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

NCT05803161 | Completed Phase 2

• 1 other identifier: KANION-CRRT-2022
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Functional Constipation

Outcome Measures

Primary Outcomes (1)

• Complete Spontaneous Bowel Movement (CSBM) response rate within 8 weeks of treatment

  CSBM response: the patient meets the CSBM weekly response at least 50% of the time during the weeks of drug treatment (e.g., 4/8 weeks). Weekly response: The patient has at least 3 CSBMs per week and has an increase of at least one CSBM compared to baseline, which is considered a weekly response. Overall CSBM response rate = CSBM response number / total observed number of people × 100%"

  Examination will be performed after 8 weeks of treatment.

Secondary Outcomes (11)

• The occurrence of CSBM within the first 24 hours of starting treatment

  Evaluation will be performed after 24 hours of treatment.

• Changes in the number of bowel movements (BM)compared to baseline at 2, 4, 6, and 8 weeks

  Evaluation will be performed at baseline and after2，4，6，8 weeks of treatment.

• Changes in the number of spontaneous bowel movements (SBM)compared to baseline at 2, 4, 6, and 8 weeks

  Evaluation will be performed at baseline and after2，4，6，8 weeks of treatment.

• Changes in the fecal characteristics score (using the Bristol Stool Form Scale) compared to baseline at 2, 4, 6, and 8 weeks

  Evaluation will be performed at baseline and after2，4，6，8 weeks of treatment.

• Changes in the degree of difficulty in passing stools score (using the Likert scale) compared to baseline at 2, 4, 6, and 8 weeks

  Evaluation will be performed at baseline and after2，4，6，8 weeks of treatment.

Study Arms (3)

Congrong Runtong oral liquid high-dose group

EXPERIMENTAL

Congrong Runtong oral liquid, 2 bottles (1g herb content per bottle) per dose, three times a day

Drug: Congrong Runtong oral liquid

Congrong Runtong oral liquid low-dose group

EXPERIMENTAL

Congrong Runtong oral liquid, 2 bottles (0.5g herb content per bottle) per dose, three times a day

Drug: Congrong Runtong oral liquid

Placebo group

PLACEBO COMPARATOR

Congrong Runtong oral liquid, 2 bottles (0g herb content per bottle) per dose, three times a day

Drug: Placental Congrong Runtong oral liquid

Interventions

Congrong Runtong oral liquid DRUG

Congrong Runtong oral liquid：component "total glycosides of Cistanche" extracted and refined from the traditional Chinese medicine Cistanche deserticola

Congrong Runtong oral liquid high-dose group; Congrong Runtong oral liquid low-dose group

Placental Congrong Runtong oral liquid DRUG

Placental Congrong Runtong oral liquid

Placebo group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets the Rome IV diagnostic criteria for functional constipation;
• Meets the TCM diagnostic criteria for Yang-deficiency type constipation;
• Aged between 18 and 70 years (inclusive);
• 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
• Less than 3 complete spontaneous bowel movements per week during the 2-week run-in period;
• Voluntarily participates in the trial and signs an informed consent form.

You may not qualify if:

• 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;
• 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.;
• Patients whose drug-induced constipation cannot be ruled out by the investigators；
• Patients with alarm signs judged by the investigator and unable to exclude malignant lesions by colonoscopy in the past three months;
• ALT or AST ≥ 1.5 times the upper limit of the normal value, or Scr \> upper limit of the normal value;
• Patients allergic to the composition of the ingredients of the Cenruong Runtong oral solution or bisacodyl;
• Pregnant or breastfeeding women, or women planning to become pregnant;
• Patients who have participated in other clinical trials in the past 3 months;
• Other situations judged by the investigator as inappropriate for participation in this trial.

Sponsors & Collaborators

• Beijing Hospital of Traditional Chinese Medicine: lead

Study Sites (1)

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University

Beijing, Dongcheng, 100010, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 26, 2023
• First Posted: April 7, 2023
• Study Start: March 29, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: October 28, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)