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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Evidence-Based Evaluation Study of Xinkang Capsules for the Treatment of Chronic Heart Failure (Preserved Ejection Fraction) in Inner Mongolia

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Evidence-Based Evaluation Study of Xinkang Capsules for the Treatment of Chronic Heart Failure (Preserved Ejection Fraction) in Inner Mongolia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113036
Enrollment
Unknown
Registered
2025-11-24
Start date
2025-12-31
Completion date
Unknown
Last updated
2025-12-01

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

Conditions

Chronic heart failure (preserved ejection fraction)

Interventions

Treatment group of Xinshuaikang:Xin shuaiukang Capsules + Conventional Western Medication Therapy
Control group of placebo:Placebo + Conventional Western Medication Therapy

Sponsors

Inner Mongolia Autonomous Region Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Based on medical history, physical signs, clinical manifestations, and relevant auxiliary examinations, subjects meeting the following criteria may be included in this trial: (1) Meet both Western medical diagnostic criteria and Traditional Chinese Medicine (TCM) syndrome diagnostic criteria; (2) Aged 18–80 years, no gender restrictions; (3) NYHA heart function classification stage II–III; (4) Native Inner Mongolians residing in the region for 1 year or longer; (5) No participation in related chronic heart failure clinical trials within the past 3 months; (6) Relatively stable condition with consistent adherence to medications for underlying conditions; (7) Full understanding of the study protocol, informed consent obtained, and signed informed consent form.

Exclusion criteria

Exclusion criteria: (1) Acute heart failure; (2) History of ventricular fibrillation or sustained ventricular tachycardia; (3) Concurrent benign or malignant tumors, infections, hepatic or renal insufficiency, severe anemia, hematologic disorders including coagulation disorders, cerebrovascular or respiratory diseases; (4) Psychiatric disorders or poor treatment compliance, non-cooperation with study protocols; (5) Heart failure caused by failure of major organs; (6) History of allergy to the study drug; (7) Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
NYHA classification of cardiac function;Traditional Chinese Medicine Syndrome Scoring Scale;Left Ventricular Ejection Fractions;NT-proBNP;Six minutes walk test;

Countries

China

Contacts

Public ContactJing Zhang

Inner Mongolia Autonomous Region Hospital of Traditional Chinese Medicine

1531959230@qq.com+86 136 2481 8399

Outcome results

None listed

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