Studies of Traditional Chinese Medicine Clinical Efficacy Evaluation Index

Phase 4

Completed

• Conditions: Coronary Heart Disease; Stable Angina Pectoris
• Interventions: Drug: Louxiangdan Tongxin granules; Drug: TCM granules placebo; Drug: Chixiangshen Tongxin granules; Drug: TCM granule placebo plus western basis treatment; Drug: Western basis treatment

• Registration Number: NCT01502943
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2011-05
• Status Verified: 2011-12
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Study First Submitted: 2011-12-15
• Study First Submitted QC: 2011-12-30
• Last Update Submitted: 2011-12-30
• Study First Posted: 2012-01-02
• Last Update Posted: 2012-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phlegm and blood stasis Syndrome G	Louxiangdan Tongxin granules	-
Phlegm and blood stasis Syndrome G	Western basis treatment	-
Phlegm and blood stasis control G	TCM granules placebo	-
Phlegm and blood stasis control G	Western basis treatment	-
Qi deficiency and blood stasis G	Chixiangshen Tongxin granules	-
Qi deficiency and blood stasis G	Western basis treatment	-
Qi deficiency and blood stasis control G	TCM granule placebo plus western basis treatment	-
Qi deficiency and blood stasis control G	Western basis treatment	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (10)

Dalian integrative of Chinese and Western medicine hospital; 🇨🇳 Dalian, Liaoning, China

Affiliated hospital of Tianjin university of TCM; 🇨🇳 Tianjin, Tianjin, China

Affiliated hospital of Liaoning university of TCM 2; 🇨🇳 Shenyang, Liaoning, China

Affiliated hospital of Changchun university of TCM; 🇨🇳 Changchun, Jilin, China

Dandong TCM hospital; 🇨🇳 Dandong, Liaoning, China

Jilin integrative Chinese and western medicine hospital; 🇨🇳 Changchun, Jilin, China

Fuxin TCM hospital; 🇨🇳 Fuxin, Liaoning, China

Affiliated hospital of Liaoning university of TCM; 🇨🇳 Shenyang, Liaoning, China

Shengjing Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China

Yingkou TCM hospital; 🇨🇳 Yingkou, Liaoning, China