The Combined Seed Extracts of Cassia Obtusifolia Linne and Foeniculum Vulgare Mill in Patients With Chronic Constipation

Pusan National University Yangsan Hospital100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

100

Conditions

Chronic Constipation

Interventions

The combined seed extracts of Cassia obtusifolia Linne and Foeniculum vulgare MillDIETARY_SUPPLEMENT

The combined seed extracts of Cassia obtusifolia Linne and Foeniculum vulgare Mill 1,000 mg/day for 4 weeks

Placebo groupDIETARY_SUPPLEMENT

Placebo 1,000 mg/day for 4 weeks

Eligibility

Sex: ALLMin age: 19 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pusan National University Yangsan Hospital

Yangsan, Gyeungsangnam-do, South Korea

Outcomes

Primary Outcomes

Change in Colonic transit time during 2 weeks

The number of retained radiopaque markers on a Day 4 plain abdominal film

Time frame: 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

Time frame: At the 4th weeks after the start of the study

Secondary Outcomes

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.

Time frame: 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

Frequency of Bristol stool Form scale types 3 and 4 per week

Time frame: 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.

Time frame: 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.

Time frame: At the 2nd weeks after the start of the study

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.