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Ministry of Health and Welfare Department of Chinese Medicine and pharmacy specially subsidizes domestic teaching hospitals to install clinical study centers for Chinese pharmacies, in order to establish the clinical study environment for Chinese pharmacies meeting the international regulations, to assist promoting and performing clinical studies in Chinese pharmacies, and then to improve the nation's health and benefits. This will render Chinese pharmacies competitive in the international market by employing scientific tests and verifications. The new project applications are respectively as follows: A randomized double blind placebo control study of Xiang-Sha-Liu-Jun-Zi-Tang (XSLJZT) in patients with irritable bowel syndrome The main clinical manifestations of irritable bowel syndrome (IBS) are chronic, recurrent abdominal pain or abdominal dyscomfortable associated with the changes of defecation habit, such as constipation and/or diarrhea. Clinical treatment of IBS includes behavioral, and drug treatment, such as anti-diarrheal agent, 5-HT3 receptor antagonist and 5-HT4 receptor agonist, but these treatments relieve partial symptoms only. Xiang-Sha-Liu-Jun-Zi-Tang (XSLJZT) origins from Yizongjinjion, and that uses XSLJZT to treat the patients who has qi deficiency, phlegm-retained fluid, nausea and vomiting, gastrointestinal dysharmony and producing many symptoms. These symptoms of mentioned-above are similar to IBS. Therefore, the purpose of the present study was to investigate the therapeutic effect of XSLJZT on IBS, the investigators designed a randomized double blind placebo control study to assess the effect of XSLJZT on IBS.
Ministry of Health and Welfare Department of Chinese Medicine and pharmacy specially subsidizes domestic teaching hospitals to install clinical study centers for Chinese pharmacies, in order to establish the clinical study environment for Chinese pharmacies meeting the international regulations, to assist promoting and performing clinical studies in Chinese pharmacies, and then to improve the nation's health and benefits. This will render Chinese pharmacies competitive in the international market by employing scientific tests and verifications. The new project applications are respectively as follows: A randomized double blind placebo control study of Xiang-Sha-Liu-Jun-Zi-Tang (XSLJZT) in patients with irritable bowel syndrome The main clinical manifestations of irritable bowel syndrome (IBS) are chronic, recurrent abdominal pain or abdominal dyscomfortable associated with the changes of defecation habit, such as constipation and/or diarrhea. Clinical treatment of IBS includes behavioral, and drug treatment, such as anti-diarrheal agent, 5-HT3 receptor antagonist and 5-HT4 receptor agonist, but these treatments relieve partial symptoms only. Xiang-Sha-Liu-Jun-Zi-Tang (XSLJZT) origins from Yizongjinjion, and that uses XSLJZT to treat the patients who has qi deficiency, phlegm-retained fluid, nausea and vomiting, gastrointestinal dysharmony and producing many symptoms. These symptoms of mentioned-above are similar to IBS. Therefore, the purpose of the present study was to investigate the therapeutic effect of XSLJZT on IBS, we designed a randomized double blind placebo control study to assess the effect of XSLJZT on IBS.
In addition to the performance of the clinical study projects for Chinese pharmacies, our center will still maintain cooperation with domestic or foreign biotechnology industries, the industries of Chinese herbal medicine and academic research institutes, such as the material research institute in Industrial Technology Research Institute, Feng Chia University, and Yuanpei University, make efforts in expanding the study in the development of novel Chinese medicinal drugs and novel medical techniques, and cooperate with famous international Contract Research Organizations (CRO). We want to build a clinical study service platform, in which the internal part is to integrate various R&D units on campuses and hospitals, such as the teams in the department of medical care, department of medical technology, all laboratories, the incubation center, the biostatistics center, the administrative department and improve the internal procedures for performing clinical studies. The external part is to make efforts to win over domestic and foreign clinical study cases to be performed in our center. The performing methods are illustrated as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xiang-Sha-Liu-Jun-Zi-Tang | Experimental | Xiang-Sha-Liu-Jun-Zi-Tang at a rate of 3.0 g three times per day for 28 days |
|
| Placebo | Placebo Comparator | Placebo at a rate of 3.0 g three times per day for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xiang-Sha-Liu-Jun-Zi-Tang | Drug | Xiang-Sha-Liu-Jun-Zi-Tang at a rate of 3.0 g three times per day for 28 days. We use the Chinese herb for the treat of IBS patient |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal System Rating Scale-IBS Questionnaire | Change from baseline Gastrointestinal System Rating Scale-IBS score at week 4 (28 ± 5 days) and week 12 (84 ± 7 days) |
| Measure | Description | Time Frame |
|---|---|---|
| IBS-QOL Questionnaire | Change from baseline IBS-QOL score at week 4 (28 ± 5 days) and week 12 (84 ± 7 days) |
| Measure | Description | Time Frame |
|---|---|---|
| WHO Quality Questionnaire | Change from baseline WHO Quality of Life-BREF score at week 4 (28 ± 5 days) and week 12 (84 ± 7 days) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hsueh-Chou Lai | Contact | +886-4-22052121 | d3145@mail.cmuh.org.tw |
| Name | Affiliation | Role |
|---|---|---|
| Hsuehchou Lai, MD | China Medical University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Medical University Hospital | Recruiting | Taichung | Taiwan |
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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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| Placebo | Drug | Xiang-Sha-Liu-Jun-Zi-Tang at a rate of 3.0 g three times per day for 28 days. Placebo drug is 1/10 dose of experiment drug . |
|
| D004066 | Digestive System Diseases |