Irritable Bowel Syndrome Predominant Constipation Clinical Trial
| Verified date | May 2018 |
| Source | Isfahan University of Medical Sciences |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study evaluates effect of Ficus carica and Descurainia Sophia on irritable bowel syndrome predominant constipation. one-third of patients will receive Ficus carica, another one-third will receive Descurainia Sophia and remained patients only will follow their regular diet for 4 months.
| Status | Completed |
| Enrollment | 150 |
| Est. completion date | January 2016 |
| Est. primary completion date | January 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - patients with irritable bowel syndrome predominant constipation Exclusion Criteria: - Subjects with significant cardiovascular, renal, hepatic, pulmonary, endocrine, metabolic, hematologic disorders, - structural abnormalities of the gastrointestinal tract or - diseases /conditions that affected bowel transition, - surgery, - any prokinetic or laxative drug used during the past month, - any medication that may affect gastrointestinal motility, - other therapeutic dietary advice for IBS, - used Fig or Flixweed during the last month, - diarrhea, - pregnancy or - breast-feeding |
| Country | Name | City | State |
|---|---|---|---|
| Iran, Islamic Republic of | Gastrointestinal Research Center | Isfahan |
| Lead Sponsor | Collaborator |
|---|---|
| Isfahan University of Medical Sciences |
Iran, Islamic Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | irritable bowel syndrome constipation predominant symptom | IBS severity score system questionnaires will use for evaluation of IBS-C symptoms at the pre and post-intervention. This tool is validated for use in IBS patients that assess 5 clinically relevant items during past 10-days and including severity of abdominal pain, frequency of abdominal pain, severity of abdominal distention, dissatisfaction with bowel movement and interference of IBS with life in general. Each items was scored with a 100 mm visual analogue scale (VAS). | 4 months | |
| Secondary | quality of life in IBS-C patients | quality of life in IBS-C patients were assessed at pre-and post-intervention using a self-report Irritable Bowel Syndrome-Quality of Life Measure (IBS-QoL). It contains 34 items with 8 sub-classification including dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual, and relationships. The sum of response to this items by every subject were average and transform to 0-100 scale. The higher score indicated better quality of life among IBS-C patients. | 4 months | |
| Secondary | frequency of defecation and hard stool | frequency of defecation and hard stool was evaluated at baseline and end of every month using the visual analogue scale (VAS) | 4 months |