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Clinical trials of Compound Salvia Dropping Pills (Danshen Diwan)

Randomized, double-blind, parallel-controlled trial of improved formulations of CSDP on angina pectoris

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-09000576
Enrollment
Unknown
Registered
2009-10-21
Start date
2009-11-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angina

Interventions

A:Improved CSDP 10pills tid 28days
B:original CSDP 10pills tid 28days

Sponsors

Tianjin Tasly Pharmaceutical Group
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Comply with Western stable angina pectoris (III level and below) diagnosed as the Qi stagnation blood stasis syndrome of TCM; 2. Average of weekly angina attacks in patients with >=2 times per week before 4 weeks before; 3. General performance with ischemic ECG: ST segment depression >=0.1mv and / or R-wave as the leading United T-wave inversion and deep> 0.2mv; normal ECG ST segment depression >=0.05mv, and <0.1 mv persons, treadmill test positive (see Program Annex: exercise stress test SOP); 4. Age 45-70 years old, male or female; 5. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. History of myocardial infarction, a preinfarction symptoms, resting angina occur from time to time, anything that might invalidate the results of the disease studies exist at least 3 months before; 2. Confirmed as acute myocardial infarction with coronary heart disease, IV grade (labor type) / severe (spontaneous) angina and other heart disease, severe neurosis, menopausal syndrome, hyperthyroidism, cervical disease, gall bladder heart disease, stomach and esophageal reflux, esophageal hiatal hernia, aortic dissection and other diseases other than coronary artery disease caused by chest pain; 3. Combined with hypertension and blood pressure by antihypertensive drug treatment were still higher (systolic blood pressure >=160mmHg, diastolic blood pressure >=100mmHg), severe heart and lung failure, severe arrhythmias (fast atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia, etc.), liver, kidney, hematopoietic system of primary and other serious diseases, mental illness; 4. Coronary artery disease by coronary bypass, interventional treatment of vascular completely rebuilt less than six months are; 5. Allergic to the drug component; 6. Pregnancy and prepare for pregnancy or breast-feeding women; 7. The law requires patients with disabilities (blind, deaf, mute, mental retardation, mental illness, etc.); 8. Over the past month to participate in other clinical trials of patients; 9. Over the past one month, used for liver and kidney function have a significant effect of the drugs.

Design outcomes

Primary

MeasureTime frame
Angina Efficacy;

Secondary

MeasureTime frame
SAQ;Nitroglycerin stop rate cut;Anticoagulation;Treadmill test;ECG effect;

Countries

China

Contacts

Public ContactLanjun Sun
lzy840819@126.com+86 022-60335360

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026