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The goal of this clinical trial is to test the efficacy and safety of the Chinese patent medicine Changyanning Tablet in the patients with Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D). The main questions it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Changyanning group | Experimental | Changyanning tablet: Each tablet weighs 0.42g and is taken orally, 4 tablets once and 3 times a day.The course of treatment was 8 weeks. |
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| Placebo group | Placebo Comparator | Changyanning tablet placebo: Each tablet weighs 0.42g and is taken orally, 4 tablets once and 3 times a day.The course of treatment was 8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Changyanning tablet | Drug | Changyanning Tablet is produced by Jiangxi Kang'enbei Traditional Chinese Medicine Co., Ltd，composed of Euphorbia humifusa, golden ear grass, camphor tree root, Elsholtzia splendens and maple leaves. It is mainly used for the treatment of acute and chronic intestinal diseases caused by various reasons. If the symptoms of the subject become worse and unbearable during the study period, it is allowed to add Pinaverium Bromide to the patient according to the specific situation. |
| Measure | Description | Time Frame |
|---|---|---|
| Weekly response rate of abdominal pain and diarrhea | The responder is defined when the following two points are met simultaneously： ① Abdominal pain intensity: the most severe abdominal pain score in the past 24 hours, the weekly average value is at least 30% lower than the baseline. To evaluate the intensity of abdominal pain, the patients were asked to grade "the most severe abdominal pain in the past 24 hours" every day by using the 0-10 numerical rating scale (NRS). ② Fecal traits: the number of days with type 6 or 7 stool traits in a week decreased by at least 50% from the baseline. Refer to Bristol Stool Traits Scale for evaluation of fecal traits. The response rate=(the number of the responders/the sample size of the group) x100%. | 8 weeks (after treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Weekly response rate of abdominal pain and diarrhea | The responder is defined when the following two points are met simultaneously： ① Abdominal pain intensity: the most severe abdominal pain score in the past 24 hours, the weekly average value is at least 30% lower than the baseline. To evaluate the intensity of abdominal pain, the patients were asked to grade "the most severe abdominal pain in the past 24 hours" every day by using the 0-10 numerical rating scale (NRS). ② Fecal traits: the number of days with type 6 or 7 stool traits in a week decreased by at least 50% from the baseline. Refer to Bristol Stool Traits Scale for evaluation of fecal traits. The response rate=(the number of the responders/the sample size of the group) x100%. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood routine test | This is a safety outcome. | baseline， 8weeks（after treatment） |
| C-reactive protein | This is a safety outcome. | baseline， 8weeks（after treatment） |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mei Han, Dr | Contact | +8613401131731 | hanmeizoujin@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Wei Wei, Pro | Wangjing Hospital of China Academy of Chinese Medical Sciences | Principal Investigator |
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| Changyanning tablet placebo | Other | Changyanning Tablet placebo is produced by Jiangxi Kang'enbei Traditional Chinese Medicine Co., Ltd. Changyanning Tablet placebo has the same appearance, smell, taste, specifications and packaging with Changyanning Tablet, but does not contain active pharmaceutical ingredients. If the symptoms of the subject become worse and unbearable during the study period, it is allowed to add Pinaverium Bromide to the patient according to the specific situation. |
|
| 2 weeks, 4 weeks, 6 weeks, 12 weeks |
| Weekly response rate of diarrhea | The responder is defined when the following two points are met simultaneously： ①Fecal traits: the number of days with type 6 or 7 stool traits in a week decreased by at least 50% from the baseline. Refer to Bristol Stool Traits Scale for evaluation of fecal traits. ②Abdominal pain intensity: the most severe abdominal pain score in the past 24 hours, the weekly average value is remained unchanged or improved from baseline. To evaluate the intensity of abdominal pain, the patients were asked to grade "the most severe abdominal pain in the past 24 hours" every day by using the 0-10 numerical rating scale (NRS). The response rate=(the number of the responders/the sample size of the group) x100%. | 2 weeks, 4 weeks, 6 weeks, 8 weeks，12 weeks |
| Weekly response rate of abdominal pain | The responder is defined when the following two points are met simultaneously： ①Abdominal pain intensity: the most severe abdominal pain score in the past 24 hours, the weekly average value is at least 30% lower than the baseline. To evaluate the intensity of abdominal pain, the patients were asked to grade "the most severe abdominal pain in the past 24 hours" every day by using the 0-10 numerical rating scale (NRS). ②Fecal traits: the number of days and frequency with type 6 or 7 stool traits in a week is remained unchanged or decreased from baseline. Refer to Bristol Stool Traits Scale for evaluation of fecal traits. The response rate=(the number of the responders/the sample size of the group) x100%. | 2 weeks, 4 weeks, 6 weeks, 8 weeks，12 weeks |
| IBS symptom severity scale（IBS-SSS）scores | There are five questions in the scale, each of which has a full score of 100 points and a total score of 500 points. The higher the total score, the more serious the patient's symptoms. | 2 weeks, 4 weeks, 6 weeks, 8 weeks，12 weeks |
| Stool frequency | Daily average number of spontaneous defecation in a week. | 2 weeks, 4 weeks, 6 weeks, 8 weeks，12 weeks |
| IBS quality of life (IBS-QOL) scores | The scale consists of 34 items, and each item is divided into five grades: asymptomatic, mild, moderate, overweight, and severe, with corresponding scores of 1-5. The higher the total score, the more serious the patient's symptoms. | 6 weeks, 8 weeks（after treatment），12 weeks（after follow-up） |
| Urine routine test | This is a safety outcome. | baseline， 8weeks（after treatment） |
| Stool routine test | This is a safety outcome. | baseline， 8weeks（after treatment） |
| Stool occult blood | This is a safety outcome. | baseline， 8weeks（after treatment） |
| Liver function-Alanine aminotransferase（ALT） | This is a safety outcome. | baseline， 8weeks（after treatment） |
| Liver function-Aspartate aminotransferase (AST) | This is a safety outcome. | baseline， 8weeks（after treatment） |
| Liver function-alkaline phosphatase (ALP) | This is a safety outcome. | baseline， 8weeks（after treatment） |
| Renal function-blood urea nitrogen (BUN) | This is a safety outcome. | baseline， 8weeks（after treatment） |
| Renal function-creatinine | This is a safety outcome. | baseline， 8weeks（after treatment） |
| Electrocardiogram | This is a safety outcome. | baseline， 8weeks（after treatment） |
| Adverse events | This is a safety outcome. | Up to 8 weeks |
| Serious adverse events | This is a safety outcome. | Up to 8 weeks |