Anshen Buxin Liuwei Pills for the Treatment of Cardiac Neurosis

NCT04932395 | Unknown Phase 4 DMC

• 1 other identifier: ASBXLWW V2.0
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 7

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.

Conditions

Cardiac Neurosis

Outcome Measures

Primary Outcomes (1)

• 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).

  8 weeks

Secondary Outcomes (8)

• Cardiac autonomic nervous function

  Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks.

• Cardiac Neurosis Symptom Self-rating Scale

  Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks.

• Self-rating depression scale (SDS)

  Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks.

• Self-rating Anxiety Scale (SAS)

  Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks.

• Pittsburgh Sleep Scale Score

  Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks.

Study Arms (2)

Anshen Buxin Liuwei Pills

EXPERIMENTAL

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

Drug: Anshen Buxin Liuwei Pill

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Anshen Buxin Liuwei Pill DRUG

15 capsules/time, 2 times/day, orally.

Anshen Buxin Liuwei Pills

Placebo DRUG

Placebo simulated as the Anshen Buxin Liuwei Pills with same appearance，smell and taste,15 capsules/time, 2 times/day, orally.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Academy of Chinese Medical Sciences: lead
• Ministry of Science and Technology of the People´s Republic of China: collaborator
• Beijing University of Chinese Medicine: collaborator

Study Sites (7)

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100037, China

RECRUITING

Nanyang First People's Hospital

Nanyang, Henan, 473010, China

RECRUITING

The Third Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, 453000, China

RECRUITING

The First Hospital of Hunan University of Chinese Medicine

Changsha, Hunan, 410021, China

RECRUITING

Inner Mongolia International Mongolian Hospital

Hohhot, Inner Mongolia, 010010, China

RECRUITING

Kunshan First People's Hospital

Kunshan, Jiangsu, 215300, China

RECRUITING

The Second Affiliated Hospital of Shandong University of Chinese Medicine

Jinan, Shandong, 250001, China

WITHDRAWN

MeSH Terms

Conditions

Neurocirculatory Asthenia

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Central Study Contacts

Lihong Ma, Prof

CONTACT

13811695093; mlh8168@163.com

Yue Lan

CONTACT

13811695093; fuwaiyueyue@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 12, 2021
• First Posted: June 21, 2021
• Study Start: June 22, 2021
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: November 15, 2022

Record last verified: 2022-11

Locations

CN (7)