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

Primary Purpose

Irritable Bowel Syndrome Predominant Constipation

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Descurainia Sophia
Ficus carica
Sponsored by
Isfahan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome Predominant Constipation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Gastrointestinal Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Ficus carica

Descurainia Sophia

controled

Arm Description

45 grams Ficus carica before breakfast and lunch with 1 glass of water every day respectively (total consumption: Ficus carica 90g/d)

30 grams Descurainia Sophia before breakfast and lunch with 1 glass of water every day respectively (total consumption: Descurainia Sophia 60g/d)

participants will follow their usual diet

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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)

Full Information

First Posted
September 21, 2015
Last Updated
May 19, 2018
Sponsor
Isfahan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02559245
Brief Title
Effect of Flixweed and Fig on Irritable Bowel Syndrome With Predominant Constipation: a Single Blind Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome Predominant Constipation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ficus carica
Arm Type
Experimental
Arm Description
45 grams Ficus carica before breakfast and lunch with 1 glass of water every day respectively (total consumption: Ficus carica 90g/d)
Arm Title
Descurainia Sophia
Arm Type
Experimental
Arm Description
30 grams Descurainia Sophia before breakfast and lunch with 1 glass of water every day respectively (total consumption: Descurainia Sophia 60g/d)
Arm Title
controled
Arm Type
No Intervention
Arm Description
participants will follow their usual diet
Intervention Type
Other
Intervention Name(s)
Descurainia Sophia
Intervention Type
Other
Intervention Name(s)
Ficus carica
Primary Outcome Measure Information:
Title
irritable bowel syndrome constipation predominant symptom
Description
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).
Time Frame
4 months
Secondary Outcome Measure Information:
Title
quality of life in IBS-C patients
Description
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.
Time Frame
4 months
Title
frequency of defecation and hard stool
Description
frequency of defecation and hard stool was evaluated at baseline and end of every month using the visual analogue scale (VAS)
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
makan pourmasoumi, MSc
Organizational Affiliation
Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gastrointestinal Research Center
City
Isfahan
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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