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

Primary Purpose

Chronic Constipation

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
The combined seed extracts of Cassia obtusifolia Linne and Foeniculum vulgare Mill
Placebo group
Sponsored by
Pusan National University Yangsan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Constipation

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Pusan National University Yangsan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Combined group

Placebo group

Arm Description

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

This group takes placebo for 12 weeks.

Outcomes

Primary Outcome Measures

Change in Colonic transit time during 2 weeks
The number of retained radiopaque markers on a Day 4 plain abdominal film
Change in Colonic transit time during 4 weeks
The number of retained radiopaque markers on a Day 4 plain abdominal film

Secondary Outcome Measures

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.
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
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.
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.
Change in Irritable Bowel Syndrome Quality of Life instrument during 2 weeks
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
concentration (U/ml)
Change in Tumor necrosis factor-α during 4 weeks
concentration (pg/ml)
Change in Constipation Visual Analogue Scale during 4 weeks
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 4 weeks
Frequency of Bristol stool Form scale types 3 and 4 per week
Change in Visual Analogue Scale for Irritable Bowel Syndrome during 4 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.
Change in Irritable Bowel Syndrome severity scoring system during 4 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.
Change in Irritable Bowel Syndrome Quality of Life instrument during 4 weeks
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.

Full Information

First Posted
September 14, 2022
Last Updated
October 13, 2023
Sponsor
Pusan National University Yangsan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05548842
Brief Title
The Combined Seed Extracts of Cassia Obtusifolia Linne and Foeniculum Vulgare Mill in Patients With Chronic Constipation
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University Yangsan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Constipation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combined group
Arm Type
Experimental
Arm Description
This group takes the combined seed extracts of Cassia obtusifolia Linne and Foeniculum vulgare Mill for 12 weeks.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
This group takes placebo for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
The combined seed extracts of Cassia obtusifolia Linne and Foeniculum vulgare Mill
Intervention Description
The combined seed extracts of Cassia obtusifolia Linne and Foeniculum vulgare Mill 1,000 mg/day for 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo group
Intervention Description
Placebo 1,000 mg/day for 4 weeks
Primary Outcome Measure Information:
Title
Change in Colonic transit time during 2 weeks
Description
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
Title
Change in Colonic transit time during 4 weeks
Description
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 Outcome Measure Information:
Title
Change in Constipation Visual Analogue Scale during 2 weeks
Description
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
Title
Change in Bristol stool Form scale type 3 and 4 (frequency per week) during 2 weeks
Description
Frequency of Bristol stool Form scale types 3 and 4 per week
Time Frame
At the 2nd weeks after the start of the study
Title
Change in Visual Analogue Scale for Irritable Bowel Syndrome during 2 weeks
Description
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
Title
Change in Irritable Bowel Syndrome severity scoring system during 2 weeks
Description
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
Title
Change in Irritable Bowel Syndrome Quality of Life instrument during 2 weeks
Description
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.
Time Frame
At the 2nd weeks after the start of the study
Title
Change in Interferon-1β during 4 weeks
Description
concentration (U/ml)
Time Frame
At 4th weeks after the start of the study
Title
Change in Tumor necrosis factor-α during 4 weeks
Description
concentration (pg/ml)
Time Frame
At 4th weeks after the start of the study
Title
Change in Constipation Visual Analogue Scale during 4 weeks
Description
The minimum score was 0, the maximum score was 100, and higher scores
Time Frame
At the 4th weeks after the start of the study
Title
Change in Bristol stool Form scale type 3 and 4 (frequency per week) during 4 weeks
Description
Frequency of Bristol stool Form scale types 3 and 4 per week
Time Frame
At the 4th weeks after the start of the study
Title
Change in Visual Analogue Scale for Irritable Bowel Syndrome during 4 weeks
Description
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 4th weeks after the start of the study
Title
Change in Irritable Bowel Syndrome severity scoring system during 4 weeks
Description
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 4th weeks after the start of the study
Title
Change in Irritable Bowel Syndrome Quality of Life instrument during 4 weeks
Description
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.
Time Frame
At the 4th weeks after the start of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sang Yeoup Lee, MD, PhD
Phone
360-2860
Ext
055
Email
saylee@pnu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ye Li Lee
Phone
360-2860
Ext
055
Email
yeri1230@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang Yeoup Lee, MD, PhD
Organizational Affiliation
Pusan National University Yangsan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
State/Province
Gyeungsangnam-do
ZIP/Postal Code
50612
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Yeoup Lee, MD
Phone
360-1442
Ext
055
Email
saylee@pnu.edu
First Name & Middle Initial & Last Name & Degree
Ye Li Lee
Phone
360-2860
Ext
055
Email
saylee@pnu.edu

12. IPD Sharing Statement

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

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