Studies of Traditional Chinese Medicine Clinical Efficacy Evaluation Index

Studies of Traditional Chinese Medicine Clinical Efficacy Evaluation Index With Stable Angina Pectoris of Coronary Heart Disease as an Example

The purpose of the trial is to take stable angina pectoris of coronary heart disease (CHD) as examples to build a standard evaluation system for efficacy of traditional Chinese medicine (TCM).

1. Studies of evaluating reliability, validity and reactivates of Patients Report Outcomes of CHD and self-administrated scale of Stable Angina Pectoris
2. research on all indicators of CHD, and analyze their characteristics, target and function
3. theory of Invigorating Spleen to Remove Phlegm or replenish Qi, and activating blood and dissolving stasis as an example for clinical efficacy evaluation.

Study Overview

• Status: Completed
• Conditions: Coronary Heart Disease; Stable Angina Pectoris
• Intervention / Treatment: Drug: Louxiangdan Tongxin granules; Drug: Western basis treatment; Drug: TCM granules placebo; Drug: Chixiangshen Tongxin granules; Drug: TCM granule placebo plus western basis treatment

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 480
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 110000
      • Affiliated Hospital of Changchun University of TCM
    • Changchun, Jilin, China, 110000
      • Jilin integrative Chinese and western medicine hospital
  • Liaoning
    • Dalian, Liaoning, China, 110000
      • Dalian integrative of Chinese and Western medicine hospital
    • Dandong, Liaoning, China, 110000
      • Dandong TCM hospital
    • Fuxin, Liaoning, China, 110000
      • Fuxin TCM hospital
    • Shenyang, Liaoning, China, 110000
      • Shengjing Hospital of China Medical University
    • Shenyang, Liaoning, China, 110000
      • Affiliated hospital of Liaoning university of TCM 2
    • Shenyang, Liaoning, China, 110000
      • Affiliated Hospital of Liaoning University of TCM
    • Yingkou, Liaoning, China, 110000
      • Yingkou TCM hospital
  • Tianjin
    • Tianjin, Tianjin, China, 110000
      • Affiliated hospital of Tianjin university of TCM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 43 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phlegm and blood stasis Syndrome G	Drug: Louxiangdan Tongxin granules; TCM treatment: Decoction: Louxiangdan Tongxin granules Herbs:Danshen 10g、Chenxiang 1g、Gualou10g、Xiebai 10g、Banxia6g、Chuanxiong 6g 、Dangshen 10g、Zhiqiao 6g、Taoren 10g、Guizhi 6g Therapeutic Principle:Invigorating Spleen to Remove Phlegm and activating blood and dissolving stasis, at least 6 kinds of TCM herbs can be chosen and their dosages be adjusted according to Syndrome Differentiation. Usage:Once 100ml, twice per day after breakfast and supper.; Other Names: Louxiangdan Tongxin granules from Jiangyin Tianjiang Pharmaceutical Co., Ltd; Drug: Western basis treatment; Aspirin: 100mg pd. P.O.( patients who have Aspirin resistance or Allergy can replaced with Piece clopidogrel 75mg pd. P.O.) Atorvastatin calcium (Lipitor): 10mg pd. P.O.( patients who have Atorvastatin calcium resistance or Allergy can replaced with Additive amount of pravastatin equal to 10mg Lipitor) Nitroglycerin: sublingual necessary.; Other Names: Aspirin from Liaoning WanLong medicine Co.,Ltd; Atorvastatin calcium (Lipitor) from Liaoning Pharmaceutical foreign trade corporation
Placebo Comparator: Phlegm and blood stasis control G	Drug: Western basis treatment; Aspirin: 100mg pd. P.O.( patients who have Aspirin resistance or Allergy can replaced with Piece clopidogrel 75mg pd. P.O.) Atorvastatin calcium (Lipitor): 10mg pd. P.O.( patients who have Atorvastatin calcium resistance or Allergy can replaced with Additive amount of pravastatin equal to 10mg Lipitor) Nitroglycerin: sublingual necessary.; Other Names: Aspirin from Liaoning WanLong medicine Co.,Ltd; Atorvastatin calcium (Lipitor) from Liaoning Pharmaceutical foreign trade corporation; Drug: TCM granules placebo; Chinese medicine granules placebo: once 100ml, twice per day after breakfast and supper.; Other Names: TCM placebo granules from Jiangyin Tianjiang Pharmaceutical Co., Ltd
Experimental: Qi deficiency and blood stasis G	Drug: Western basis treatment; Aspirin: 100mg pd. P.O.( patients who have Aspirin resistance or Allergy can replaced with Piece clopidogrel 75mg pd. P.O.) Atorvastatin calcium (Lipitor): 10mg pd. P.O.( patients who have Atorvastatin calcium resistance or Allergy can replaced with Additive amount of pravastatin equal to 10mg Lipitor) Nitroglycerin: sublingual necessary.; Other Names: Aspirin from Liaoning WanLong medicine Co.,Ltd; Atorvastatin calcium (Lipitor) from Liaoning Pharmaceutical foreign trade corporation; Drug: Chixiangshen Tongxin granules; TCM treatment: Decoction: Chixiangshen Tongxin granules Herbs: Chishao 10g, Chenxiang 1g, Danggui 10g, Jupi 10g, Yanhusuo 6g, Chuanxiong 6g, Dangshen 10g, Huangqi 6g, Taoren 10g, Honghua 10g Therapeutic Principle:Invigorating Spleen to Replenish Qi and activating blood and dissolving stasis, at least 6 kinds of TCM herbs can be chosen and their dosages be adjusted according to Syndrome Differentiation. Usage:Once 100ml, twice per day after breakfast and supper.; Other Names: Chixiangshen Tongxin granules from Jiangyin Tianjiang Pharmaceutical Co., Ltd
Placebo Comparator: Qi deficiency and blood stasis control G	Drug: Western basis treatment; Aspirin: 100mg pd. P.O.( patients who have Aspirin resistance or Allergy can replaced with Piece clopidogrel 75mg pd. P.O.) Atorvastatin calcium (Lipitor): 10mg pd. P.O.( patients who have Atorvastatin calcium resistance or Allergy can replaced with Additive amount of pravastatin equal to 10mg Lipitor) Nitroglycerin: sublingual necessary.; Other Names: Aspirin from Liaoning WanLong medicine Co.,Ltd; Atorvastatin calcium (Lipitor) from Liaoning Pharmaceutical foreign trade corporation; Drug: TCM granule placebo plus western basis treatment; Chinese medicine granules placebo: once 100ml, twice per day after breakfast and supper.; Other Names: TCM placebo granules from Jiangyin Tianjiang Pharmaceutical Co., Ltd

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
TCM characteristics evaluative index: Traditional Chinese medicine SYndrome Scale (TCMsys) (new developed）	Taken at day 1 (baseline) and Change from Baseline in 2nd,4th,8th week
New developed Quality of life evaluative index: patients report outcomes for SAP	Taken at expected day 7 in the screen period, day 1 (baseline) and Change from Baseline in 2nd,4th,8th week
New developed Quality of life evaluative index: self-administrated scale of SAP	Taken at expected day 7 in the screen period, day 1 (baseline) and Change from Baseline in 2nd,4th,8th week

Secondary Outcome Measures

Outcome Measure	Time Frame
Symptoms evaluative index: Measure Your Medical Outcome Profile (MYMOP), Angina incentives, symptom score scale, rate of nitroglycerin, angina classification, heart function classification	Taken at day 1 (baseline) and Change from Baseline in 2nd,4th,8th week; and all except MYMOP taken one more at expected day 7 in screen
Biochemical index: ECG, ECG exercise test, blood lipids, blood glucose (fasting glucose), Blood, urine, liver function, renal function, coagulation, echocardiography (including heart function), coronary CT (some hospitals choose to do)	Taken at expected day 7 in the screening period (baseline) and Change from Baseline in 8th week
Quality of life evaluative index: Seattle angina questionnaire (SAQ)	Taken at day 1 (baseline) , Change from Baseline in 2nd, 4th, 8th, 12th week
Quality of life evaluative index: short form-12 (SF-12)	Taken at day 1 (baseline), Change from Baseline in 2nd, 4th, 8th, 12th week
TCM characteristics evaluative index: Traditional Chinese medicine Syndrome Scale 2 (criteria)	Taken at expected day 7 in the Screening period,and Change from Baseline in 2nd,4th,8th week
Endpoint index （Cardiovascular events, non-cardiovascular events, death, hospitalization due to coronary heart disease cases）	Taken at 2nd, 4th, 8th, 12th, 26th week

Collaborators and Investigators

• Sponsor: Liaoning University of Traditional Chinese Medicine
• Collaborators: Ministry of Science and Technology of the People´s Republic of China
• Investigators: Study Chair: Guanlin Yang, Liaoning University of TCM

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: December 15, 2011
• First Submitted That Met QC Criteria: December 30, 2011
• First Posted (Estimate): January 2, 2012

Study Record Updates

• Last Update Posted (Estimate): January 2, 2012
• Last Update Submitted That Met QC Criteria: December 30, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: Quality of life; Traditional Chinese Medicine; Complementary Therapies; clinical efficacy; SF-12; Seattle angina questionnaire (SAQ); Measure Your Medical Outcome Profile (MYMOP); Phlegm and blood stasis Syndrome; Qi deficiency and blood stasis Syndrome; Invigorating Spleen to Remove Phlegm or replenish Qi; Activating blood and dissolving stasis; Traditional Chinese medicine SYndrome Scale (TCMsys); Patients Report Outcomes(PRO); evaluative index
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Chest Pain; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Angina Pectoris; Angina, Stable; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin
• Other Study ID Numbers: 2009ZX09502-029