Back to resultsThe Personalized Chinese Herb Formulas Over Hypertensive Bradyarrhythmia
Primary Purpose
Hypertensive Heart Disease
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Safflower (Carthamus Tinctorius) IgG4 | Serum | Allergy
Atropine Sulfate
Sponsored by
About this trial
This is an interventional treatment trial for Hypertensive Heart Disease
Eligibility Criteria
Inclusion Criteria:
* Clinical diagnosis of hypertensive bradyarhhythmia
Exclusion Criteria:
- With other elementary diseases
- With pregnant
- With receiving other treatment within past half year from the beginning of trial.
Sites / Locations
- The fifth Qingdao people's hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Research group
Control group
Arm Description
The patients receiving Atropine and the extra Chinese herb formulas treatment
The patients receiving the basic treatment of atropine
Outcomes
Primary Outcome Measures
typical symptoms in patients with hypertensive bradyarrhythmia
The five indexes of typical symptoms in patients with hypertensive bradyarrhythmia (palpitation, angina, shortness of breath, dizzy, lumbar debility) were evaluated and scored both before treatment and after treatment according to "Guiding principles for clinical research of new Chinese Medicine".
Secondary Outcome Measures
Full Information
NCT ID
NCT04505228
First Posted
August 2, 2020
Last Updated
August 5, 2020
Sponsor
Jun Xiao
Collaborators
Qingdao Fifth People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04505228
Brief Title
The Personalized Chinese Herb Formulas Over Hypertensive Bradyarrhythmia
Official Title
The Personalized Chinese Herb Formulas Are Evaluated for Their Effectiveness to Relieve Symptoms in Hypertensive Bradyarrhythmia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 20, 2020 (Actual)
Primary Completion Date
March 20, 2020 (Actual)
Study Completion Date
June 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jun Xiao
Collaborators
Qingdao Fifth People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
72 patients who have been diagnosed with hypertensive bradyarrhythmia were selected and randomly divided into research group and control group. The research group received regular medication against hypertension and the personalized formulas based on syndrome differentiation, meanwhile the control group only received the regular medication. The five symptoms (palpitation, short of breath, angina, dizzy and lumbar debility) were graded and used for evaluation of treatment.
Detailed Description
To test the effect of Chinese herb against the hypertensive heart disease, we designed this randomized controlled clinical trial. 72 patients who have been diagnosed with hypertensive bradyarrhythmia were selected and randomly divided into research group and control group. The five symptoms (palpitation, short of breath, angina, dizzy and lumbar debility) were graded. The research group received regular medication against hypertension and the personalized formulas based on syndrome differentiation, meanwhile the control group only received the regular medication. 2 weeks after treatment, all the symptoms were graded again.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertensive Heart Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Research group
Arm Type
Experimental
Arm Description
The patients receiving Atropine and the extra Chinese herb formulas treatment
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
The patients receiving the basic treatment of atropine
Intervention Type
Drug
Intervention Name(s)
Safflower (Carthamus Tinctorius) IgG4 | Serum | Allergy
Other Intervention Name(s)
Xuefuzhuyu
Intervention Description
The designed Chinese herb formulas
Intervention Type
Drug
Intervention Name(s)
Atropine Sulfate
Intervention Description
The basic treatment for heart disease
Primary Outcome Measure Information:
Title
typical symptoms in patients with hypertensive bradyarrhythmia
Description
The five indexes of typical symptoms in patients with hypertensive bradyarrhythmia (palpitation, angina, shortness of breath, dizzy, lumbar debility) were evaluated and scored both before treatment and after treatment according to "Guiding principles for clinical research of new Chinese Medicine".
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
* Clinical diagnosis of hypertensive bradyarhhythmia
Exclusion Criteria:
With other elementary diseases
With pregnant
With receiving other treatment within past half year from the beginning of trial.
Facility Information:
Facility Name
The fifth Qingdao people's hospital
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Personalized Chinese Herb Formulas Over Hypertensive Bradyarrhythmia
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