Skip to content

A multicenter, randomized, double-blind, placebo parallel controlled clinical trial on the Regulating the spleen and protecting the heart therapy for improving exercise tolerance in patients with stable angina:randomized, double-blind, placebo-controlled, multi-center clinical trial study

Clinical trial on the effectiveness of regulating the spleen to protect heart therapy to exercise capacity of stable angina patients of a syndrome of qi deficiency with phlegm and blood stasis

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-14004504
Enrollment
Unknown
Registered
2014-04-12
Start date
2014-04-28
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

Stable Angina

Interventions

Experimental:Revised "Shensu Huxin" decoction

Sponsors

Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18-70 years; (2) Angina classification II-III; (3) Can be relieved quickly after nitrate esters while angina pectoris attacks; (4) Be able to complete the exercise test and with positive result; (5) Informed consent.

Exclusion criteria

Exclusion criteria: (1) Myocardial infarction, unstable angina pectoris, or Coronary artery revascularization (surgical bypass operation or angioplasty) history in 3 months; (2) With other heart diseases, neurosis, climacteric syndrome, hyperthyrea, cervical spondylosis, Gallbladder cardiac syndrome, Gastro esophageal reflux disease, or hiatal hernia which can also cause chest pain; (3) Abnormal appearance of resting electrocardiogram as follows: complete left bundle branch block, pre-excitation syndrome, Ventricular pacing rhythm, ST segment depression more chan 0.1mv, or left ventricular hypertrophy; (4) With uncomtrolled symptomatic heart failure or left ventricular ejection fraction =40% on cardiogram; (5) With ralative or absolute contraindication of exercise load test: Left main coronary artery stenosis, in severe stenosis valvular heart disease, electrolyte abnormalities, severe hypertension, hypertrophic cardiomyopathy or other types of outflow obstruction; (6) With tachyar rhythmia or slow arrhythmia which requests treatments; (7) Active liver disease, or with agnogenic persistent rising of serum transaminase, or ALT?AST>2 times of the high limits of the normal reference value; (8) Abnormal renal function (serum creatinine > high limit of the normal reference value); (9) In combination of severe primary disease of respiratory apparatus, hematopoietic system, or malignant tumor; (10) Pregnant women, lactating women, or women of childbearing age with fertility requirements; (11) Patients with mental disorders or cognitive dysfunction; (12) Patients who are with bad compliance, not able to be interviewed regularly, or not able to fill the Patients' Diary Card according to the doctors' requirements; (13) Attended other clinical trials or already accepted the random group dividing in this trial; (14) Other situations that the researchers consider not fit for this trial.

Design outcomes

Primary

MeasureTime frame
Treadmill test standard;Angina episodes;ECG standard;Echocardiography;Standards of TCM symptoms;Safety Evaluation;Adverse event;

Countries

China

Contacts

Public ContactHuanlin Wu

Guangdong Provincial Hospital of Chinese Medicine

wuhuanlinboshi@yahoo.com.cn+86 13822212111

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 5, 2026