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Study protocol for the efficacy and safety of Ge Xin Tong Intervention in patients with Chronic CAD and related diseases based on community population-a prospective real-world study

Study protocol for the efficacy and safety of Ge Xin Tong Intervention in patients with Chronic CAD and related diseases based on community population-a prospective real-world study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100044361
Enrollment
Unknown
Registered
2021-03-17
Start date
2021-04-01
Completion date
Unknown
Last updated
2021-09-07

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

Conditions

Chronic CAD and related diseases

Interventions

Two groups:Take "Ge Xin Tong" at the effective dose

Sponsors

Youyi Clinical Laboratories of Shaanxi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Arterial plaque formation: (1) Cervical ultrasound: arterial intimal thickening (IMT > = 0.9 mm) (more than 1.2 mm indicates plaque formation), or atheromatous plaque formation; (2) hyperlipidemia: plasma TG and/or TC increased, or LDL-C increased and HDL-C decreased; (3) hypertension clinical diseases, such as cardiovascular and cerebrovascular diseases, diabetes, impaired renal function, peripheral vascular disease, retinopathy, etc.; (4) risk factor behavior: smoking or passive smoking, abdominal obesity, obesity, older than 45 years, high-salt diet; (5) aged 18-70 years. Necessary conditions for inclusion in the study: (1) and (2); and (2) or (3) or (4). 2. People with chronic diseases: (1) diagnosed as one of the following chronic diseases and lasting for more than 3 months: CAD (various cardiovascular diseases), diabetes and prediabetes (glycation > = 6.1% or impaired glucose tolerance), hypertension (systolic/diastolic blood pressure: 140/90), hyperlipidemia (plasma TG and/or TC increased, or LDL-C increased and HDL-C decreased), overweight (BMI > = 24); (2) the above diseases need to be controlled with drugs, and medication compliance is good; (3) no adverse drug reactions; (4) no history of serious adverse cardiovascular events in the past 6 months; (5) aged 18-70 years.

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactating women; 2. Patients with mental illness and malignant tumors; 3. Patients taking antibiotics, Chinese patent medicines or allergic to Chinese herbal medicines in the study; 4. Patients with severe digestive, respiratory, liver and kidney and endocrine diseases; 5. Patients with palpitations and tachycardia.

Design outcomes

Primary

MeasureTime frame
imaging test;Blood biochemistry test;Chronic disease examination;

Countries

China

Contacts

Public ContactChen Sha

Youyi Clinical Laboratories of Shaanxi

36759468@qq.com+86 13572946016

Outcome results

None listed

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