None listed
Conditions
Interventions
Dietary Supplement : All participants in this clinical trial will consume the test food with water. The total intake period for both the test and control foods will be 28 days per participant.
Both th
Sponsors
Cheonan Korean Medicine Hospital of Daejeon University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female adults aged between 19 and 75 years. 2. Subjects diagnosed with functional constipation according to the Rome IV criteria: -Symptoms began at least 6 months prior to screening and have been present during the last 3 months, with at least two or more of the following: 1) Straining during more than 25% of defecations 2) Lumpy or hard stools in more than 25% of defecations 3) Sensation of incomplete evacuation in more than 25% of defecations 4) Sensation of anorectal obstruction/blockage in more than 25% of defecations 5) Manual maneuvers to facilitate defecation in more than 25% of defecations 6) Fewer than three spontaneous bowel movements per week 3. Subjects capable of performing normal physical activity and who voluntarily provide written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Subjects who have taken physician-prescribed laxatives within 1 month prior to the screening visit. 2. Subjects who have taken probiotic preparations within 1 month prior to the screening visit. 3. Subjects with inflammatory bowel disease or malignant tumors (confirmed by colonoscopy results within the past 4 years). 4. Subjects with secondary constipation induced by medications or underlying diseases. 5. Subjects with uncontrolled hypertension (blood pressure =160/100 mmHg). 6. Subjects with uncontrolled diabetes mellitus (fasting blood glucose =180 mg/dL). 7. Subjects with uncontrolled hyperthyroidism or hypothyroidism. 8. Subjects with serum creatinine levels =2.5 times the upper limit of normal (ULN) at the study site. 9. Subjects with AST (GOT) or ALT (GPT) levels =3 times the ULN at the study site. 10. Subjects with severe gastrointestinal symptoms such as heartburn or dyspepsia. 11. Subjects who have participated in another clinical trial and received an intervention within 1 month prior to the study, or who plan to participate in another clinical trial during the study period. 12. Pregnant or breastfeeding women. 13. Subjects with psychiatric disorders such as severe depression, schizophrenia, or drug dependence. 14. Subjects with alcohol abuse. 15. Subjects with known allergy or hypersensitivity to the investigational product. 16. Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in constipation symptoms (Visual Analogue Scale) | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of types 3 and 4 over one week based on the Bristol stool form scale questionnaire;Irritable Bowel Syndrome Symptom severity scale(IBS-SSS);Quality of Life (IBS-QOL);defecation diary (dececation frequency, average time per defecation);Defecation habit questionnaire (sensation of incomplete evacuation, sensation of anorectal obstruction, abdominal discomfort and pain, overall satisfaction with defecation) | — |
Countries
Korea, Republic of
Contacts
Public ContactJae Hui Kang
Cheonan Korean Medicine Hospital of Daejeon University
Outcome results
None listed