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| ID | Type | Description | Link |
|---|---|---|---|
| Dr.Mosaffa | Registry Identifier | Dr.Mosaffa |
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Colpermin Ā® (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.
The purpose of this study is to assess the efficacy of Enteric-coated Anise-oil capsules comparing with placebo and ColperminĀ® 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 (ColperminĀ® Capsule once daily, for 4 weeks). At the end of therapy (4 weeks) and at baseline (first), 2 weeks after receiving drug, placebo and ColperminĀ® IBS load, will be evaluated and compared between groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| ColperminĀ® | Active Comparator | ColperminĀ® Group: One ColperminĀ® Capsule/Day for 4 Weeks. Patients Will be Followed at Baseline, 4 and 6 Weeks after Starting Intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anise-oil EC Capsule | Drug | Anise-oil EC Capsule,One Cap(187mg)/day for 4 Weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Composite of Quality of Life (QOL), pain, flatulence, diarrhea, constipation, reflux, headache and tiredness | (IBS-QOL) questionnaire and 10-point visual scale ranging | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maryam Mosaffa-Jahromi, PhDc | Department of Traditional Pharmacy, School of Pharmacy and Pharmaceutical Sciences Research Center, Shiraz University of Medical Sciences, Shiraz, Iran | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Kamran Bagheri Lankarani | Shiraz | Fars | Iran | |||
| Dr. Maryam Mosaffa-Jahromi |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| Placebo | Other | One Placebo Capsule/Day for 4 Weeks |
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| ColperminĀ® | Drug | ColperminĀ® Capsule/Day for 4 Weeks |
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(IBS-QOL) questionnaire and 10-point visual scale ranging |
| End of Follow Up(6 weeks after staring intervention) |
| Shiraz |
| Fars |
| Iran |
| D004066 | Digestive System Diseases |