Chronic Constipation
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTThe combined seed extracts of Cassia obtusifolia Linne and Foeniculum vulgare Mill
The combined seed extracts of Cassia obtusifolia Linne and Foeniculum vulgare Mill 1,000 mg/day for 4 weeks
DIETARY_SUPPLEMENTPlacebo group
Placebo 1,000 mg/day for 4 weeks
Sponsors
Pusan National University Yangsan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
Yes
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: * Straining during more than ¼ (25%) of defecations * Lumpy or hard stools (Bristol Stool Form Scale 1-2) more than ¼ (25%) of defecations * Sensation of incomplete evacuation more than ¼ (25%) of defecations * Sensation of anorectal obstruction/blockage more than ¼ (25%) of defecations * Manual maneuvers to facilitate more than ¼ (25%) of defecations (e.g., digital evacuation, support of the pelvic floor) * Fewer than three spontaneous bowel movements per week * Loose stools are rarely present without the use of laxatives * Insufficient criteria for irritable bowel syndrome
Exclusion criteria
* A person who is taking a constipation treatment prescribed by a doctor within 1 month from the date of screening * Those who have been taking lactobacillus or probiotics within the last 1 month * Those with secondary constipation induced by drugs or diseases. * Abnormal liver or renal function (more than twice the normal upper limit of the research institute) * Uncontrolled diabetes mellitus (\>160 mg/dL of fasting blood sugar) * Uncontrolled hypertension (\>160/100 mmHg) * Uncontrolled thyroid diseases. * Those who are taking drugs, functional foods, herbs, etc. that may affect depression * Alcohol abuser * Allergic reaction to this test food * Those who participated in other drug clinical trials within 1 month from the screening date. * Severe gastrointestinal symptoms such as heartburn and indigestion * Those who are pregnant, lactating, or plan to become pregnant during the clinical trial * Those who are judged to be unsuitable by the PI for other reasons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Colonic transit time during 2 weeks | At the 2nd weeks after the start of the study | The number of retained radiopaque markers on a Day 4 plain abdominal film |
| Change in Colonic transit time during 4 weeks | At the 4th weeks after the start of the study | The number of retained radiopaque markers on a Day 4 plain abdominal film |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual Analogue Scale for Irritable Bowel Syndrome during 2 weeks | At the 2nd weeks after the start of the study | 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. |
| Change in Irritable Bowel Syndrome severity scoring system during 2 weeks | At the 2nd weeks after the start of the study | 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. |
| Change in Irritable Bowel Syndrome Quality of Life instrument during 2 weeks | At the 2nd weeks after the start of the study | 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. |
| Change in Interferon-1β during 4 weeks | At 4th weeks after the start of the study | concentration (U/ml) |
| Change in Tumor necrosis factor-α during 4 weeks | At 4th weeks after the start of the study | concentration (pg/ml) |
| Change in Constipation Visual Analogue Scale during 2 weeks | At the 2nd weeks after the start of the study | The minimum score was 0, the maximum score was 100, and higher scores mean a worse outcome. |
| Change in Bristol stool Form scale type 3 and 4 (frequency per week) during 4 weeks | At the 4th weeks after the start of the study | Frequency of Bristol stool Form scale types 3 and 4 per week |
| Change in Visual Analogue Scale for Irritable Bowel Syndrome during 4 weeks | At the 4th weeks after the start of the study | 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. |
| Change in Irritable Bowel Syndrome severity scoring system during 4 weeks | At the 4th weeks after the start of the study | 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. |
| Change in Irritable Bowel Syndrome Quality of Life instrument during 4 weeks | At the 4th weeks after the start of the study | 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. |
| Change in Constipation Visual Analogue Scale during 4 weeks | At the 4th weeks after the start of the study | The minimum score was 0, the maximum score was 100, and higher scores |
| Change in Bristol stool Form scale type 3 and 4 (frequency per week) during 2 weeks | At the 2nd weeks after the start of the study | Frequency of Bristol stool Form scale types 3 and 4 per week |
Countries
South Korea
Outcome results
None listed