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The investigators will conduct a randomized, double-blind, placebo-controlled study to investigate the effects and safety of the combination seed extracts of Cassia obtusifolia Linne and Foeniculum vulgare Mill in patients with chronic constipation for 4 weeks.
A previous animal study has indicated that the combined seed extracts of Cassia obtusifolia Linne and Foeniculum vulgare Mill have a laxative effect by recovering stool parameters, colonic morphology, and activation of mAchRs and their downstream signaling pathway in constipation. Furthermore, this study provides that the combined seed extracts of Cassia obtusifolia Linne and Foeniculum vulgare Mill could be considered as a therapeutic drug candidate for the prevention or treatment of constipation. Therefore, the investigators a randomized, double-blind, placebo-controlled study to investigate the effects and safety of the combination seed extracts of Cassia obtusifolia Linne and Foeniculum vulgare Mill in patients with chronic constipation for 4 weeks. The Investigators examine stool transit time, constipation Visual Analogue Scale (VAS), Bristol stool Form scale type 3 and 4 (frequency per week), VAS for Irritable Bowel Syndrome (VAS-IBS) questionnaire, IBS severity scoring system, BS Quality of Life instrument at baseline, as well as after 2 and 4 weeks of intervention. Interferon-1β and tumor necrosis factor-α concentrations were measured at baseline and 4 weeks. One hundred adults were administered either 1,000 mg of the combined seed extracts of Cassia obtusifolia Linne and Foeniculum vulgare Mill or a placebo each day for 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined group | Experimental | This group takes the combined seed extracts of Cassia obtusifolia Linne and Foeniculum vulgare Mill for 12 weeks. |
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| Placebo group | Placebo Comparator | This group takes placebo for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The combined seed extracts of Cassia obtusifolia Linne and Foeniculum vulgare Mill | Dietary Supplement | The combined seed extracts of Cassia obtusifolia Linne and Foeniculum vulgare Mill 1,000 mg/day for 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Colonic transit time during 2 weeks | The number of retained radiopaque markers on a Day 4 plain abdominal film | At the 2nd weeks after the start of the study |
| Change in Colonic transit time during 4 weeks | The number of retained radiopaque markers on a Day 4 plain abdominal film | At the 4th weeks after the start of the study |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Constipation Visual Analogue Scale during 2 weeks | The minimum score was 0, the maximum score was 100, and higher scores mean a worse outcome. | At the 2nd weeks after the start of the study |
| Change in Bristol stool Form scale type 3 and 4 (frequency per week) during 2 weeks |
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Inclusion Criteria:
*Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis
**Must include two or more of the following:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sang Yeoup Lee, MD, PhD | Pusan National University Yangsan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University Yangsan Hospital | Yangsan | Gyeungsangnam-do | 50612 | South Korea |
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| Placebo group | Dietary Supplement | Placebo 1,000 mg/day for 4 weeks |
|
Frequency of Bristol stool Form scale types 3 and 4 per week |
| At the 2nd weeks after the start of the study |
| Change in Visual Analogue Scale for Irritable Bowel Syndrome during 2 weeks | All except item 1 are rated from 0 to 100 points using the Visual Analogue Scale. A total of 700 points is obtained. Higher scores mean a better outcome. | At the 2nd weeks after the start of the study |
| Change in Irritable Bowel Syndrome severity scoring system during 2 weeks | Among the questions, categorical questions asking about abdominal pain or bloating are excluded from the score calculation, and the remaining 5 questions are rated from 0 to 100 points using the Visual Analogue Scale. The total score is 500 points. Higher scores mean a worse outcome. | At the 2nd weeks after the start of the study |
| Change in Irritable Bowel Syndrome Quality of Life instrument during 2 weeks | 5 points for 'not at all', 4 points for 'somewhat', 3 points for 'moderate', 2 points for 'very much', and 1 point for 'severe' (i.e., count opposite the number on the questionnaire). Higher scores indicate higher quality of life. | At the 2nd weeks after the start of the study |
| Change in Interferon-1β during 4 weeks | concentration (U/ml) | At 4th weeks after the start of the study |
| Change in Tumor necrosis factor-α during 4 weeks | concentration (pg/ml) | At 4th weeks after the start of the study |
| Change in Constipation Visual Analogue Scale during 4 weeks | The minimum score was 0, the maximum score was 100, and higher scores | At the 4th weeks after the start of the study |
| Change in Bristol stool Form scale type 3 and 4 (frequency per week) during 4 weeks | Frequency of Bristol stool Form scale types 3 and 4 per week | At the 4th weeks after the start of the study |
| Change in Visual Analogue Scale for Irritable Bowel Syndrome during 4 weeks | All except item 1 are rated from 0 to 100 points using the Visual Analogue Scale. A total of 700 points is obtained. Higher scores mean a better outcome. | At the 4th weeks after the start of the study |
| Change in Irritable Bowel Syndrome severity scoring system during 4 weeks | Among the questions, categorical questions asking about abdominal pain or bloating are excluded from the score calculation, and the remaining 5 questions are rated from 0 to 100 points using the Visual Analogue Scale. The total score is 500 points. Higher scores mean a worse outcome. | At the 4th weeks after the start of the study |
| Change in Irritable Bowel Syndrome Quality of Life instrument during 4 weeks | 5 points for 'not at all', 4 points for 'somewhat', 3 points for 'moderate', 2 points for 'very much', and 1 point for 'severe' (i.e., count opposite the number on the questionnaire). Higher scores indicate higher quality of life. | At the 4th weeks after the start of the study |