Anshen Buxin Liuwei Pills for the Treatment of Cardiac Neurosis
NCT ID: NCT04932395
Last Updated: 2022-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
400 participants
INTERVENTIONAL
2021-06-22
2024-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Anshen Buxin Liuwei Pills
15 pills/time, 2 times/day, orally，for 8 weeks
Anshen Buxin Liuwei Pill
15 capsules/time, 2 times/day, orally.
Placebo
15 pills/time, 2 times/day, orally. for 8 weeks
Placebo
Placebo simulated as the Anshen Buxin Liuwei Pills with same appearance，smell and taste,15 capsules/time, 2 times/day, orally.
Interventions
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Anshen Buxin Liuwei Pill
15 capsules/time, 2 times/day, orally.
Placebo
Placebo simulated as the Anshen Buxin Liuwei Pills with same appearance，smell and taste,15 capsules/time, 2 times/day, orally.
Eligibility Criteria
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Inclusion Criteria
* Meet the diagnostic criteria for cardiac neurosis: the patient has palpitations, precordial pain, chest tightness, shortness of breath, dyspnea, dizziness, insomnia and dreaminess, cold hands and feet, hyperhidrosis and other cardiovascular symptoms and neurological disorders;
* Meet the diagnostic criteria of Heyisheng type palpitations in Mongolian medicine;
* There is no objective diagnosis of coronary heart disease (in accordance with any of the following): ①The activity flat test is negative; ② Coronary angiography or coronary CTA suggests that the lumen stenosis is ≤50%; ③ Exercise or drug load radionuclide examination results suggest no myocardial ischemia;
* The patient did not take anti-anxiety and depression drugs or psychotropic drugs within 2 weeks before enrollment;
* agrees to voluntarily participate in the study and signs an informed consent form .
Exclusion Criteria
* Poor hypertension control (systolic blood pressure ≥160mmHg or diastolic blood pressure ≥100mmHg after treatment);
* Those with malignant arrhythmia;
* Those who use pacemakers;
* Patients with hyperthyroidism;
* Combined with severe liver and kidney damage (ALT, AST or TBIL\> 2 times the upper limit of the normal reference value, or Cr\> 1.5 times the upper limit of the normal reference value);
* People with serious primary diseases such as hematopoietic system or mental illness;
* SAS≥70;
* SDS≥73;
* Accompanying any other serious diseases or conditions such as malignant tumors;
* Women during pregnancy and lactation;
* People with allergies or allergies to the known ingredients of the research drug;
* Participated in other clinical research in the past 3 months;
* According to the judgment of the investigator, the subject is not suitable for research observation.
18 Years
75 Years
ALL
No
Sponsors
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Ministry of Science and Technology of the People´s Republic of China
OTHER_GOV
Beijing University of Chinese Medicine
OTHER
China Academy of Chinese Medical Sciences
OTHER
Responsible Party
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Zhong Wang
Professor
Locations
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Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Nanyang First People's Hospital
Nanyang, Henan, China
The Third Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
The First Hospital of Hunan University of Chinese Medicine
Changsha, Hunan, China
Inner Mongolia International Mongolian Hospital
Hohhot, Inner Mongolia, China
Kunshan First People's Hospital
Kunshan, Jiangsu, China
The Second Affiliated Hospital of Shandong University of Chinese Medicine
Jinan, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ASBXLWW V2.0
Identifier Type: -
Identifier Source: org_study_id
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