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The Efficacy of Modified Huanglian Wendan Decoction for Patients with Phlegm-Heat Type Coronary Heart Diseasewith Insomnia : a Randomized Controlled Trial

The Efficacy of Modified Huanglian Wendan Decoction for Patients with Phlegm-Heat Type Coronary Heart Diseasewith Insomnia : a Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000499
Enrollment
Unknown
Registered
2025-03-10
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Coronary heart disease with insomnia

Interventions

treatment group:Basic treatment combined with Huanglian Wendan decoction
control group:Basic treatment

Sponsors

The Affiliated Traditional Chinese Medicine Hospital Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Age 40-70 years old (including 40 years old and 70 years old) regardless of gender; (2) consistent with the western medicine diagnostic criteria of stable angina pectoris of coronary heart disease CCS grade ?-?; (3) Conforming to the syndrome differentiation diagnostic criteria of chest stuffiness heartache phlegm-heat type; (4) meet the diagnostic criteria of insomnia of traditional Chinese and western medicine PSQI score > 7; (5) not taking relevant traditional Chinese medicine and sedative and hypnotic drugs in the two weeks before enrollment; (6) Able to complete the informed consent form and questionnaire and actively cooperate with the researchers.

Exclusion criteria

Exclusion criteria: (1) patients with severe hypertension severe cardiopulmonary insufficiency severe arrhythmia severe primary diseases of liver kidney hematopoietic system and mental illness; (2) insomnia patients with severe anxiety and depression; (3) patients with malignant diseases (such as malignant tumors); (4) menstruating ovulatory pregnant or lactating women; (5) patients with allergic constitution or allergy to multiple drugs; (6) Investigators who participated in other clinical trials in the past 1 month.

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index Scale;Seattle Angina Scale;

Secondary

MeasureTime frame
Electrocardiography;Reduction rate of nitroglycerin;TCM syndrome score;

Countries

China

Contacts

Public ContactDongxiong Chen

The Affiliated Traditional Chinese Medicine Hospital Guangzhou Medical University

327333319@qq.com+86 183 1205 9047

Outcome results

None listed

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