Studies of Traditional Chinese Medicine Clinical Efficacy Evaluation Index With Stable Angina Pectoris of Coronary Heart Disease as an Example
Louxiangdan Tongxin granules
+ Western basis treatment
+ TCM granules placebo
Angina de Pecho+7
+ Enfermedades Cardiovasculares
+ Dolor en el pecho
Resumen
Fecha de inicio: 1 de mayo de 2011
Fecha en la que se inscribió al primer participante.Clinical efficacy is the basis of traditional Chinese medicine development, and scientific evaluation of TCM clinical efficacy and its effectiveness is the way to push TCM modernized and international. TCM theories of Overall concept and Differentiation for life science and diseases are hard to be generally accepted. Besides, no unified and standard methods fit to evaluate the TCM clinical efficacy. Thus, there is a need to do a deeper research of methodology, evaluative index, and evaluative criteria in order to guide the evaluation of TCM clinical efficacy. Based on the situation above, the study aims to choose the best and characteristic evaluative index of clinical efficacy, compare the demand among practitioners, patients and care givers. After data collected, a new cluster of index among Biochemical, patients report outcomes, endpoint indicators, and TCM soft indicators could be constituted and analyzed to use in respective way according to their characteristics, target and function.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 480 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 45 a 75 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion criterion: * The diagnosis standard according with stable angina coronary heart disease * The participants with any one of the below six standards are included: * history of myocardial infarction previously * PCI postoperative patients * CT showing more than 50% coronary stenosis * Coronary angiography showing more than 50% coronary stenosis * positive results of the electrocardiogram * ischemia changes in the electrocardiogram recently * The Patients with disease history more than three months, attacked in the recent one month * Standard according to the phlegm and blood stasis syndrome or Qi deficiency and blood stasis syndrome of the traditional Chinese medicine * Male: 45 years old \< 75 years old * Female: 50 years old \< 75 years old * Participants signed the agreement paper voluntarily. Exclusion criterion: * Participants with Acute coronary syndrome (ST segment elevation myocardial infarction, non ST segment elevation myocardial infarction, unstable angina), asymptomatic myocardial ischemia,ischemic cardiomyopathy,the myocardial infarction happening in the 3 months before the test * Participants with rheumatism heart disease, hyper thyroid heart disease, hypertensive heart disease, myocarditis, cardiomyopathy * Participants with Cervical disease, gallbladder cardiac syndrome, stomach and esophageal reflux, aortic dissection * Participants with acute cerebral infarction and cerebral hemorrhage * Participants with severe heart failure, lung function, liver function (AST, ALT 1.5 times normal standard), kidney function (BUN, Cr more than the normal standard), hematopoietic system and endocrine systems and serious primary disease, malignant tumor, gastrointestinal bleeding, gastric ulcer and are prone to bleed * the Participants can not complete the whole test * The serious high blood pressure and hard to control (SBP \>= 180 mmHg or DBP \>=110 mmHg) * Participants of acute or chronic cardiac dysfunction with heart function III-IV * Participants has been included in other clinical studies in one month; * Participants with glaucoma * Participants with Pregnancy Or Lactation ,Allergy * Participants with mental disorder, or nervous disease, or illiteracy, or bad compliance for questionnaire
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.4 grupos de intervención están designados en este estudio
50% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
PlaceboGrupo III
ExperimentalGrupo IV
PlaceboObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 10 ubicaciones
Affiliated hospital of Changchun university of TCM
Changchun, ChinaAbrir Affiliated hospital of Changchun university of TCM en Google MapsJilin integrative Chinese and western medicine hospital
Changchun, ChinaDalian integrative of Chinese and Western medicine hospital
Dalian, ChinaDandong TCM hospital
Dandong, China