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Studies of Traditional Chinese Medicine Clinical Efficacy Evaluation Index

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ClinicalTrials.gov Identifier: NCT01502943
Recruitment Status : Completed
First Posted : January 2, 2012
Last Update Posted : January 2, 2012
Sponsor:
Collaborator:
Ministry of Science and Technology of the People´s Republic of China
Information provided by (Responsible Party):
YANG Guan-lin, Liaoning University of Traditional Chinese Medicine

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Stable Angina Pectoris Drug: Louxiangdan Tongxin granules Drug: TCM granules placebo Drug: Chixiangshen Tongxin granules Drug: TCM granule placebo plus western basis treatment Drug: Western basis treatment Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Official Title: Studies of Traditional Chinese Medicine Clinical Efficacy Evaluation Index With Stable Angina Pectoris of Coronary Heart Disease as an Example
Study Start Date : May 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


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 Name: 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: TCM granules placebo
Chinese medicine granules placebo: once 100ml, twice per day after breakfast and supper.
Other Name: TCM placebo 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

Experimental: Qi deficiency and blood stasis G 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 Name: Chixiangshen 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: Qi deficiency and blood stasis control G Drug: TCM granule placebo plus western basis treatment
Chinese medicine granules placebo: once 100ml, twice per day after breakfast and supper.
Other Name: TCM placebo 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




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

Secondary Outcome Measures :
  1. Symptoms evaluative index: Measure Your Medical Outcome Profile (MYMOP), Angina incentives, symptom score scale, rate of nitroglycerin, angina classification, heart function classification [ Time Frame: 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 ]
  2. 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) [ Time Frame: Taken at expected day 7 in the screening period (baseline) and Change from Baseline in 8th week ]
  3. Quality of life evaluative index: Seattle angina questionnaire (SAQ) [ Time Frame: Taken at day 1 (baseline) , Change from Baseline in 2nd, 4th, 8th, 12th week ]
  4. Quality of life evaluative index: short form-12 (SF-12) [ Time Frame: Taken at day 1 (baseline), Change from Baseline in 2nd, 4th, 8th, 12th week ]
  5. TCM characteristics evaluative index: Traditional Chinese medicine Syndrome Scale 2 (criteria) [ Time Frame: Taken at expected day 7 in the Screening period,and Change from Baseline in 2nd,4th,8th week ]
  6. Endpoint index (Cardiovascular events, non-cardiovascular events, death, hospitalization due to coronary heart disease cases) [ Time Frame: Taken at 2nd, 4th, 8th, 12th, 26th week ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01502943


Locations
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China, Jilin
Affiliated hospital of Changchun university of TCM
Changchun, Jilin, China, 110000
Jilin integrative Chinese and western medicine hospital
Changchun, Jilin, China, 110000
China, Liaoning
Dalian integrative of Chinese and Western medicine hospital
Dalian, Liaoning, China, 110000
Dandong TCM hospital
Dandong, Liaoning, China, 110000
Fuxin TCM hospital
Fuxin, Liaoning, China, 110000
Affiliated hospital of Liaoning university of TCM 2
Shenyang, Liaoning, China, 110000
Affiliated hospital of Liaoning university of TCM
Shenyang, Liaoning, China, 110000
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China, 110000
Yingkou TCM hospital
Yingkou, Liaoning, China, 110000
China, Tianjin
Affiliated hospital of Tianjin university of TCM
Tianjin, Tianjin, China, 110000
Sponsors and Collaborators
Liaoning University of Traditional Chinese Medicine
Ministry of Science and Technology of the People´s Republic of China
Investigators
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Study Chair: Guanlin Yang Liaoning University of TCM

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Responsible Party: YANG Guan-lin, Principal of Liaoning university of TCM, Liaoning University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT01502943     History of Changes
Other Study ID Numbers: 2009ZX09502-029
First Posted: January 2, 2012    Key Record Dates
Last Update Posted: January 2, 2012
Last Verified: December 2011

Keywords provided by YANG Guan-lin, Liaoning University of Traditional Chinese Medicine:
Complementary Therapies
Traditional Chinese Medicine
Quality of life
Seattle angina questionnaire (SAQ)
SF-12
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)
clinical efficacy
evaluative index

Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Diseases
Angina Pectoris
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Angina, Stable
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Arteriosclerosis
Arterial Occlusive Diseases
Calcium
Aspirin
Atorvastatin
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors