Clinical trial NCT05548842: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Constipation
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Colonic transit time during 2 weeks
timeFrame: At the 2nd weeks after the start of the study
measure: Change in Colonic transit time during 4 weeks
timeFrame: At the 4th weeks after the start of the study
Secondary outcomes:
measure: Change in Constipation Visual Analogue Scale during 2 weeks
timeFrame: At the 2nd weeks after the start of the study
measure: Change in Bristol stool Form scale type 3 and 4 (frequency per week) during 2 weeks
timeFrame: At the 2nd weeks after the start of the study
measure: Change in Visual Analogue Scale for Irritable Bowel Syndrome during 2 weeks
timeFrame: At the 2nd weeks after the start of the study
measure: Change in Irritable Bowel Syndrome severity scoring system during 2 weeks
timeFrame: At the 2nd weeks after the start of the study
measure: Change in Irritable Bowel Syndrome Quality of Life instrument during 2 weeks
timeFrame: At the 2nd weeks after the start of the study
measure: Change in Interferon-1β during 4 weeks
timeFrame: At 4th weeks after the start of the study
measure: Change in Tumor necrosis factor-α during 4 weeks
timeFrame: At 4th weeks after the start of the study
measure: Change in Constipation Visual Analogue Scale during 4 weeks
timeFrame: At the 4th weeks after the start of the study
measure: Change in Bristol stool Form scale type 3 and 4 (frequency per week) during 4 weeks
timeFrame: At the 4th weeks after the start of the study
measure: Change in Visual Analogue Scale for Irritable Bowel Syndrome during 4 weeks
timeFrame: At the 4th weeks after the start of the study
measure: Change in Irritable Bowel Syndrome severity scoring system during 4 weeks
timeFrame: At the 4th weeks after the start of the study
measure: Change in Irritable Bowel Syndrome Quality of Life instrument during 4 weeks
timeFrame: At the 4th weeks after the start of the study
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyeungsangnam-do
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: Sang Yeoup Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: