Irritable Bowel Syndrome Clinical Trial
Official title:
A Randomized Double Blind Placebo Control Study of Xiang-Sha-Liu-Jun-Zi-Tang (XSLJZT)in Patients With Irritable Bowel Syndrome
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:
1. Setting up the environment and related equipment that enable the performance of
clinical studies in Chinese pharmacies and establishing the operation manuals and
standard operation procedures for performing the R&D stage for drugs of Chinese
pharmacies.
2. Employing professionals required in the clinical study in Chinese pharmacies and
encouraging doctors, pharmacists and nurses to attend advanced study and receive
training while enhancing the incubation for the required professionals of clinical
studies, such that the experience can be passed to others.
3. Practically performing one or more proposals of developing new drugs of Chinese
pharmacies or the clinical study proposal of reassessing therapeutic efficacies of
drugs in the drug permission certificates issued by the Committee on Chinese Medicine
and Pharmacy on record.
4. Promoting and building an intact and strong audit system in accordance with Good
Clinical Practice (GCP), elevating the clinical study level in our country, and putting
the regulations of GLP into practice.
5. Promoting the cooperation with industries, academics, and governments and international
cooperation.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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