Anshen Buxin Liuwei Pills for the Treatment of Cardiac Neurosis

November 13, 2022 updated by: Zhong Wang, China Academy of Chinese Medical Sciences

An Adaptive Enrichment Designed, Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial of Anshen Buxin Liuwei Pills in the Treatment of Cardiac Neurosis

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100037
        • Recruiting
        • Fuwai Hospital, Chinese Academy of Medical Sciences
        • Contact:
        • Contact:
    • Henan
      • Nanyang, Henan, China, 473010
        • Recruiting
        • Nanyang First People's Hospital
        • Contact:
      • Xinxiang, Henan, China, 453000
        • Recruiting
        • The Third Affiliated Hospital of Xinxiang Medical University
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410021
        • Recruiting
        • The First Hospital of Hunan University of Chinese Medicine
        • Contact:
          • Jianhe Liu, Prof.
          • Phone Number: 17343602090
          • Email: ljhm1@163.com
    • Inner Mongolia
      • Hohhot, Inner Mongolia, China, 010010
        • Recruiting
        • Inner Mongolia International Mongolian Hospital
        • Contact:
    • Jiangsu
      • Kunshan, Jiangsu, China, 215300
        • Recruiting
        • Kunshan First People's Hospital
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250001
        • Withdrawn
        • The Second Affiliated Hospital of Shandong University of Chinese Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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, 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:

  • Accompanied by organic heart disease, severe cardiopulmonary insufficiency;
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anshen Buxin Liuwei Pills
15 pills/time, 2 times/day, orally，for 8 weeks
Drug: Anshen Buxin Liuwei Pill
15 capsules/time, 2 times/day, orally.
Placebo Comparator: Placebo
15 pills/time, 2 times/day, orally. for 8 weeks
Drug: Placebo
Placebo simulated as the Anshen Buxin Liuwei Pills with same appearance，smell and taste,15 capsules/time, 2 times/day, orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Palpitation with Heyisheng Type Symptoms Scale in Mongolian Medicine
Time Frame: 8 weeks
The scale is to record the symptoms of palpitation with Heyisheng Type in Mongolian Medicine, which is also usually seen in cardiac neurosis. This scale includes two domain: the primary symptoms and the secondary symptoms. The domain of the primary symptoms includes palpitations, chest tightness, chest pain, insomnia, and restlessness using the evaluating 4-Grade scales (Normal:0; Mild:3; Moderate:6 and Severe:9), while the domain of the secondary symptoms includes dizziness, like to sigh, easy to startle, tinnitus, blurred vision, fatigue, sweating, irritability, using the evaluating 4-Grade scales (Normal:0; Mild:1; Moderate:2 and Severe:3).
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac autonomic nervous function
Time Frame: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks.
The cardiac autonomic nervous function was evaluated by detecting the difference in heart rate per minute between standing and lying positions using RR interval in lead Ⅱ ECG.
Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks.
Cardiac Neurosis Symptom Self-rating Scale
Time Frame: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks.
This self-rating scale was used to evaluate the main symptoms in cardiac neurosis, including palpitations, chest tightness, chest pain, hyperhidrosis, insomnia, irritability, with each symptom evaluated via a 4-grading scale (normal:0 points, mild: 1 point, moderate: 2 points, severe:3 points
Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks.
Self-rating depression scale (SDS)
Time Frame: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks.
The Self-Rating Depression Scale (SDS) which was designed by Zung was adopted to assess participants' symptoms of depression during the past week. The SDS assesses depressive symptoms on a four-point scale ranging from "a little of the time" (value = 1) to "most of the time" (value = 4). The standard score is equal to the integer portion of 1.25 times the total score. The standard score of SDS is interpreted as: normal (≤52), mild (53-62), moderate (63-72), and severe (≥73).
Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks.
Self-rating Anxiety Scale (SAS)
Time Frame: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks.
The SAS is a 20-item measure developed to assess the frequency of anxiety symptoms based on diagnostic conceptualizations. It consists primarily of somatic symptoms. The respondent indicates how often he or she has experienced each symptom on a 4-point Likert scale consisting of "one or a little of the time" (coded as 1), "some of the time" (coded as 2), "good part of the time" (coded as 3), and "most or all of the time" (coded as 4). Items 5, 9, 13, 16, and 19 are reversed scored and total scores on the SAS range from 0 to 80.
Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks.
Pittsburgh Sleep Scale Score
Time Frame: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks.
The PSQI comprises 19 self-evaluation items, among which 18 items generate 7 components. Each component is graded from 0 to 3, and the cumulative score of each component is the total score of PSQI, which ranges from 0 to 21.
Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks.
Consumption of estazolam
Time Frame: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks.
If the patient has a moderate or above anxiety and depression state and is intolerable, he could be given a short-term sedative and hypnotic drug,estazolam, and the frequency and dose of estazolam should be recorded in the patient's diary
Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks.
hypersensitive C-reactive protein (hs-CRP)
Time Frame: Baseline, 4 weeks, 8 weeks
hs-CRP is used to evaluate the level of systemic inflammation in the patients with cardiac neurosis.
Baseline, 4 weeks, 8 weeks
The level of serotonin
Time Frame: Baseline, 4 weeks, 8 weeks
The decrease of serotonin is reported in the patients with cardiac neurosis. The level of serotonin could be used to evaluate the effect for cardiac neurosis.
Baseline, 4 weeks, 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Academy of Chinese Medical Sciences

Collaborators

Beijing University of Chinese Medicine
Ministry of Science and Technology of the People's Republic of China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2021

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

June 12, 2021

First Submitted That Met QC Criteria

June 12, 2021

First Posted (Actual)

June 21, 2021

Study Record Updates

Last Update Posted (Actual)

November 15, 2022

Last Update Submitted That Met QC Criteria

November 13, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASBXLWW V2.0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiac Neurosis

Clinical Trials on Anshen Buxin Liuwei Pill

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guatemala

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe