Irritable Bowel SyndromePhase 3IBS-AniseNCT02364830
Clinical Effectiveness of Enteric Coated(E.C.) Anise-oil on Irritable Bowel Syndrome
A Phase 3 study testing Anise-oil EC Capsule and Colpermin® in people with Irritable Bowel Syndrome, run by Shiraz University of Medical Sciences at 2 sites in Iran.
Trial summary
Colpermin ® (Peppermint oil) is used in the treatment of Irritable Bowel Syndrome but Peppermint (Mentha x piperita) isn't native in Iran. So in this study the Enteric-Coated of Anise-oil will formulate and use in treatment of Irritable Bowel Syndrome with pain and bloating. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Anise-oil EC Capsule and Colpermin®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesIran
- Study dates
- Apr 2013to Jan 2015
- Phase
- Phase 3
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Meeting the Rome III Modular Questionnaire
- Patients with 50 years were required to have a colonoscopy performed within the previous 5 years
- Patients under the age of 50 years were required to have a sigmoidoscopy performed
Who cannot join
- Unable or unwilling patients to use an acceptable method of birth control
- Pregnant or nursing females
- Previous gastrointestinal or abdominal surgery (except for common causes unrelated to IBS)
- Organic disorder of the large or small bowel (e.g. ulcerative colitis, Crohn's disease)
- Mechanical obstruction
- Unexplained significant weight loss or rectal bleeding
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- Diagnosis of any medical condition associated with constipation (other than IBS)
- Cancer
- Abnormal laboratory tests
- Abuse of alcohol or drugs
Trial locations and contacts
2 sites in 1 country.
Iran2 sites
Dr. Kamran Bagheri Lankarani
Shiraz, Fars
Dr. Maryam Mosaffa-Jahromi
Shiraz, Fars
About this study
Official title: Randomised Clinical Trial: Enteric-coated Anise-oil Capsules vs. Placebo & Active Controlled in Irritable Bowel Syndrome - A 4 Week Double-blind Study With 2 Weeks Follow-up
Colpermin ® (Peppermint oil) is used in the treatment of Irritable Bowel Syndrome but Peppermint (Mentha x piperita) isn't native in Iran. So in this study the Enteric-Coated of Anise-oil will formulate and use in treatment of Irritable Bowel Syndrome with pain and bloating.
Read the detailed description
The purpose of this study is to assess the efficacy of Enteric-coated Anise-oil capsules comparing with placebo and Colpermin® for treatment of IBS patients. 120 patients with confirmed IBS with non-response criteria selected. In this double blind pilot study, the patients and researchers will be blinded about Receiving Drug, Placebo and Active allocation. Patients will be randomized into group A (Anise-oil EC Capsule 187 mg daily, for 4 weeks), group B (placebo Capsule once daily, for 4 weeks) and group B (Colpermin® Capsule once daily, for 4 weeks). At the end of therapy (4 weeks) and at baseline (first), 2 weeks after receiving drug, placebo and Colpermin® IBS load, will be evaluated and compared between groups.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Anise-oil EC Capsule, Placebo, Colpermin®
- Keywords
- Pimpinella anisum L., Peppermint oil, Irritable Bowel Syndrome
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anise-oil EC CapsuleDrug
Also called Group A
Anise-oil EC Capsule,One Cap(187mg)/day for 4 Weeks
PlaceboOther
Also called Group B
One Placebo Capsule/Day for 4 Weeks
Colpermin®Drug
Also called Group C
Colpermin® Capsule/Day for 4 Weeks
| Study group | Role | What they receive |
|---|---|---|
| Anise-oil EC | Active comparator | Intervention Group: Anise-oil EC Capsule,One Cap(187mg)/day for 4 weeks. Patients will be Followed at Baseline, 4 and 6 Weeks after Starting Intervention. Receives: Drug: Anise-oil EC Capsule |
| Placebo | Placebo comparator | Placebo Group: One Placebo Capsule/Day for 4 Weeks. Patients Will be Followed at Baseline, 4 and 6 Weeks after Starting Intervention. Receives: Other: Placebo |
| Colpermin® | Active comparator | Colpermin® Group: One Colpermin® Capsule/Day for 4 Weeks. Patients Will be Followed at Baseline, 4 and 6 Weeks after Starting Intervention. Receives: Drug: Colpermin® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of Quality of Life (QOL), pain, flatulence, diarrhea, constipation, reflux, headache and tiredness
(IBS-QOL) questionnaire and 10-point visual scale ranging
Measured: Baseline
Secondary outcomes (2)
Composite of Change in Quality of Life (QOL), pain, flatulence, diarrhea, constipation, reflux, headache and tiredness at end of treatment
(IBS-QOL) questionnaire and 10-point visual scale ranging
Measured: 4 weeks after start treatment
Composite of Change in Quality of Life (QOL), pain, flatulence, diarrhea, constipation, reflux, headache and tiredness at end of treatment
(IBS-QOL) questionnaire and 10-point visual scale ranging
Measured: End of Follow Up(6 weeks after staring intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study startApr 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Maryam Mosaffa-Jahromi, Shiraz University of Medical Sciences
- Investigators
- Maryam Mosaffa-Jahromi, PhDc, Principal investigator, Department of Traditional Pharmacy, School of Pharmacy and Pharmaceutical Sciences Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02364830
- Sponsor's protocol ID
- E.C. Anise-oil on IBS
- Other IDs
- Dr.Mosaffa
- Acronym
- IBS-Anise
- Status last verified
- Feb 2015
- First submitted
- 5 Feb 2015
- Last updated
- 18 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Clinical Trial: Enteric-coated Anise-oil Capsules vs. Placebo & Active Controlled in Irritable Bowel Syndrome - A 4 Week Double-blind Study With 2 Weeks Follow-up
- ClinicalTrials.gov ID
- NCT02364830
- Acronym / sponsor ID
- IBS-Anise / E.C. Anise-oil on IBS
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Pimpinella anisum L., Peppermint oil, Irritable Bowel Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 18 Feb 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.
Colpermin ® (Peppermint oil) is used in the treatment of Irritable Bowel Syndrome but Peppermint (Mentha x piperita) isn't native in Iran. So in this study the Enteric-Coated of Anise-oil will formulate and use in treatment of Irritable Bowel Syndrome with pain and bloating.
Detailed description
The purpose of this study is to assess the efficacy of Enteric-coated Anise-oil capsules comparing with placebo and Colpermin® for treatment of IBS patients. 120 patients with confirmed IBS with non-response criteria selected. In this double blind pilot study, the patients and researchers will be blinded about Receiving Drug, Placebo and Active allocation. Patients will be randomized into group A (Anise-oil EC Capsule 187 mg daily, for 4 weeks), group B (placebo Capsule once daily, for 4 weeks) and group B (Colpermin® Capsule once daily, for 4 weeks). At the end of therapy (4 weeks) and at baseline (first), 2 weeks after receiving drug, placebo and Colpermin® IBS load, will be evaluated and compared between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anise-oil EC | Active comparator | Drug: Anise-oil EC CapsuleIntervention Group: Anise-oil EC Capsule,One Cap(187mg)/day for 4 weeks. Patients will be Followed at Baseline, 4 and 6 Weeks after Starting Intervention. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo Group: One Placebo Capsule/Day for 4 Weeks. Patients Will be Followed at Baseline, 4 and 6 Weeks after Starting Intervention. |
| Colpermin® | Active comparator | Drug: Colpermin®Colpermin® Group: One Colpermin® Capsule/Day for 4 Weeks. Patients Will be Followed at Baseline, 4 and 6 Weeks after Starting Intervention. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Meeting the Rome III Modular Questionnaire
- Patients with 50 years were required to have a colonoscopy performed within the previous 5 years
- Patients under the age of 50 years were required to have a sigmoidoscopy performed
Key exclusion criteria (10 listed)
- Unable or unwilling patients to use an acceptable method of birth control
- Pregnant or nursing females
- Previous gastrointestinal or abdominal surgery (except for common causes unrelated to IBS)
- Organic disorder of the large or small bowel (e.g. ulcerative colitis, Crohn's disease)
- Mechanical obstruction
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 |
|---|---|---|
| Anise-oil EC CapsuleAlso: Group AAnise-oil EC Capsule,One Cap(187mg)/day for 4 Weeks | Drug | Anise-oil EC |
| PlaceboAlso: Group BOne Placebo Capsule/Day for 4 Weeks | Other | Placebo |
| Colpermin®Also: Group CColpermin® Capsule/Day for 4 Weeks | Drug | Colpermin® |
Primary outcome
Composite of Quality of Life (QOL), pain, flatulence, diarrhea, constipation, reflux, headache and tiredness
Time frame: Baseline
(IBS-QOL) questionnaire and 10-point visual scale ranging
2 secondary outcomes
Composite of Change in Quality of Life (QOL), pain, flatulence, diarrhea, constipation, reflux, headache and tiredness at end of treatment
Time frame: 4 weeks after start treatment
Composite of Change in Quality of Life (QOL), pain, flatulence, diarrhea, constipation, reflux, headache and tiredness at end of treatment
Time frame: End of Follow Up(6 weeks after staring intervention)
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 18 Feb 2015.
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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.
Maryam Mosaffa-Jahromi, PhDc principal investigator
Department of Traditional Pharmacy, School of Pharmacy and Pharmaceutical Sciences Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anise-oil EC Capsule and Colpermin® in people with Irritable Bowel Syndrome, run by Shiraz University of Medical Sciences at 2 sites 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 3 inclusion and 10 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 18 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Composite of Quality of Life (QOL), pain, flatulence, diarrhea, constipation, reflux, headache and tiredness (time frame: Baseline). 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 18 Feb 2015.