Anshen Buxin Liuwei Pills for the Treatment of Cardiac Neurosis

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/A

Clinical Study ID

NCT04932395
ASBXLWW V2.0
  • Ages 18-75
  • All Genders

Study Summary

This study aims to assess the effect and safety of the traditional Mongolian medicine Anshen Buxin Liuwei Pill for the treatment of cardiac neurosis.

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

Cardiac neurosis is a group of symptoms characterized by the coexistence of cardiovascular disease related symptoms and nervous system disorders. Anshen Buxin Liuwei Pill is a kind of traditional Mongolian medicine for the treatment of cardiac neurosis. This study aims to evaluate the effect and safety of Anshen Buxin Liuwei Pill for cardiac neurosis in a prospective, randomized, double-blind, placebo-controlled clinical trial.

Connect with a study center

  • Fuwai Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing 100037
    China

    Active - Recruiting

  • Nanyang First People's Hospital

    Nanyang, Henan 473010
    China

    Active - Recruiting

  • The Third Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan 453000
    China

    Active - Recruiting

  • The First Hospital of Hunan University of Chinese Medicine

    Changsha, Hunan 410021
    China

    Active - Recruiting

  • Inner Mongolia International Mongolian Hospital

    Hohhot, Inner Mongolia 010010
    China

    Active - Recruiting

  • Kunshan First People's Hospital

    Kunshan, Jiangsu 215300
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Shandong University of Chinese Medicine

    Jinan, Shandong 250001
    China

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.