Studies of Traditional Chinese Medicine Clinical Efficacy Evaluation Index

NCT01502943 | Completed Phase 4 DMC

• 1 other identifier: 2009ZX09502-029
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 10

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

Conditions

Coronary Heart Disease; Stable Angina Pectoris

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• 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

Study Arms (4)

Phlegm and blood stasis Syndrome G

EXPERIMENTAL

Drug: Louxiangdan Tongxin granules; Drug: Western basis treatment

Phlegm and blood stasis control G

PLACEBO COMPARATOR

Drug: TCM granules placebo; Drug: Western basis treatment

Qi deficiency and blood stasis G

EXPERIMENTAL

Drug: Chixiangshen Tongxin granules; Drug: Western basis treatment

Qi deficiency and blood stasis control G

PLACEBO COMPARATOR

Drug: TCM granule placebo plus western basis treatment; Drug: Western basis treatment

Interventions

Louxiangdan Tongxin granules DRUG

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.

Also known as: Louxiangdan Tongxin granules from Jiangyin Tianjiang Pharmaceutical Co., Ltd

Phlegm and blood stasis Syndrome G

TCM granules placebo DRUG

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

Also known as: TCM placebo granules from Jiangyin Tianjiang Pharmaceutical Co., Ltd

Phlegm and blood stasis control G

Chixiangshen Tongxin granules DRUG

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.

Also known as: Chixiangshen Tongxin granules from Jiangyin Tianjiang Pharmaceutical Co., Ltd

Qi deficiency and blood stasis G

TCM granule placebo plus western basis treatment DRUG

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

Also known as: TCM placebo granules from Jiangyin Tianjiang Pharmaceutical Co., Ltd

Qi deficiency and blood stasis control G

Western basis treatment DRUG

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.

Also known as: Aspirin from Liaoning WanLong medicine Co.,Ltd, Atorvastatin calcium (Lipitor) from Liaoning Pharmaceutical foreign trade corporation

Phlegm and blood stasis Syndrome G; Phlegm and blood stasis control G; Qi deficiency and blood stasis G; Qi deficiency and blood stasis control G

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Liaoning University of Traditional Chinese Medicine: lead
• Ministry of Science and Technology of the People´s Republic of China: collaborator

Study Sites (10)

Affiliated hospital of Changchun university of TCM

Changchun, Jilin, 110000, China

Location

Jilin integrative Chinese and western medicine hospital

Changchun, Jilin, 110000, China

Location

Dalian integrative of Chinese and Western medicine hospital

Dalian, Liaoning, 110000, China

Location

Dandong TCM hospital

Dandong, Liaoning, 110000, China

Location

Fuxin TCM hospital

Fuxin, Liaoning, 110000, China

Location

Affiliated hospital of Liaoning university of TCM 2

Shenyang, Liaoning, 110000, China

Location

Affiliated hospital of Liaoning university of TCM

Shenyang, Liaoning, 110000, China

Location

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110000, China

Location

Yingkou TCM hospital

Yingkou, Liaoning, 110000, China

Location

Affiliated hospital of Tianjin university of TCM

Tianjin, Tianjin Municipality, 110000, China

Location

MeSH Terms

Conditions

Coronary Disease; Angina, Stable

Interventions

Long-Term Synaptic Depression; Atorvastatin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neuronal Plasticity; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Guanlin Yang

  Liaoning University of TCM

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal of Liaoning university of TCM

Study Record Dates

• First Submitted: December 15, 2011
• First Posted: January 2, 2012
• Study Start: May 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 2, 2012

Record last verified: 2011-12

Locations

CN (10)