Last updated: November 13, 2022
Sponsor: China Academy of Chinese Medical Sciences
Overall Status: Active - Recruiting
Phase
4
Condition
Somatoform And Dissociative Disorders
Treatment
N/AClinical Study ID
NCT04932395
ASBXLWW V2.0
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age ≥18 years old, ≤75 years old;
- Meet the diagnostic criteria for cardiac neurosis: the patient has palpitations,precordial pain, chest tightness, shortness of breath, dyspnea, dizziness, insomniaand dreaminess, cold hands and feet, hyperhidrosis and other cardiovascular symptomsand 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 ofthe following): ①The activity flat test is negative; ② Coronary angiography orcoronary CTA suggests that the lumen stenosis is ≤50%; ③ Exercise or drug loadradionuclide examination results suggest no myocardial ischemia;
- The patient did not take anti-anxiety and depression drugs or psychotropic drugswithin 2 weeks before enrollment;
- agrees to voluntarily participate in the study and signs an informed consent form .
Exclusion
Exclusion Criteria:
- Accompanied by organic heart disease, severe cardiopulmonary insufficiency;
- Poor hypertension control (systolic blood pressure ≥160mmHg or diastolic bloodpressure ≥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 upperlimit of the normal reference value, or Cr> 1.5 times the upper limit of the normalreference 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 forresearch observation.
Study Design
Total Participants: 400
Study Start date:
June 22, 2021
Estimated Completion Date:
June 01, 2024
Study Description
Connect with a study center
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing 100037
ChinaActive - Recruiting
Nanyang First People's Hospital
Nanyang, Henan 473010
ChinaActive - Recruiting
The Third Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan 453000
ChinaActive - Recruiting
The First Hospital of Hunan University of Chinese Medicine
Changsha, Hunan 410021
ChinaActive - Recruiting
Inner Mongolia International Mongolian Hospital
Hohhot, Inner Mongolia 010010
ChinaActive - Recruiting
Kunshan First People's Hospital
Kunshan, Jiangsu 215300
ChinaActive - Recruiting
The Second Affiliated Hospital of Shandong University of Chinese Medicine
Jinan, Shandong 250001
ChinaSite Not Available
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