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
Angine de Poitrine+9
+ Maladies Cardiovasculaires
+ Douleur thoracique
Résumé
Date de début de l'étude : 1 mai 2011
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.480 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 45 à 75 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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 l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.4 groupes d'intervention sont désignés dans cette étude
50% de chances d'être dans le groupe placebo en aveugle
Groupes de traitement
Groupe I
ExpérimentalGroupe II
PlaceboGroupe III
ExpérimentalGroupe IV
PlaceboObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 10 sites
Affiliated hospital of Changchun university of TCM
Changchun, ChinaOuvrir Affiliated hospital of Changchun university of TCM dans Google MapsJilin integrative Chinese and western medicine hospital
Changchun, ChinaDalian integrative of Chinese and Western medicine hospital
Dalian, ChinaDandong TCM hospital
Dandong, China