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出境医 / 临床实验 / Retrospective Clinical Study on Adjuvant Treatment of Coronary Heart Disease Angina Pectoris With Chinese Patent Medicine (RCSCD-TCM)

Retrospective Clinical Study on Adjuvant Treatment of Coronary Heart Disease Angina Pectoris With Chinese Patent Medicine (RCSCD-TCM)

Study Description
Brief Summary:
A retrospective cohort study was performed in patients with angina pectoris who were treated with oral Chinese patent medicine and Western medicine.The hospital's medical record management system was used to collect symptoms of angina pectoris, dose and frequency of nitroglycerin use, clinical biochemical test and imaging examination.To explore the clinical efficacy of Chinese patent medicine in the treatment of coronary heart disease with angina pectoris, and provide reliable data support for its clinical application.

Condition or disease Intervention/treatment
Atherosclerotic Heart Disease With Angina Nos Drug: Chinese patent medicine

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 12400 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Cohort Study on Adjuvant Treatment of Coronary Heart Disease Angina Pectoris With Chinese Patent Medicine
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : September 1, 2020
Arms and Interventions
Group/Cohort Intervention/treatment
Exposed group
Chinese patent medicine combined with western medicine routine treatment
 Drug: Chinese patent medicine
Shexiang Baoxin Pill, Tongxinluo Capsule, Tongmai Yangxin Pill, Xuefu Zhuyu Capsule, Qishen Yiqi Dropping Pill.
Non-exposed group
Western medicine routine treatment
Outcome Measures
Primary Outcome Measures :
  1. Symptoms of angina [ Time Frame: one year ]
  2. Dosage and frequency of use of nitroglycerin [ Time Frame: one year ]
  3. Clinical biochemical indicators test [ Time Frame: one year ]
  4. Film degree exam [ Time Frame: one year ]

Eligibility Criteria
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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
The collaboration network of coronary heart disease research medical units formed by the research group, including the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, the Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin Nankai Hospital, Tianjin Chest Hospital, Tianjin Medical University General Hospital, a total of 5 hospitals.
Criteria

Inclusion Criteria:

  1. Age 35-75 years old, gender is not limited;
  2. Admission time is September 1, 2014 - September 1, 1919;
  3. Patients with coronary heart disease and angina pectoris in the Department of Cardiology or Outpatient Department, the diagnosis of angina pectoris meets the diagnostic criteria of Western medicine and the standard of TCM syndrome differentiation;
  4. Patients who met the criteria for drug treatment, the exposed group was treated with traditional Chinese medicine combined with Western medicine, and the non-exposed group was treated with Western medicine alone.

Exclusion Criteria:

  1. Combined with other heart diseases, neurosis, menopausal syndrome, hyperthyroidism, cervical or vertebral artery type cervical spondylosis, gastro-oesophageal reflux disease or esophageal hiatus hernia may cause chest pain;
  2. patients with acute myocardial infarction, heart failure, myocarditis, cardiomyopathy, severe heart valve disease, liver failure or renal failure, malignant tumors and severe metabolic diseases, as well as patients with severe symptoms and uncontrollable angina;
  3. Pregnant women, lactating women or women of childbearing age who have birth requirements;
  4. Mental patients, or cognitive dysfunction;
  5. The investigator believes that there are other situations that are not suitable for the trial.
Contacts and Locations

Locations
Layout table for location information
China, Tianjin
Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin, China, 300193
Contact: Chunquan Yu, Dr.    8622-59596309    ycq-4@163.com   
Sponsors and Collaborators
Tianjin University of Traditional Chinese Medicine
Tracking Information
First Submitted Date July 13, 2019
First Posted Date July 19, 2019
Last Update Posted Date July 22, 2019
Estimated Study Start Date September 1, 2019
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 18, 2019)
  • Symptoms of angina [ Time Frame: one year ]
  • Dosage and frequency of use of nitroglycerin [ Time Frame: one year ]
  • Clinical biochemical indicators test [ Time Frame: one year ]
  • Film degree exam [ Time Frame: one year ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Retrospective Clinical Study on Adjuvant Treatment of Coronary Heart Disease Angina Pectoris With Chinese Patent Medicine
Official Title Retrospective Cohort Study on Adjuvant Treatment of Coronary Heart Disease Angina Pectoris With Chinese Patent Medicine
Brief Summary A retrospective cohort study was performed in patients with angina pectoris who were treated with oral Chinese patent medicine and Western medicine.The hospital's medical record management system was used to collect symptoms of angina pectoris, dose and frequency of nitroglycerin use, clinical biochemical test and imaging examination.To explore the clinical efficacy of Chinese patent medicine in the treatment of coronary heart disease with angina pectoris, and provide reliable data support for its clinical application.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The collaboration network of coronary heart disease research medical units formed by the research group, including the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, the Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin Nankai Hospital, Tianjin Chest Hospital, Tianjin Medical University General Hospital, a total of 5 hospitals.
Condition Atherosclerotic Heart Disease With Angina Nos
Intervention Drug: Chinese patent medicine
Shexiang Baoxin Pill, Tongxinluo Capsule, Tongmai Yangxin Pill, Xuefu Zhuyu Capsule, Qishen Yiqi Dropping Pill.
Study Groups/Cohorts
  • Exposed group
    Chinese patent medicine combined with western medicine routine treatment
    Intervention: Drug: Chinese patent medicine
  • Non-exposed group
    Western medicine routine treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: July 18, 2019) 		12400
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 1, 2020
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Age 35-75 years old, gender is not limited;
  2. Admission time is September 1, 2014 - September 1, 1919;
  3. Patients with coronary heart disease and angina pectoris in the Department of Cardiology or Outpatient Department, the diagnosis of angina pectoris meets the diagnostic criteria of Western medicine and the standard of TCM syndrome differentiation;
  4. Patients who met the criteria for drug treatment, the exposed group was treated with traditional Chinese medicine combined with Western medicine, and the non-exposed group was treated with Western medicine alone.

Exclusion Criteria:

  1. Combined with other heart diseases, neurosis, menopausal syndrome, hyperthyroidism, cervical or vertebral artery type cervical spondylosis, gastro-oesophageal reflux disease or esophageal hiatus hernia may cause chest pain;
  2. patients with acute myocardial infarction, heart failure, myocarditis, cardiomyopathy, severe heart valve disease, liver failure or renal failure, malignant tumors and severe metabolic diseases, as well as patients with severe symptoms and uncontrollable angina;
  3. Pregnant women, lactating women or women of childbearing age who have birth requirements;
  4. Mental patients, or cognitive dysfunction;
  5. The investigator believes that there are other situations that are not suitable for the trial.
Sex/Gender
Sexes Eligible for Study: All
Ages 35 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04026724
Other Study ID Numbers RCSCD-TCM
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Responsible Party Chunquan Yu, Tianjin University of Traditional Chinese Medicine
Study Sponsor Tianjin University of Traditional Chinese Medicine
Collaborators Not Provided
Investigators Not Provided
PRS Account Tianjin University of Traditional Chinese Medicine
Verification Date July 2019

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