Angina Pectoris Clinical Trial
Official title:
A Phase II, Double Blind, Placebo-controlled, Randominzed, Multi-Center, Parallel Group Study to Evaluate the Efficacy and Safety of T89 in Patient With Chronic Stable Angina Pectoris
The purpose of this study is to determine the anti-angina effect and dose response of T89, a 2-herb botanical drug product, in patients with chronic stable angina pectoris in the United States.
T89 is a modernized and industrialized version of a traditional Chinese herbal medicine. T89
was approved for marketing as a drug, for the treatment of chronic stable angina pectoris due
to coronary heart disease, by the State Food and Drug Administration (SFDA) of China in 1993.
There were more than 2 billion doses have been prescribed or used, in about 10,000,000
subjects, in short or long-term administration worldwide.
The product is also marketed, as a drug, in Russia, South Korea, Mongolia, Singapore,
Vietnam, and South Africa. The current study is to determine the anti-angina effect and dose
response of T89 in patients with chronic stable angina pectoris in the United States.
T89 consists of Danshen (Radix Salviae Miltiorrhizae, RSM) and Sanqi (Radix Notoginseng, RN)
as active constitutes, and using Borneol as transporting enhancer.
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