Constipation
Conditions
Interventions
Test group:1) Intervention for 2 weeks (Weeks 1-2): Take 4 capsules daily (twice a day, 2 capsules each time, once after breakfast, and once after dinner or before bedtime), with a washout period of 1
2) Intervention for 3 weeks (Weeks 4-6): Take 3 capsules daily, all taken after dinner or before bedtime, with a washout period of 1 week (Week 7)
3) Intervention for 3 weeks (Weeks 8-10): Take 2 capsules daily, all taken after dinner or before bedtime.
Sponsors
Xiangya Hospital Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Meets the Rome IV diagnostic criteria for functional constipation; 2) Aged 18-70 years old (inclusive), irrespective of gender; 3) During the screening period, the average number of spontaneous bowel movements per week was = 1 time and < 3 times, and at least 25% of the defecations were felt to be difficult or the stools were in a lumpy/ hard state (Bristol Stool Form Scale types 1-2); 4) Voluntarily signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Secondary constipation (caused by hypothyroidism, diabetes, neurological disorders, drugs, etc.); 2) Diagnosed with constipation-predominant irritable bowel syndrome(IBS-C) or diarrhea-predominant irritable bowel syndrome(IBS-D); 3) Have a history of major gastrointestinal surgeries (excluding appendectomy and herniorrhaphy); 4) Have severe functional disorders of important organs such as the heart, liver, and kidneys; suffer from renal insufficiency, nephritis, hypertensive nephropathy, hyperkalemia, hypermagnesemia, hypernatremia, etc.; 5) Have a history of allergy to the investigational product or its analogues; 6) Pregnant or lactating women, or individuals planning pregnancy without using effective contraception; 7) Have used drugs affecting gastrointestinal motility, probiotics, laxatives, or participated in other clinical trials within 1 month prior to screening; 8) Have severe uncontrolled mental disorders, a history of drug abuse, or the investigator judges that the compliance may be poor; 9) Other conditions deemed by clinical assessment as unsuitable for trial participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Diary of Bowel Movements (including Bristol Stool Form Scale);Stool Constipation Symptom Assessment Scale;The Quality of Life Scale for Constipation Patients;Intestinal flora;Colonoscopy;Dependency assessment; | — |
Countries
China
Contacts
Public ContactPeng Jie
Xiangya Hospital Central South University
Outcome results
None listed