Functional constipation
Conditions
Interventions
Experimental Group:Congrong Runtong Oral Liquid
placebo group:Congrong Runtong Oral Liquid simulant
Sponsors
Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical 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 (developed based on the "Rome IV Diagnostic Criteria for Functional Gastrointestinal Disorders" published by the Rome Commission in 2016); 2. Meets the diagnostic criteria for yang deficiency constipation in traditional Chinese medicine (developed based on the "Technical Guidelines for Clinical Research of New Chinese Herbal Drugs for the Treatment of Chronic Constipation (2020)" and the "Expert Consensus on the Diagnosis and Treatment of Constipation in Traditional Chinese Medicine (2017)"); 3. Aged between 18 and 70 years (inclusive); 4. Has colonoscopy results, with the diagnosis being no abnormalities or non-adenomatous colonic polyps (size not exceeding 0.5 cm, number not exceeding 3), or at least one month after polypectomy, with pathology confirming non-high-grade intraepithelial neoplasia, based on colonoscopy results from a tertiary Class A hospital within the past 12 months; 5. Fewer than 3 complete spontaneous bowel movements (CSBM) in the last week of the run-in period; 6. Voluntarily participates in the trial and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with constipation caused by intestinal narrowing due to organic lesions of the rectum and colon (such as tumors, inflammatory bowel disease, anal fissures, intestinal adhesions, intestinal tuberculosis, etc.); 2. Patients with constipation caused by other systemic organic diseases, such as congenital megacolon, neurological disorders (such as autonomic neuropathy, cerebrovascular diseases, etc.), mental disorders, metabolic and endocrine disorders [such as hypothyroidism, diabetes (fasting blood glucose > 8.6 mmol/L or with diabetic complications), etc.], muscle diseases (such as amyloidosis, dermatomyositis, etc.); 3. Patients for whom drug-related constipation cannot be ruled out, as determined by the investigator; 4. Patients with alarm symptoms, and whose colonoscopy results from the past three months cannot exclude malignant lesions, as determined by the investigator; 5. Patients with ALT or AST = 1.5 times the upper limit of normal, or Scr > upper limit of normal; 6. Patients allergic to the components of Cistanches Herba Oral Liquid or bisacodyl; 7. Pregnant or women planning to become pregnant, or breastfeeding women; 8. Patients who have participated in other clinical trials within the past three months; 9. Patients for whom the investigator considers it inappropriate to participate in this trial for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Spontaneous Bowel Movement (CSBM) Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of spontaneous bowel movements (SBM) compared to baseline.;Response Rate of CSBM;Bowel Straining Severity Score (Using a Likert Scale) Compared to Baseline;Proportion of participants with SBM fecal consistency scores ranging from 1 to 7.;The change in Traditional Chinese Medicine (TCM) symptom scores from baseline.;Change in scores of the Patient Assessment of Constipation-Quality of Life (PAC-QOL) compared to baseline.;The proportion of participants using rescue medication (bisacodyl enteric-coated tablets), the total number of tablets used;The frequency of CSBM, the frequency of SBM, stool consistency score, straining during defecation score, compared to the last week of the 8-week treatment period.; | — |
Countries
China
Contacts
Public ContactZhang Shengsheng
Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Outcome results
None listed