Studies of Traditional Chinese Medicine Clinical Efficacy Evaluation Index

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01502943
Study type	Interventional
Source	Liaoning University of Traditional Chinese Medicine
Contact
Status	Completed
Phase	Phase 4
Start date	May 2011
Completion date	December 2011

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05196659` - Collaborative Quality Improvement (C-QIP) Study	N/A
Completed	`NCT05088291` - Application of a New X-ray Protective Device in Coronary Interventional Therapy
Completed	`NCT03076801` - Does Choral Singing Help imprOve Stress in Patients With Ischemic HeaRt Disease?	N/A
Completed	`NCT04584645` - A Digital Flu Intervention for People With Cardiovascular Conditions	N/A
Not yet recruiting	`NCT04995159` - Optimized Antiplatelet Therapy in Patients With CHD After Implantation of NeoVas™ BRS System	N/A
Recruiting	`NCT02967718` - Innovation Research of Differentiation and Treatment Methods Based on CHD Phlegm and Blood Stasis Syndrome	N/A
Completed	`NCT02888652` - Study on the Registration of Coronary Heart Disease Patients Undergoing PCI
Terminated	`NCT02045134` - Supplementation With Polyphenol-Rich Foods and Atrial Fibrillation After a Cardiac Surgery	N/A
Completed	`NCT02163044` - The Hellenic Postprandial Lipemia Study (HPLS)
Active, not recruiting	`NCT02244853` - Heart Rate and Cardiovascular Diseases Prognosis in People With Stable Coronary Artery Disease	N/A
Completed	`NCT01826552` - Comparison of the Angiographic Result of the Orsiro Hybrid Stent With Resolute Integrity Stent	Phase 4
Completed	`NCT02440893` - Understanding the Effect of Metformin on Corus CAD (or ASGES)
Completed	`NCT01920009` - Impact of Motivational Interviews Within Pharmacy Care Upon Adherence to Cardiovascular Medicines	N/A
Completed	`NCT02753829` - Home-based Cardiovascular Rehabilitation, Maintenance Phase, in Subjects With Coronary Artery Disease	N/A
Terminated	`NCT01906957` - Cognition and Exercise Training	N/A
Recruiting	`NCT01689688` - Healing Response to Everolimus-eluting Stent Implantation; Serial Assessment With opticaL Coherence Tomography	N/A
Completed	`NCT01779401` - Clopidogrel Response Evaluation and AnTi-Platelet InterVEntion in High Thrombotic Risk PCI Patients	N/A
Recruiting	`NCT01462799` - COR-PRIM: Problem-based Learning (PBL) After Coronary Heart Disease (CHD) - Long-term Evaluation in Primary Care of Self-care	N/A
Recruiting	`NCT01456364` - Intracoronary Stenting and Antithrombotic Regimen: ADjusting Antiplatelet Treatment in PatienTs Based on Platelet Function Testing	Phase 4
Completed	`NCT01486030` - Effect of Exercise Stress Testing on Peripheral Gene Expression Using Corus CAD (or ASGES) Diagnostic Test

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.