Overview

Congrong Runtong Oral Liquid in the Treatment of Functional Constipation (Yang-deficiency Type)

Status:
Not yet recruiting
Trial end date:
2025-06-30
Target enrollment:
0
Participant gender:
All
Summary
Using a placebo as a control, this study aims to preliminarily evaluate the clinical efficacy of Congrong Runtong oral liquid for the treatment of functional constipation (Yang-deficiency type), explore the optimal dosage of Congrong Runtong oral liquid for functional constipation (Yang-deficiency type) to provide a basis for dosage selection in Phase III clinical trials, and observe the safety of clinical use of Congrong Runtong oral liquid.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Beijing Hospital of Traditional Chinese Medicine
Criteria
Inclusion Criteria:

1. Meets the Rome IV diagnostic criteria for functional constipation;

2. Meets the TCM diagnostic criteria for Yang-deficiency type constipation;

3. Aged between 18 and 70 years (inclusive);

4. Has undergone colonoscopy and has been diagnosed with either no abnormalities or
non-adenomatous polyps (size not exceeding 0.5 cm, no more than 3) or has undergone
polypectomy for more than 1 month and the pathological examination confirms no
high-grade intraepithelial neoplasia within 12 months of colonoscopy examination in a
tertiary grade A hospital

5. Less than 3 complete spontaneous bowel movements per week during the 2-week run-in
period;

6. Voluntarily participates in the trial and signs an informed consent form.

Exclusion Criteria:

1. Patients with constipation caused by organic lesions of the rectum or colon (such as
tumors, inflammatory bowel disease, anal fissure, intestinal adhesions, intestinal
tuberculosis) leading to intestinal stenosis;

2. Patients with constipation caused by other systemic organic diseases, such as
congenital megacolon, neurological disorders (such as autonomic neuropathy,
cerebrovascular disease, etc.), mental disorders, metabolic endocrine disorders (such
as hypothyroidism, diabetes mellitus with fasting blood glucose > 8.6mmol/L or with
complications), muscular diseases (such as amyloidosis, dermatomyositis), etc.;

3. Patients whose drug-induced constipation cannot be ruled out by the investigators;

4. Patients with alarm signs judged by the investigator and unable to exclude malignant
lesions by colonoscopy in the past three months;

5. ALT or AST ≥ 1.5 times the upper limit of the normal value, or Scr > upper limit of
the normal value;

6. Patients allergic to the composition of the ingredients of the Cenruong Runtong oral
solution or bisacodyl;

7. Pregnant or breastfeeding women, or women planning to become pregnant;

8. Patients who have participated in other clinical trials in the past 3 months;

9. Other situations judged by the investigator as inappropriate for participation in this
trial.