Functional Constipation With Yang-Deficiency Pattern
Conditions
Interventions
Low-Dose group:Low-Dose SCD-2101 15g/day
Medium-Dose group:Medium-Dose SCD-2101 22.5g/day
High-Dose group:Medium-Dose SCD-2101 30g/day
SCD-2101 group:Final dose to be selected based on Phase 1 results, twice daily for 8 weeks
Placebo group:Matching SCD-2101,twice daily for 8 weeks
Sponsors
Guangdong Provincial Hospital of Integrated Traditional Chinese and Western Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1 Adults at least 18 years 2 Meet Rome IV criteria for functional constipation 3 Meet TCM 2017 Consensus criteria for Yang-deficiency constipation 4 CSBM at most 2 per week based on 2 weeks diary 5 Able to understand written or spoken Chinese instructions 6 Able to complete diaries independently 7 Provided written informed consent
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria will be excluded: (1) Secondary constipation (constipation caused by medication or other diseases). (2) Currently using or requiring continued use of medications that may affect study outcomes (including but not limited to: antibiotics, hormonal drugs, analgesics, neurotransmitter-related drugs, intestinal flora modulators, etc.). (3) Clinically significant and untreated abnormalities detected by colonoscopy or sigmoidoscopy (applicable if any of the following conditions are met: (1) age 50 years or older; (2) family history of colorectal cancer or familial polyposis; (3) presence of alarm symptoms within the last 6 months (any of the following: unexplained weight loss of =10% within 3 months; hematochezia (not caused by hemorrhoids or anal fissures); unexplained fever; anemia)). (4) Allergy to any Chinese herbal medicine included in the study (Cistanche deserticola, Senna leaves, Astragalus membranaceus, Magnolia officinalis). (5) Clinically significant abnormalities in laboratory tests or imaging studies within the last 6 months. (6) History of abdominal surgery within the past year (except laparoscopic appendectomy). (7) Pregnant or breastfeeding women, or women planning to become pregnant within the next six months. (8) Individuals with psychiatric disorders or those requiring psychotropic medications. (9) Judged by the investigator as unsuitable for participation in the study due to psychological or physical reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall CSBM Responder Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Weekly CSBM responder rate;Change from Baseline in the Mean Weekly Frequency of Complete Spontaneous Bowel Movements (CSBMs);Title: Change from Baseline in the Mean Weekly Frequency of Spontaneous Bowel Movements (SBMs);Mean weekly stool consistency (Bristol Stool Form Scale);Change from Baseline in the Weekly Use Frequency of Rescue Medication;Change from Baseline in the PAC-SYM Questionnaire Score;Change from Baseline in the PAC-QoL Questionnaire Score;Change from Baseline in the TCM Pattern Score (Yang-deficiency constipation score);Lifestyle and Dietary Habits Questionnaire; | — |
Countries
China
Contacts
Public ContactZhong Wenying
Department of Gastroenterology,Guangdong Provincial Hospital of Integrated Traditional Chinese and Western Medicine(Nanhai District Hospital of Traditional Chinese Medicine of Foshan City
Outcome results
None listed