This trial is a randomized, double-blind, placebo-controlled parallel-group, multicenter Phase III clinical trial. It is to evaluate the efficacy and safety of Xuanhuang Runtong Tablets in subjects with constipation (Yin-deficiency type) after 4 weeks of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
300
A synthetic tablet is mainly composed of Radix Rehmanniae, Radix Scrophulariae, Radix Angelicae Sinensis, Semen Persicae, Herba Cistanches, Fructus Cannabis, Semen Cassiae, Fructus Aurantii Immaturus and Aloe.
Xuanhuang Runtong Tablet Simulator
Complete Spontaneous Bowel Movement (CSBM) response rate after 4 weeks of treatment.
CSBM: The number of spontaneous bowel movements with a complete sense of evacuation without taking rescue laxatives or with the assistance of manipulation. (Taking rescue medications within 24 hours before defecation is not counted as CSBM). Weekly response: If a patient has at least 3 CSBMs in a week and an increase of at least 1 CSBM compared to the baseline, it is considered a weekly response. CSBM response: The patient meets the CSBM weekly response for at least 50% of the weeks during drug treatment (e.g., 3 out of 4 weeks). Overall CSBM response rate = Number of CSBM responders / Total number of observed patients × 100%.
Time frame: Examination will be performed 4 weeks of treatment.
Complete Spontaneous Bowel Movement (CSBM) response rate after 2 weeks of treatment.
Overall CSBM response rate = Number of CSBM responders / Total number of observed patients × 100%.
Time frame: Examination will be performed 2 weeks of treatment.
The change in the number of bowel movements (BM) at the last week compared to baseline
The patient recorded the number of BMs every day using a diary card.
Time frame: Evaluation will be performed at baseline and 4 weeks of treatment.
The change in the number of spontaneous bowel movements (SBM) at the last week compared to baseline .
The patient recorded the number of SBMs every day using a diary card.
Time frame: Evaluation will be performed at baseline and 4 weeks of treatment.
The change in the fecal characteristics score (using the Bristol Stool Form Scale) at the last week compared to baseline.
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.
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Time frame: Evaluation will be performed at baseline and 4 weeks of treatment.
The change in the degree of difficulty in passing stools score (using the Likert scale) at the last week compared to baseline.
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 4 weeks of treatment.
The proportion of subjects with fecal characteristics of type 4 or 5 in the last spontaneous bowel movement (SBM) during the treatment period.
Calculate the proportion of subjects whose fecal consistency of the last spontaneous bowel movement (SBM) during the treatment period is Type 4 or Type 5 among all subjects.
Time frame: Evaluation will be performed at baseline and 4 weeks of treatment.
The changes inTraditional Chinese Medicine (TCM) syndrome scores at the last week compared to baseline.
The TCM syndrome score of constipation consists of 8 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 4 weeks of treatment.
Efficacy of TCM syndromes
The efficacy index of TCM syndromes : (pre - treatment score - post - treatment score) / pre - treatment score × 100%. It is divided into four levels: clinical recovery, marked effectiveness, effectiveness, and ineffectiveness.
Time frame: Examination will be performed at baseline and 4 weeks of treatment.
The disappearance rate of single symptoms of TCM syndromes
The disappearance rate of single symptoms of TCM syndromes refers to the percentage of the number of cases with a single - symptom score of 0 in each single symptom among the total number of cases (when calculating the denominator, subjects with a single - symptom score of 0 at baseline need to be excluded).
Time frame: Examination will be performed at baseline and 4 weeks of treatment.
The use of rescue medication.
Calculate the total number of rescue medication doses taken during the treatment period.
Time frame: Examination will be performed 4 weeks of treatment.
Changes in the Patient Assessment of Constipation Quality of Life (PAC-QOL) score compared to baseline at 4 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
Time frame: Examination will be performed at baseline and 4 weeks of treatment.