Irritable Bowel Syndrome Predominant ConstipationNCT02559245
Effect of Flixweed and Fig on Irritable Bowel Syndrome With Predominant Constipation: a Single Blind Randomized Clinical Trial.
A study testing Descurainia Sophia and Ficus carica in people with Irritable Bowel Syndrome Predominant Constipation, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome Predominant Constipation
- What is being tested?
- Descurainia Sophia and Ficus carica
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIran
- Study dates
- Sep 2015to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients with irritable bowel syndrome predominant constipation
Who cannot join
- 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,
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- other therapeutic dietary advice for IBS,
- used Fig or Flixweed during the last month,
- diarrhea,
- pregnancy or
- breast-feeding
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Descurainia Sophia, Ficus carica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Descurainia SophiaOther
Ficus caricaOther
| Study group | Role | What they receive |
|---|---|---|
| Ficus carica | Experimental | 45 grams Ficus carica before breakfast and lunch with 1 glass of water every day respectively (total consumption: Ficus carica 90g/d) Receives: Other: Ficus carica |
| Descurainia Sophia | Experimental | 30 grams Descurainia Sophia before breakfast and lunch with 1 glass of water every day respectively (total consumption: Descurainia Sophia 60g/d) Receives: Other: Descurainia Sophia |
| controled | No intervention | participants will follow their usual diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 months
Secondary outcomes (2)
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.
Measured: 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)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel Syndrome Predominant ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Makan Pourmasoumi, Isfahan University of Medical Sciences
- Investigators
- makan pourmasoumi, MSc, Principal investigator, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02559245
- Sponsor's protocol ID
- makan.pourmasoumi@gmail.com
- Status last verified
- May 2018
- First submitted
- 21 Sep 2015
- Last updated
- 22 May 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Flixweed and Fig on Irritable Bowel Syndrome With Predominant Constipation: a Single Blind Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT02559245
- Acronym / sponsor ID
- makan.pourmasoumi@gmail.com
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 24 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ficus carica | Experimental | Other: Ficus carica45 grams Ficus carica before breakfast and lunch with 1 glass of water every day respectively (total consumption: Ficus carica 90g/d) |
| Descurainia Sophia | Experimental | Other: Descurainia Sophia30 grams Descurainia Sophia before breakfast and lunch with 1 glass of water every day respectively (total consumption: Descurainia Sophia 60g/d) |
| controled | No intervention | –participants will follow their usual diet |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with irritable bowel syndrome predominant constipation
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Descurainia Sophia | Other | Descurainia Sophia |
| Ficus carica | Other | Ficus carica |
Primary outcome
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).
2 secondary outcomes
quality of life in IBS-C patients
Time frame: 4 months
frequency of defecation and hard stool
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
makan pourmasoumi, MSc principal investigator
Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Descurainia Sophia and Ficus carica in people with Irritable Bowel Syndrome Predominant Constipation, run by Isfahan University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
irritable bowel syndrome constipation predominant symptom (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2018.