Effect of Flixweed and Fig on Irritable Bowel Syndrome With Predominant Constipation: a Single Blind Randomized Clinical Trial.

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome Predominant Constipation
• Interventions: Other: Ficus carica; Other: Descurainia Sophia

• Registration Number: NCT02559245
• Lead Sponsor: Isfahan University of Medical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-21
• Study First Submitted QC: 2015-09-23
• Study First Posted: 2015-09-24
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-19
• Last Update Posted: 2018-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ficus carica	Ficus carica	45 grams Ficus carica before breakfast and lunch with 1 glass of water every day respectively (total consumption: Ficus carica 90g/d)
Descurainia Sophia	Descurainia Sophia	30 grams Descurainia Sophia before breakfast and lunch with 1 glass of water every day respectively (total consumption: Descurainia Sophia 60g/d)

Primary Outcome Measures

Name	Time	Method
irritable bowel syndrome constipation predominant symptom	4 months	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).

Secondary Outcome Measures

Name	Time	Method
quality of life in IBS-C patients	4 months	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.
frequency of defecation and hard stool	4 months	frequency of defecation and hard stool was evaluated at baseline and end of every month using the visual analogue scale (VAS)

Trial Locations

Locations (1)

Gastrointestinal Research Center; 🇮🇷 Isfahan, Iran, Islamic Republic of