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OpenTrials
Completed

NCT Number: NCT02559245

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

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.

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Key information

Conditions

Irritable Bowel Syndrome Predominant Constipation

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gastrointestinal Research Center

Isfahan, Iran

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Descurainia Sophia

Other

Ficus carica

Other

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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)

Sponsors and collaborators

Lead sponsor

Isfahan University of Medical Sciences

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 24, 2015
Registry last updated
May 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.