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

NCT ID: NCT05548842

Last Updated: 2024-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2023-12-31

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.

Conditions

Chronic Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Combined group

This group takes the combined seed extracts of Cassia obtusifolia Linne and Foeniculum vulgare Mill for 12 weeks.

Group Type: EXPERIMENTAL

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

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo group

This group takes placebo for 12 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo group

Intervention Type: DIETARY_SUPPLEMENT

Placebo 1,000 mg/day for 4 weeks

Interventions

The 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

Intervention Type: DIETARY_SUPPLEMENT

Placebo group

Placebo 1,000 mg/day for 4 weeks

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pusan National University Yangsan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sang Yeoup Lee

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sang Yeoup Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Pusan National University Yangsan Hospital

Locations

Pusan National University Yangsan Hospital

Yangsan, Gyeungsangnam-do, South Korea

Countries

South Korea

Other Identifiers

02-2022-010

Identifier Type: -

Identifier Source: org_study_id