Back to resultsCongrong Runtong Oral Liquid in the Treatment of Functional Constipation (Yang-deficiency Type)
Primary Purpose
Functional Constipation
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Congrong Runtong oral liquid
Placental Congrong Runtong oral liquid
Sponsored by
About this trial
This is an interventional treatment trial for Functional Constipation
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Congrong Runtong oral liquid high-dose group
Congrong Runtong oral liquid low-dose group
Placebo group
Arm Description
Congrong Runtong oral liquid, 2 bottles (1g herb content per bottle) per dose, three times a day
Congrong Runtong oral liquid, 2 bottles (0.5g herb content per bottle) per dose, three times a day
Congrong Runtong oral liquid, 2 bottles (0g herb content per bottle) per dose, three times a day
Outcomes
Primary Outcome Measures
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%"
Secondary Outcome Measures
The occurrence of CSBM within the first 24 hours of starting treatment
Calculate the number of CSBM during the first 24 hours of treatment
Changes in the number of bowel movements (BM)compared to baseline at 2, 4, 6, and 8 weeks
The patient recorded the number of BMs every day using a diary card, and the weekly number of BMs was the total of the seven days
Changes in the number of spontaneous bowel movements (SBM)compared to baseline at 2, 4, 6, and 8 weeks
The patient recorded the number of SBMs every day using a diary card, and the weekly number of SBMs was the total of the seven days
Changes in the fecal characteristics score (using the Bristol Stool Form Scale) compared to baseline at 2, 4, 6, and 8 weeks
Bristol Stool Form Scale： Type 1 Separate hard lumps, like nuts. Type 2 Sausage-shaped but lumpy. Type 3 Like a sausage or snake but with cracks on its surface. Type 4 Like a sausage or snake, smooth and soft. Type 5 Soft blobs with clear-cut edges. Type 6 Fluffy pieces with ragged edges, a mushy stool.
Type 7 Watery, no solid pieces. The 1-7 types correspond to scores of 1-7 respectively.
Changes in the degree of difficulty in passing stools score (using the Likert scale) compared to baseline at 2, 4, 6, and 8 weeks
The Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire uses a Likert scale grading system for rating the severity of constipation symptoms, which is divided into five levels of severity: 0, 1, 2, 3, and 4.
The average number of CSBMs per week
The average number of CSBMs per week is calculated by dividing the total number of CSBMs during the observation period by the number of observation weeks (8 weeks)
The average number of SBMs per week
The average number of SBMs per week is calculated by dividing the total number of SBMs during the observation period by the number of observation weeks (8 weeks)
The average fecal characteristic score per week (using the Bristol Stool Chart)
The stool consistency score for each week is calculated by dividing the sum of all stool consistency scores for that week by the total number of bowel movements during that week.The average stool consistency score per week is calculated by dividing the sum of all weekly stool consistency scores by the number of observation weeks (8 weeks).
The use of rescue medication
Calculate the total number of rescue medication doses taken during the treatment period
The changes in TCM syndrome scores compared to baseline at 4 and 8 weeks of treatment
The TCM syndrome score of functional constipation consists of 5 questions, and the total scores are ranging from 0 to 24 with higher scores indicating more severe disease.
Changes in the Patient Assessment of Constipation Quality of Life (PAC-QOL) score compared to baseline at 4 and 8 weeks of treatment
Calculate the total PAC-QOL score and the change in scores for the physiological, psychosocial, worries, and satisfaction domains compared to baseline
Full Information
NCT ID
NCT05803161
First Posted
March 26, 2023
Last Updated
March 26, 2023
Sponsor
Beijing Hospital of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05803161
Brief Title
Congrong Runtong Oral Liquid in the Treatment of Functional Constipation (Yang-deficiency Type)
Official Title
A Randomized, Double-blind, Dose-exploration, Parallel-controlled, Multicenter Phase II Clinical Study of Congrong Runtong Oral Liquid in the Treatment of Functional Constipation (Yang-deficiency Type)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Hospital of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Constipation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Congrong Runtong oral liquid high-dose group
Arm Type
Experimental
Arm Description
Congrong Runtong oral liquid, 2 bottles (1g herb content per bottle) per dose, three times a day
Arm Title
Congrong Runtong oral liquid low-dose group
Arm Type
Experimental
Arm Description
Congrong Runtong oral liquid, 2 bottles (0.5g herb content per bottle) per dose, three times a day
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Congrong Runtong oral liquid, 2 bottles (0g herb content per bottle) per dose, three times a day
Intervention Type
Drug
Intervention Name(s)
Congrong Runtong oral liquid
Intervention Description
Congrong Runtong oral liquid：component "total glycosides of Cistanche" extracted and refined from the traditional Chinese medicine Cistanche deserticola
Intervention Type
Drug
Intervention Name(s)
Placental Congrong Runtong oral liquid
Intervention Description
Placental Congrong Runtong oral liquid
Primary Outcome Measure Information:
Title
Complete Spontaneous Bowel Movement (CSBM) response rate within 8 weeks of treatment
Description
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%"
Time Frame
Examination will be performed after 8 weeks of treatment.
Secondary Outcome Measure Information:
Title
The occurrence of CSBM within the first 24 hours of starting treatment
Description
Calculate the number of CSBM during the first 24 hours of treatment
Time Frame
Evaluation will be performed after 24 hours of treatment.
Title
Changes in the number of bowel movements (BM)compared to baseline at 2, 4, 6, and 8 weeks
Description
The patient recorded the number of BMs every day using a diary card, and the weekly number of BMs was the total of the seven days
Time Frame
Evaluation will be performed at baseline and after2，4，6，8 weeks of treatment.
Title
Changes in the number of spontaneous bowel movements (SBM)compared to baseline at 2, 4, 6, and 8 weeks
Description
The patient recorded the number of SBMs every day using a diary card, and the weekly number of SBMs was the total of the seven days
Time Frame
Evaluation will be performed at baseline and after2，4，6，8 weeks of treatment.
Title
Changes in the fecal characteristics score (using the Bristol Stool Form Scale) compared to baseline at 2, 4, 6, and 8 weeks
Description
Bristol Stool Form Scale： Type 1 Separate hard lumps, like nuts. Type 2 Sausage-shaped but lumpy. Type 3 Like a sausage or snake but with cracks on its surface. Type 4 Like a sausage or snake, smooth and soft. Type 5 Soft blobs with clear-cut edges. Type 6 Fluffy pieces with ragged edges, a mushy stool.
Type 7 Watery, no solid pieces. The 1-7 types correspond to scores of 1-7 respectively.
Time Frame
Evaluation will be performed at baseline and after2，4，6，8 weeks of treatment.
Title
Changes in the degree of difficulty in passing stools score (using the Likert scale) compared to baseline at 2, 4, 6, and 8 weeks
Description
The Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire uses a Likert scale grading system for rating the severity of constipation symptoms, which is divided into five levels of severity: 0, 1, 2, 3, and 4.
Time Frame
Evaluation will be performed at baseline and after2，4，6，8 weeks of treatment.
Title
The average number of CSBMs per week
Description
The average number of CSBMs per week is calculated by dividing the total number of CSBMs during the observation period by the number of observation weeks (8 weeks)
Time Frame
Examination will be performed after 8 weeks of treatment.
Title
The average number of SBMs per week
Description
The average number of SBMs per week is calculated by dividing the total number of SBMs during the observation period by the number of observation weeks (8 weeks)
Time Frame
Examination will be performed after 8 weeks of treatment.
Title
The average fecal characteristic score per week (using the Bristol Stool Chart)
Description
The stool consistency score for each week is calculated by dividing the sum of all stool consistency scores for that week by the total number of bowel movements during that week.The average stool consistency score per week is calculated by dividing the sum of all weekly stool consistency scores by the number of observation weeks (8 weeks).
Time Frame
Examination will be performed after 8 weeks of treatment.
Title
The use of rescue medication
Description
Calculate the total number of rescue medication doses taken during the treatment period
Time Frame
Examination will be performed after 8 weeks of treatment.
Title
The changes in TCM syndrome scores compared to baseline at 4 and 8 weeks of treatment
Description
The TCM syndrome score of functional constipation consists of 5 questions, and the total scores are ranging from 0 to 24 with higher scores indicating more severe disease.
Time Frame
Examination will be performed at baseline and after 4,8 weeks of treatment.
Title
Changes in the Patient Assessment of Constipation Quality of Life (PAC-QOL) score compared to baseline at 4 and 8 weeks of treatment
Description
Calculate the total PAC-QOL score and the change in scores for the physiological, psychosocial, worries, and satisfaction domains compared to baseline
Time Frame
Examination will be performed at baseline and after4，8 weeks of treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Congrong Runtong Oral Liquid in the Treatment of Functional Constipation (Yang-deficiency Type)
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