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Anshen Buxin Liuwei Pills for the Treatment of Cardiac Neurosis

Primary Purpose

Cardiac Neurosis

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Anshen Buxin Liuwei Pill
Placebo
Sponsored by
China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Neurosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fuwai Hospital, Chinese Academy of Medical SciencesRecruiting
  • Nanyang First People's HospitalRecruiting
  • The Third Affiliated Hospital of Xinxiang Medical UniversityRecruiting
  • The First Hospital of Hunan University of Chinese MedicineRecruiting
  • Inner Mongolia International Mongolian HospitalRecruiting
  • Kunshan First People's HospitalRecruiting
  • The Second Affiliated Hospital of Shandong University of Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Anshen Buxin Liuwei Pills

Placebo

Arm Description

15 pills/time, 2 times/day, orally，for 8 weeks

15 pills/time, 2 times/day, orally. for 8 weeks

Outcomes

Primary Outcome Measures

Palpitation with Heyisheng Type Symptoms Scale in Mongolian Medicine
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).

Secondary Outcome Measures

Cardiac autonomic nervous function
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.
Cardiac Neurosis Symptom Self-rating Scale
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
Self-rating depression scale (SDS)
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).
Self-rating Anxiety Scale (SAS)
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.
Pittsburgh Sleep Scale Score
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.
Consumption of estazolam
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
hypersensitive C-reactive protein (hs-CRP)
hs-CRP is used to evaluate the level of systemic inflammation in the patients with cardiac neurosis.
The level of serotonin
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.

Full Information

First Posted
June 12, 2021
Last Updated
November 13, 2022
Sponsor
China Academy of Chinese Medical Sciences
Collaborators
Ministry of Science and Technology of the People's Republic of China, Beijing University of Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04932395
Brief Title
Anshen Buxin Liuwei Pills for the Treatment of Cardiac Neurosis
Official Title
An Adaptive Enrichment Designed, Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial of Anshen Buxin Liuwei Pills in the Treatment of Cardiac Neurosis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 22, 2021 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Academy of Chinese Medical Sciences
Collaborators
Ministry of Science and Technology of the People's Republic of China, Beijing University of Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Neurosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anshen Buxin Liuwei Pills
Arm Type
Experimental
Arm Description
15 pills/time, 2 times/day, orally，for 8 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
15 pills/time, 2 times/day, orally. for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Anshen Buxin Liuwei Pill
Intervention Description
15 capsules/time, 2 times/day, orally.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo simulated as the Anshen Buxin Liuwei Pills with same appearance，smell and taste,15 capsules/time, 2 times/day, orally.
Primary Outcome Measure Information:
Title
Palpitation with Heyisheng Type Symptoms Scale in Mongolian Medicine
Description
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).
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Cardiac autonomic nervous function
Description
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.
Time Frame
Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks.
Title
Cardiac Neurosis Symptom Self-rating Scale
Description
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
Time Frame
Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks.
Title
Self-rating depression scale (SDS)
Description
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).
Time Frame
Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks.
Title
Self-rating Anxiety Scale (SAS)
Description
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.
Time Frame
Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks.
Title
Pittsburgh Sleep Scale Score
Description
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.
Time Frame
Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks.
Title
Consumption of estazolam
Description
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
Time Frame
Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks.
Title
hypersensitive C-reactive protein (hs-CRP)
Description
hs-CRP is used to evaluate the level of systemic inflammation in the patients with cardiac neurosis.
Time Frame
Baseline, 4 weeks, 8 weeks
Title
The level of serotonin
Description
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.
Time Frame
Baseline, 4 weeks, 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lihong Ma, Prof
Phone
13811695093
Email
mlh8168@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yue Lan
Phone
13811695093
Email
fuwaiyueyue@163.com
Facility Information:
Facility Name
Fuwai Hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100037
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lihong Ma, Prof.
Phone
13811695093
Email
mlh8168@163.com
First Name & Middle Initial & Last Name & Degree
Yue Lan
Phone
13811695093
Email
fuwaiyueyue@163.com
Facility Name
Nanyang First People's Hospital
City
Nanyang
State/Province
Henan
ZIP/Postal Code
473010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinxia Ma, Prof
Phone
0377-63310089
Email
nysgcp@163.com
Facility Name
The Third Affiliated Hospital of Xinxiang Medical University
City
Xinxiang
State/Province
Henan
ZIP/Postal Code
453000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guotian Yin, Prof
Phone
0373-3029611
Email
xysfygcp@163.com
Facility Name
The First Hospital of Hunan University of Chinese Medicine
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianhe Liu, Prof.
Phone
17343602090
Email
ljhm1@163.com
Facility Name
Inner Mongolia International Mongolian Hospital
City
Hohhot
State/Province
Inner Mongolia
ZIP/Postal Code
010010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dalai Nashun, M.D.
Phone
13848913897
Email
1045321506@qq.com
Facility Name
Kunshan First People's Hospital
City
Kunshan
State/Province
Jiangsu
ZIP/Postal Code
215300
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haojun Xu, master
Phone
0512-57530744
Email
15062680097@163.com
Facility Name
The Second Affiliated Hospital of Shandong University of Chinese Medicine
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250001
Country
China
Individual Site Status
Withdrawn

12. IPD Sharing Statement

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Anshen Buxin Liuwei Pills for the Treatment of Cardiac Neurosis

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