The Personalized Chinese Herb Formulas Over Hypertensive Bradyarrhythmia

Hypertensive Heart Disease Clinical Trial

Official title:

The Personalized Chinese Herb Formulas Are Evaluated for Their Effectiveness to Relieve Symptoms in Hypertensive Bradyarrhythmia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04505228
• Other study ID #: qdms17337nsh
• Status: Completed
• Phase: N/A
• Start date: January 20, 2020
• Est. completion date: June 20, 2020

Study information

• Verified date: August 2020
• Source: Macrohard Institute of Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 20, 2020
• Est. primary completion date: March 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bradycardia
• Heart Diseases
• Hypertensive Heart Disease

Intervention

Drug:
• Safflower (Carthamus Tinctorius) IgG4 | Serum | Allergy
The designed Chinese herb formulas
• Atropine Sulfate
The basic treatment for heart disease

Locations

Country	Name	City	State
China	The fifth Qingdao people's hospital	Qingdao	Shandong

Sponsors (2)

Lead Sponsor	Collaborator
Jun Xiao	Qingdao Fifth People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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".	2 weeks