How to establish precise proprietary Chinese medicine in post-marketing reappraisal?
Journal Title: Traditional Medicine Research - Year 2017, Vol 2, Issue 4
Abstract
The clinical efficacy and safety of proprietary Chinese medicine has become a more prevailing public health concern. The China Food and Drug Administration has pushed drug companies to conduct post-marketing reappraisal for proprietary Chinese medicine to provide additional evidence supporting the efficacy and safety of these medicine. In this paper, we propose a reappraisal protocol called “precise proprietary Chinese medicine” to precisely i) define the therapeutic aim; ii) design the protocol; iii) control the quality of proprietary Chinese medicine; iv) implement the protocol in the trial; v) study the mechanism-of-action of the proprietary Chinese medicine and vi) describe the indications of the proprietary Chinese medicine. We hope that these steps facilitate the post-marketing reappraisal of proprietary Chinese medicine.
Authors and Affiliations
Tian Ran, Dai Liang, Shang Hong-Cai, Li You-Ping, Bian Zhao-Xiang
Gastrointestinal effects of Artemisia absinthium Linn. based on traditional Persian medicine and new studies
One of the most extensively used herbs in traditional Persian medicine (TPM) used in the treatment of gastrointestinal (GI) disorders, is the plant Artemisia absinthium Linn. (AAL). It also has a wide range of activities...
Marine natural products with anti-inflammation effects
The ocean possesses a complex setting with high pressure, high salinity, oligotrophy, low temperature and weak illumination conditions. To survive and evolve in such harsh surroundings, marine organisms metabolize a seri...
A new idea of electro-acupuncture treatment for peripheral facial paralysis and the nerve-endocrine hypothesis
According to the distribution of facial nerve and its dominant muscles, 10 acupoints were selected. Prefrontal area: Acupoint 1, move inward 0.5cm horizontally from Yangbai (GB 14). Acupoint 2, the medial point on the li...
Effects of chicory (Cichorium intybus L.) on nonalcoholic fatty liver disease
There is a dramatic increase in the prevalence of nonalcoholic fatty liver disease, which is slowly turning into a pandemic as well as a major challenge across the world. Nonalcoholic fatty liver disease is described as...
Hua-Zhuo-Kai-Yu decoction inhibits apoptosis in nonalcoholic fatty liver disease
Background: Hua-Zhuo-Kai-Yu decoction (HZKY) is an empirical formula in traditional Chinese medicine that is derived from the classic ancient prescription Da-Chai-Hu decoction. It has been demonstrated to have good clini...