Cardiac NeurosisPhase 4NCT04932395
Anshen Buxin Liuwei Pills for the Treatment of Cardiac Neurosis
A Phase 4 study testing Anshen Buxin Liuwei Pill in people with Cardiac Neurosis, run by China Academy of Chinese Medical Sciences at 7 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiac Neurosis
- What is being tested?
- Anshen Buxin Liuwei Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 7 sitesChina
- Study dates
- 22 Jun 2021to 1 Jun 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 .
Who cannot join
- 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);
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- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites, 6 recruiting
- Recruiting
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100037
Lihong Ma, Prof., 13811695093, mlh8168@163.com
Yue Lan, 13811695093, fuwaiyueyue@163.com
- Recruiting
The First Hospital of Hunan University of Chinese Medicine
Changsha, Hunan, 410021
Jianhe Liu, Prof., 17343602090, ljhm1@163.com
- Recruiting
Inner Mongolia International Mongolian Hospital
Hohhot, Inner Mongolia, 010010
Dalai Nashun, M.D., 13848913897, 1045321506@qq.com
- Withdrawn
The Second Affiliated Hospital of Shandong University of Chinese Medicine
Jinan, Shandong, 250001
- Recruiting
Kunshan First People's Hospital
Kunshan, Jiangsu, 215300
Haojun Xu, master, 0512-57530744, 15062680097@163.com
- Recruiting
Nanyang First People's Hospital
Nanyang, Henan, 473010
Jinxia Ma, Prof, 0377-63310089, nysgcp@163.com
- Recruiting
The Third Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, 453000
Guotian Yin, Prof, 0373-3029611, xysfygcp@163.com
About this study
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
This study aims to assess the effect and safety of the traditional Mongolian medicine Anshen Buxin Liuwei Pill for the treatment of cardiac neurosis.
Read the 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.
- Conditions
- Cardiac Neurosis
- Being tested
- Anshen Buxin Liuwei Pill, Placebo
- Medical subject headings
- Neurocirculatory Asthenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anshen Buxin Liuwei PillDrug
15 capsules/time, 2 times/day, orally.
PlaceboDrug
Placebo simulated as the Anshen Buxin Liuwei Pills with same appearance，smell and taste,15 capsules/time, 2 times/day, orally.
| Study group | Role | What they receive |
|---|---|---|
| Anshen Buxin Liuwei Pills | Experimental | 15 pills/time, 2 times/day, orally，for 8 weeks Receives: Drug: Anshen Buxin Liuwei Pill |
| Placebo | Placebo comparator | 15 pills/time, 2 times/day, orally. for 8 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 8 weeks
Secondary outcomes (8)
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.
Measured: 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
Measured: 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).
Measured: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks.
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Baseline, 4 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start22 Jun 2021
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac NeurosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology of the People´s Republic of China, Beijing University of Chinese Medicine
- Responsible party
- Principal investigator, Zhong Wang, China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04932395
- Sponsor's protocol ID
- ASBXLWW V2.0
- Status last verified
- Nov 2022
- First submitted
- 12 Jun 2021
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04932395
- Acronym / sponsor ID
- ASBXLWW V2.0
- Conditions
- Cardiac Neurosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology of the People´s Republic of China, Beijing University of Chinese Medicine
- Study start
- 22 Jun 2021 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 21 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anshen Buxin Liuwei Pills | Experimental | Drug: Anshen Buxin Liuwei Pill15 pills/time, 2 times/day, orally，for 8 weeks |
| Placebo | Placebo comparator | Drug: Placebo15 pills/time, 2 times/day, orally. for 8 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anshen Buxin Liuwei Pill15 capsules/time, 2 times/day, orally. | Drug | Anshen Buxin Liuwei Pills |
| PlaceboPlacebo simulated as the Anshen Buxin Liuwei Pills with same appearance，smell and taste,15 capsules/time, 2 times/day, orally. | Drug | Placebo |
Primary outcome
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 secondary outcomes
Cardiac autonomic nervous function
Time frame: 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.
Self-rating depression scale (SDS)
Time frame: 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.
Pittsburgh Sleep Scale Score
Time frame: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks.
Consumption of estazolam
Time frame: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks.
hypersensitive C-reactive protein (hs-CRP)
Time frame: Baseline, 4 weeks, 8 weeks
The level of serotonin
Time frame: Baseline, 4 weeks, 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Anshen Buxin Liuwei Pill in people with Cardiac Neurosis, run by China Academy of Chinese Medical Sciences at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lihong Ma, Prof (13811695093, mlh8168@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Palpitation with Heyisheng Type Symptoms Scale in Mongolian Medicine (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022.