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

Evaluation of Efficacy and Safety of the Combined Seed Extracts of Cassia Obtusifolia Linne and Foeniculum Vulgare Mill in Patients With Chronic Constipation: a Double-blind, Randomized, Placebo-controlled Study

Sponsors

Lead Sponsor: Pusan National University Yangsan Hospital

Source Pusan National University Yangsan Hospital
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.

Overall Status Recruiting
Start Date 2022-07-01
Completion Date 2023-06-30
Primary Completion Date 2023-06-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in Colonic transit time during 2 weeks At the 2nd weeks after the start of the study
Change in Colonic transit time during 4 weeks At the 4th weeks after the start of the study
Secondary Outcome
Measure Time Frame
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
Change in Interferon-1β during 4 weeks At 4th weeks after the start of the study
Change in Tumor necrosis factor-α during 4 weeks At 4th weeks after the start of the study
Change in Constipation Visual Analogue Scale during 4 weeks 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 At the 4th weeks after the start of the study
Change in Visual Analogue Scale for Irritable Bowel Syndrome during 4 weeks At the 4th weeks after the start of the study
Change in Irritable Bowel Syndrome severity scoring system during 4 weeks At the 4th weeks after the start of the study
Change in Irritable Bowel Syndrome Quality of Life instrument during 4 weeks At the 4th weeks after the start of the study
Enrollment 100
Condition
Intervention

Intervention Type: Dietary Supplement

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

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

Arm Group Label: Combined group

Intervention Type: Dietary Supplement

Intervention Name: Placebo group

Description: Placebo 1,000 mg/day for 4 weeks

Arm Group Label: Placebo group

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

Gender:

All

Minimum Age:

19 Years

Maximum Age:

75 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Sang Yeoup Lee, MD, PhD Principal Investigator Pusan National University Yangsan Hospital
Overall Contact

Last Name: Sang Yeoup Lee, MD, PhD

Phone: 360-2860

Phone Ext.: 055

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Pusan National University Yangsan Hospital Sang Yeoup Lee, MD 360-1442 055 [email protected]
Location Countries

Korea, Republic of

Verification Date

2022-09-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Pusan National University Yangsan Hospital

Investigator Full Name: Sang Yeoup Lee

Investigator Title: Professor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Combined group

Type: Experimental

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

Label: Placebo group

Type: Placebo Comparator

Description: This group takes placebo for 12 weeks.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

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