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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xuanhuang Runtong Tablet group | Experimental | Xuanhuang Runtong Tablet, 4 tablets (1.84 g herb per tablet) per dose, three times a day |
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| Placebo group | Placebo Comparator | Xuanhuang Runtong Tablet Simulator, 4 tablets (0 g herb content per bottle) per dose, three times a day |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xuanhuang Runtong Tablet | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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%. | Examination will be performed 4 weeks of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| 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%. | Examination will be performed 2 weeks of treatment. |
| The change in the number of bowel movements (BM) at the last week compared to baseline |
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Inclusion Criteria:
Subjects must meet all of the following inclusion criteria to enter the run-in period:
At the end of the run-in period, subjects must meet all of the following criteria to enter the treatment period:
Exclusion Criteria:
Subjects with any of the following items cannot enter the run-in period/treatment period:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lu Qing Zhao, Doctor | Contact | 01087906580 | zhaoluqing@bjzhongyi.com |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Xuanhuang Runtong Tablet Simulator | Drug | Xuanhuang Runtong Tablet Simulator |
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The patient recorded the number of BMs every day using a diary card. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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. | 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 | Examination will be performed at baseline and 4 weeks of treatment. |