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

May 19, 2018 updated by: Makan Pourmasoumi, Isfahan University of Medical Sciences
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ficus carica
45 grams Ficus carica before breakfast and lunch with 1 glass of water every day respectively (total consumption: Ficus carica 90g/d)
Other: Ficus carica
Experimental: Descurainia Sophia
30 grams Descurainia Sophia before breakfast and lunch with 1 glass of water every day respectively (total consumption: Descurainia Sophia 60g/d)
Other: Descurainia Sophia
No Intervention: controled
participants will follow their usual diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
irritable bowel syndrome constipation predominant symptom
Time Frame: 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).
4 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isfahan University of Medical Sciences

Investigators

  • Principal Investigator: makan pourmasoumi, MSc, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

September 21, 2015

First Submitted That Met QC Criteria

September 23, 2015

First Posted (Estimate)

September 24, 2015

Study Record Updates

Last Update Posted (Actual)

May 22, 2018

Last Update Submitted That Met QC Criteria

May 19, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • makan.pourmasoumi@gmail.com

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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