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

Study Overview
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Brief Summary
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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.

Conditions
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Irritable Bowel Syndrome Predominant Constipation

Intervention / Treatment
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* Other: Descurainia Sophia
* Other: Ficus carica


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ficus carica<br>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<br> <br> |
| Experimental: Descurainia Sophia<br>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<br> <br> |
| No Intervention: controled<br>participants will follow their usual diet | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |