natural Products (PVT) Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with diagnosed IBS-C using Rome III criteria for the last 3 months, with symptom onset at least 6 months prior to diagnosis 2. Male and females aged 18 to 80 years 3. Females of child-bearing potential who consent to employ an adequate method of contraception and undergo a pregnancy test at Randomisation Visit 4. Willingness and competency to complete the entire study and comply with study instructions. 5. Patients > 50 years old have to have undergone a colonoscopy or computerised tomography (CT) after the onset of their IBS-C symptoms or within the last 5 years. 6. Less than 3 spontaneous bowel movements during the last 7 days of the run-in period
Exclusion criteria
Exclusion criteria: 1. History or evidence of organic disease in the large bowel, intestinal perforation or obstruction due to structural or functional disorder of the gut wall, ileus, severe inflammatory conditions of the intestinal tract such as Crohn's disease, complicated diverticulitis, ulcerative colitis, toxic megacolon and occlusive or subocclusive syndrome. 2. Abdominal pain of unknown cause, not related to IBS. 3. Previous major abdominal surgery. 4. IBS subtypes other than IBS-C (symptoms of IBS-diarrhoea (IBS-D) or IBS-mixed (IBS-M) 5. Known hypersensitivity to any of the active substances. 6. Laxative, drug or alcohol abuse (recent history or within previous 12 months) 7. Pregnant or lactating females. 8. Severe or acute disease within 2 weeks prior to the start of the study. 9. Type I or II diabetes 10. Use of other investigational drug s, prescribed or OTC medications affecting gastrointestinal function (anticholinergics, prokinetics, drugs affecting motility, anthraquinones. opioids,ondansetron or other 5-HT3 antagonists). 11. Incomplete Patient Diary Card during the run-in period. 12. Occurrence of diarrhoea during the run-in period. 13. Patients with abnormal laboratory tests, proctoscopy /abdominal ultrasound, colonoscopy, sigmoidoscopy or CT requiring further investigation. 14. Any condition, which, in the Investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the results of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean number of spontaneous bowel movements [Measured in the 7-day period prior to completion of 56 days of treatment] | — |
Secondary
| Measure | Time frame |
|---|---|
| Effect of treatment on other symptoms of IBS (abdominal pain, abdominal bloating, straining and feeling of incomplete evacuation) [During the 14th, 28th, 49th, 56th days follwing initiation of the study] Effect of treatment on patient's Quality of Life (using a standard questionnaire – IBS-QOL) [During the 14th, 28th, 49th, 56th days follwing initiation of the study] To evaluate the safety of treatment (using a predetermined questionnaire, assessing specific adverse effects of Thriphala®) [During the 14th, 28th, 49th, 56th days follwing initiation of the study ] To evaluate incidence of adverse events [During the 14th, 28th, 49th, 56th days follwing initiation of the study ] To evaluate compliance (using a pill count) [During the 14th, 28th, 49th, 56th days follwing initiation of the study ] To evaluate the use of rescue medication [During the 14th, 28th, 49th, 56th days follwing initiation of the study ] | — |
Countries
Sri Lanka
Contacts
Public ContactDr Madunil A Niriella
Senior Lecturer and Consultant Gastroenterologist
Outcome results
None listed