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Adaptive enrichment, multicentre, randomized, double-blind, placebo-controlled clinical trial of Anshen Buxin Liuwei Pill in the treatment of cardiac neurosis (Heyisheng type palpitation)

Adaptive enrichment, multicentre, randomized, double-blind, placebo-controlled clinical trial of Anshen Buxin Liuwei Pill in the treatment of cardiac neurosis (Heyisheng type palpitation)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100004585
Enrollment
Unknown
Registered
2021-03-18
Start date
2021-04-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Cardiac neurosis (Hessian palpitations)

Interventions

Sponsors

Fuwai Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 and <=75 years; 2. It meets the diagnostic criteria of cardiac neurosis: the patient has heart palpitations, precardiac pain, chest shortness of breath, dyspnea, dizziness, insomnia and dreaminess, hand and foot chills, sweating and other cardiovascular symptoms and neurological disorders; 3. It meets the diagnostic criteria of Mongolian medicine Heyisheng type palpitation; 4. No objective basis for the diagnosis of CHD (conforms to any of the following); (1) The movable plate test was negative; (2) Coronary angiography or coronary CTA indicated lumen stenosis <= 50%; (3) No myocardial ischemia was found by exercise or drug stress radionuclide examination. 5. Patients did not take anti-anxiety and depression drugs or psychotropic drugs within 2 weeks before enrollment; 6. Signed the informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients with organic heart disease and severe cardiopulmonary insufficiency; (2) Poor hypertension control (post-treatment systolic blood pressure >= 160mmHg or diastolic blood pressure >= 100mmHg); (3) Patients with malignant arrhythmia; (4) Patients with cardiac pacemakers; (5) Patients with hyperthyroidism; (6) Severe hepatic and renal function impairment (ALT, AST or TBIL>2 times the upper normal reference value, or CR BBB>5 times the upper normal reference value); (7) Complicated with hematopoietic system and other serious primary diseases, mental illness; (8) SAS >= 70 points; (9) SDS >= 73 points; (10) Accompanied by any other serious disease or condition such as: malignant tumor; (11) Women in pregnancy or lactating period; (12) People with allergies or allergies to known ingredients of the study drug; (13) Participated in other clinical researchers within the last 3 months; (14) In the Investigator's judgment, the subjects were unsuitable for study observation.

Design outcomes

Primary

MeasureTime frame
At week 8, the proportion of patients with Heyshin type palpitation symptoms improved in Mongolian medicine;

Secondary

MeasureTime frame
SAS;Pittsburgh Sleep Scale score;Poor standing heart rate;serotonin;The frequency and dosage of the sedative and hypnotic drug serazepam;hs-crp;Incidence of adverse drug events and serious adverse events;SDS;Scores of the Evaluation Scale for the Symptom Classification of Heart Palpitations in Mongolian Medicine;Self-Rating Cardiac Neurosis Symptoms Scale ;

Countries

China

Contacts

Public ContactLan Yue

Fuwai Hospital, Chinese Academy of Medical Sciences

fuwaiyueyue@163.com+86 13811695093

Outcome results

None listed

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