This study aims to assess the effect and safety of the traditional Mongolian medicine Anshen Buxin Liuwei Pill for the treatment of cardiac neurosis.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
400
15 capsules/time, 2 times/day, orally.
Placebo simulated as the Anshen Buxin Liuwei Pills with same appearance,smell and taste,15 capsules/time, 2 times/day, orally.
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGNanyang First People's Hospital
Nanyang, Henan, China
RECRUITINGThe Third Affiliated Hospital of Xinxiang Medical University
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).
Time frame: 8 weeks
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.
Time frame: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks.
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
Time frame: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks.
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).
Time frame: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks.
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Xinxiang, Henan, China
The First Hospital of Hunan University of Chinese Medicine
Changsha, Hunan, China
RECRUITINGInner Mongolia International Mongolian Hospital
Hohhot, Inner Mongolia, China
RECRUITINGKunshan First People's Hospital
Kunshan, Jiangsu, China
RECRUITINGThe Second Affiliated Hospital of Shandong University of Chinese Medicine
Jinan, Shandong, China
WITHDRAWNSelf-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.
Time frame: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks.
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.
Time frame: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks.
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
Time frame: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks.
hypersensitive C-reactive protein (hs-CRP)
hs-CRP is used to evaluate the level of systemic inflammation in the patients with cardiac neurosis.
Time frame: Baseline, 4 weeks, 8 weeks
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.
Time frame: Baseline, 4 weeks, 8 weeks