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The purpose of this study are as follows: 1) To evaluate the efficacy and safety of Qizhi Weitong granules in the treatment of diarrhea-type irritable bowel syndrome (IBS-D);2) To explore the dosage of Qizhi Weitong Granulesin treatment of IBS-D.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Qizhi Weitong granules high-dose group | Experimental | interventions:Qizhi Weitong granules Specification: 5.0g/bag,the drug content is equivalent to 2 bags of Qizhi Weitong granules (2.5g/ bag commercially available). |
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| Qizhi Weitong granules low-dose group | Experimental | interventions:Qizhi Weitong granules Specification: 5.0g/bag,the drug content is equivalent to 1 bag of Qizhi Weitong granules (2.5g/ bag commercially available). |
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| The control group | Placebo Comparator | interventions:Qizhi Weitong granules placebo Specification: 5.0g/bag,Does not contain effective crude drug ingredients. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Qizhi weitong granules(High) | Drug | take orally before meals, 1 bag each time, 3 times a day. |
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| Measure | Description | Time Frame |
|---|---|---|
| Abdominal pain intensity | the most severe abdominal pain score in the past 24 hours, with a weekly mean decrease of at least 30% from baseline; | Recorded daily by patients from baseline to day56 |
| Improvement of stool characteristics | Record daily by symptom diary card.Stools were recorded according to Bristol Stool Chart. | Recorded daily by patients from baseline to day56 |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of abdominal pain | Number of abdominal pain | Recorded daily by patients from baseline to day56 |
| IBS symptom severity scale(IBS-SSS) | The IBS symptom severity questionnaire consists of four questions on a 100-point scale, with the highest score being 100 and the lowest being 0. The higher the score, the more severe the symptoms. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xudong Tang, professor | Contact | +86 10-62835001 | txdly@sina.com.cn |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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The study was divided into three groups: Qizhi Weitong granule high-dose group, Qizhi Weitong granule low-dose group and placebo group
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| Qizhi weitong granules(Low) | Drug | take orally before meals, 1 bag each time, 3 times a day. |
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| Placebo | Drug | take orally before meals, 1 bag each time, 3 times a day. |
|
| Baseline and days 14,28,56 |
| IBS Quality of Life Scale(IBS-QOL) | The IBS Quality of Life scale has 34 questions, and adopts a five-level scoring system, with the highest score of 4 points and the lowest score of 0 points. The higher the score, the more serious it is. | Baseline and days 14,28,56 |
| Self-rating Anxiety Scale(SAS) | There are 20 questions in the self-rating anxiety scale, which is graded at four levels, with the highest score being 4 and the lowest score being 1. The higher the score is, the more serious it is. | baseline and day56 |
| Self-rating Depression Scale(SDS) | There are 20 questions in the Self-rating Depression Scale, which is graded at four levels, with the highest score being 4 and the lowest score being 1. The higher the score is, the more serious it is. | baseline and day56 |
| Emergency drug use | Subjects may take Piaverium bromide tablets 3-4 tablets per day if they feel unbearable abdominal pain, and increase to 6 tablets per day if necessary. | Emergence,baseline and days 14,28,56 |
| D004066 | Digestive System Diseases |