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:
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.
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.
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.
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.
Promoting the cooperation with industries, academics, and governments and international
cooperation.