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Coronary Heart DiseasePhase 4NCT01502943

Studies of Traditional Chinese Medicine Clinical Efficacy Evaluation Index

A Phase 4 study testing Louxiangdan Tongxin granules, Chixiangshen Tongxin granules and Western basis treatment in people with Coronary Heart Disease and Stable Angina Pectoris, run by Liaoning University of Traditional Chinese Medicine at 10 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 45 to 75 yearsHealthy volunteers can take part
What is being tested?
Louxiangdan Tongxin granules, Chixiangshen Tongxin granules and Western basis treatment
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
480 participants
Where
10 sitesChina
Study dates
May 2011to Dec 2011
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

China10 sites

  • Affiliated hospital of Changchun university of TCM

    Changchun, Jilin, 110000

  • Jilin integrative Chinese and western medicine hospital

    Changchun, Jilin, 110000

  • Dalian integrative of Chinese and Western medicine hospital

    Dalian, Liaoning, 110000

  • Dandong TCM hospital

    Dandong, Liaoning, 110000

  • Fuxin TCM hospital

    Fuxin, Liaoning, 110000

  • Affiliated hospital of Liaoning university of TCM 2

    Shenyang, Liaoning, 110000

  • Affiliated hospital of Liaoning university of TCM

    Shenyang, Liaoning, 110000

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110000

  • Affiliated hospital of Tianjin university of TCM

    Tianjin, Tianjin Municipality, 110000

  • Yingkou TCM hospital

    Yingkou, Liaoning, 110000

Other trials in China

About this study

Official title: 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.
Read the 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.

Being tested
Louxiangdan Tongxin granules, TCM granules placebo, Chixiangshen Tongxin granules, TCM granule placebo plus western basis treatment, Western basis treatment
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
Medical subject headings
Coronary Disease, Angina, Stable

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Louxiangdan Tongxin granulesDrug

    Also called Louxiangdan Tongxin granules from Jiangyin Tianjiang Pharmaceutical Co., Ltd

    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.

  • TCM granules placeboDrug

    Also called TCM placebo granules from Jiangyin Tianjiang Pharmaceutical Co., Ltd

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

  • Chixiangshen Tongxin granulesDrug

    Also called Chixiangshen Tongxin granules from Jiangyin Tianjiang Pharmaceutical Co., Ltd

    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.

  • TCM granule placebo plus western basis treatmentDrug

    Also called TCM placebo granules from Jiangyin Tianjiang Pharmaceutical Co., Ltd

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

  • Western basis treatmentDrug

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

    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.

Study groups in NCT01502943
Study groupRoleWhat they receive
Phlegm and blood stasis Syndrome GExperimentalNot described
Receives: Drug: Louxiangdan Tongxin granules; Drug: Western basis treatment
Phlegm and blood stasis control GPlacebo comparatorNot described
Receives: Drug: TCM granules placebo; Drug: Western basis treatment
Qi deficiency and blood stasis GExperimentalNot described
Receives: Drug: Chixiangshen Tongxin granules; Drug: Western basis treatment
Qi deficiency and blood stasis control GPlacebo comparatorNot described
Receives: Drug: TCM granule placebo plus western basis treatment; Drug: Western basis treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. TCM characteristics evaluative index: Traditional Chinese medicine SYndrome Scale (TCMsys) (new developed）

    Measured: 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

    Measured: 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

    Measured: Taken at expected day 7 in the screen period, day 1 (baseline) and Change from Baseline in 2nd,4th,8th week

Secondary outcomes (6)

  1. Symptoms evaluative index: Measure Your Medical Outcome Profile (MYMOP), Angina incentives, symptom score scale, rate of nitroglycerin, angina classification, heart function classification

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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）

    Measured: Taken at 2nd, 4th, 8th, 12th, 26th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2012 (estimated)
  2. Study startMay 2011
  3. Primary completionDec 2011
  4. Study completionDec 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
480 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01502943
Sponsor's protocol ID
2009ZX09502-029
Status last verified
Dec 2011
First submitted
15 Dec 2011
Last updated
2 Jan 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Louxiangdan Tongxin granules, Chixiangshen Tongxin granules and Western basis treatment in people with Coronary Heart Disease and Stable Angina Pectoris, run by Liaoning University of Traditional Chinese Medicine at 10 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01502943.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2012.

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