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Observation on the clinical efficacy of Shen Ge San combined with enhanced external counterpulsation in improving chronic heart failure

Observation on the clinical efficacy of Shen Ge San combined with enhanced external counterpulsation in improving chronic heart failure

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071967
Enrollment
Unknown
Registered
2023-05-30
Start date
2023-06-01
Completion date
Unknown
Last updated
2023-06-12

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

Conditions

chronic heart failure

Interventions

Shen Ge San Group:On the basis of standard Western medicine treatment (valsartan 40/80mg qd po, spironolactone 20mg qd/bid po, metoprolol 12.5mg/25mg qd/bid po
) combined with EECP treatment, take Shen Ge San twice a day, 3g each time
control group:On the basis of standard Western medicine treatment (valsartan 40/80mg qd po, spironolactone 20mg qd/bid po, metoprolol 12.5mg/25mg qd/bid po
) combined with EECP, take a placebo twice a day, 3g each time

Sponsors

Shanghai Jing'an District Shibei Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1) Age: 45-85 years old; 2) Diagnostic criteria for Western medicine: Previous history of coronary heart disease, NYHA cardiac function grading as II - III; 3) Diagnostic criteria for traditional Chinese medicine: Main symptoms: palpitations, shortness of breath, wheezing when moving, conscious fear of cold, and lukewarm hands and feet. Secondary symptoms: Little urine and swelling, bloating and loose stools, and a pale blue complexion. Tongue pulse: The tongue is light and plump or has tooth marks, and the pulse is thick and thin or late. 2 essential items for the main symptom and 2 items for the secondary symptom 4) Agree to participate in the trial, and be able to adhere to follow-up and seek medical treatment at the hospital on their own; 5) Sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1) Individuals with bronchial asthma, chronic bronchitis, pulmonary heart disease, and chronic obstructive pulmonary disease; 2) Individuals with unstable blood pressure control; 3) Acute cardiac insufficiency; 4) Severe liver and kidney dysfunction, as well as heart failure caused by important organ failure such as kidney and liver; (Note: Liver function (ALT, AST, TB) = 2 times the upper normal limit, or blood creatinine = 176umol/L, blood potassium = 5.5mmol/L.) 5) Those with severe primary diseases such as endocrine and hematopoietic systems; 6) Pregnant or lactating women; 7) Individuals with allergic constitution or a history of allergies; 8) Individuals with mental disorders and unwillingness to cooperate; Patients with poor compliance who interrupt treatment before the prescribed observation period and cannot determine the efficacy; 9) Those with poor adherence to the research process;

Design outcomes

Primary

MeasureTime frame
Cardiac ultrasound;6-minute walk test;

Secondary

MeasureTime frame
Clinical Symptom Score;Quality of life scores improved significantly;

Countries

China

Contacts

Public Contactliuzhaojie

Shanghai Jing'an District Shibei Hospital

liuzhaojie71@163.com+86 188 1738 5943

Outcome results

None listed

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