Chronic ConstipationNCT05548842
The Combined Seed Extracts of Cassia Obtusifolia Linne and Foeniculum Vulgare Mill in Patients With Chronic Constipation
A study testing The combined seed extracts of Cassia obtusifolia Linne and Foeniculum vulgare Mill in people with Chronic Constipation, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Constipation
- What is being tested?
- The combined seed extracts of Cassia obtusifolia Linne and Foeniculum vulgare Mill
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Pusan National University Yangsan Hospital
Yangsan, Gyeungsangnam-do, 50612
About this study
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
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.
Read the 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
- Being tested
- The combined seed extracts of Cassia obtusifolia Linne and Foeniculum vulgare Mill, Placebo group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Combined group | Experimental | This group takes the combined seed extracts of Cassia obtusifolia Linne and Foeniculum vulgare Mill for 12 weeks. Receives: 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. Receives: Dietary Supplement: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Colonic transit time during 2 weeks
The number of retained radiopaque markers on a Day 4 plain abdominal film
Measured: 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
Measured: At the 4th weeks after the start of the study
Secondary outcomes (12)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: At the 2nd weeks after the start of the study
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.
Measured: At the 2nd weeks after the start of the study
Change in Interferon-1β during 4 weeks
concentration (U/ml)
Measured: At 4th weeks after the start of the study
Change in Tumor necrosis factor-α during 4 weeks
concentration (pg/ml)
Measured: At 4th weeks after the start of the study
Change in Constipation Visual Analogue Scale during 4 weeks
The minimum score was 0, the maximum score was 100, and higher scores
Measured: 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
Frequency of Bristol stool Form scale types 3 and 4 per week
Measured: At the 4th weeks after the start of the study
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.
Measured: At the 4th weeks after the start of the study
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.
Measured: At the 4th weeks after the start of the study
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.
Measured: At the 4th weeks after the start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start1 Jul 2022
- Primary completion30 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang Yeoup Lee, Pusan National University Yangsan Hospital
- Investigators
- Sang Yeoup Lee, MD, PhD, Principal investigator, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05548842
- Sponsor's protocol ID
- 02-2022-010
- Status last verified
- Apr 2024
- First submitted
- 14 Sep 2022
- Last updated
- 9 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05548842
- Acronym / sponsor ID
- 02-2022-010
- Conditions
- Chronic Constipation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined group | Experimental | Dietary Supplement: The combined seed extracts of Cassia obtusifolia Linne and Foeniculum vulgare MillThis group takes the combined seed extracts of Cassia obtusifolia Linne and Foeniculum vulgare Mill for 12 weeks. |
| Placebo group | Placebo comparator | Dietary Supplement: Placebo groupThis group takes placebo for 12 weeks. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The combined seed extracts of Cassia obtusifolia Linne and Foeniculum vulgare MillThe combined seed extracts of Cassia obtusifolia Linne and Foeniculum vulgare Mill 1,000 mg/day for 4 weeks | Dietary supplement | Combined group |
| Placebo groupPlacebo 1,000 mg/day for 4 weeks | Dietary supplement | Placebo group |
Primary outcome
Change in Colonic transit time during 2 weeks
Time frame: At the 2nd weeks after the start of the study
The number of retained radiopaque markers on a Day 4 plain abdominal film
Change in Colonic transit time during 4 weeks
Time frame: At the 4th weeks after the start of the study
The number of retained radiopaque markers on a Day 4 plain abdominal film
12 secondary outcomes
Change in Constipation Visual Analogue Scale during 2 weeks
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
Time frame: At the 2nd weeks after the start of the study
Change in Visual Analogue Scale for Irritable Bowel Syndrome during 2 weeks
Time frame: At the 2nd weeks after the start of the study
Change in Irritable Bowel Syndrome severity scoring system during 2 weeks
Time frame: At the 2nd weeks after the start of the study
Change in Irritable Bowel Syndrome Quality of Life instrument during 2 weeks
Time frame: At the 2nd weeks after the start of the study
Change in Interferon-1β during 4 weeks
Time frame: At 4th weeks after the start of the study
Change in Tumor necrosis factor-α during 4 weeks
Time frame: At 4th weeks after the start of the study
Change in Constipation Visual Analogue Scale during 4 weeks
Time frame: 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
Time frame: At the 4th weeks after the start of the study
Change in Visual Analogue Scale for Irritable Bowel Syndrome during 4 weeks
Time frame: At the 4th weeks after the start of the study
Change in Irritable Bowel Syndrome severity scoring system during 4 weeks
Time frame: At the 4th weeks after the start of the study
Change in Irritable Bowel Syndrome Quality of Life instrument during 4 weeks
Time frame: At the 4th weeks after the start of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang Yeoup Lee, MD, PhD principal investigator
Pusan National University Yangsan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The combined seed extracts of Cassia obtusifolia Linne and Foeniculum vulgare Mill in people with Chronic Constipation, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Colonic transit time during 2 weeks (time frame: At the 2nd weeks after the start of the study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.