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

NCT05548842 | Completed

• 1 other identifier: 02-2022-010
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Constipation

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (12)

• Change in Constipation Visual Analogue Scale during 2 weeks

  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

  At the 2nd weeks after the start of the study

• Change in Visual Analogue Scale for Irritable Bowel Syndrome during 2 weeks

  At the 2nd weeks after the start of the study

• Change in Irritable Bowel Syndrome severity scoring system during 2 weeks

  At the 2nd weeks after the start of the study

• Change in Irritable Bowel Syndrome Quality of Life instrument during 2 weeks

  At the 2nd weeks after the start of the study

Study Arms (2)

Combined group

EXPERIMENTAL

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

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

Placebo group

PLACEBO COMPARATOR

This group takes placebo for 12 weeks.

Dietary Supplement: Placebo group

Interventions

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

Combined group

Placebo group DIETARY_SUPPLEMENT

Placebo 1,000 mg/day for 4 weeks

Placebo group

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \*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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, Gyeungsangnam-do, 50612, South Korea

Location

Study Officials

• Sang Yeoup Lee, MD, PhD

  Pusan National University Yangsan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 22, 2022
• Study Start: July 1, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 31, 2023
• Last Updated: April 9, 2024

Record last verified: 2024-04

Locations

KR (1)