The Personalized Chinese Herb Formulas Over Hypertensive Bradyarrhythmia

Not Applicable

Completed

• Conditions: Hypertensive Heart Disease
• Interventions: Drug: Safflower (Carthamus Tinctorius) IgG4 | Serum | Allergy; Drug: Atropine Sulfate

• Registration Number: NCT04505228
• Lead Sponsor: Jun Xiao

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.

Study Timeline

• Study Start: 2020-01-20
• Primary Completion: 2020-03-20
• Study Completion: 2020-06-20
• Status Verified: 2020-08
• Study First Submitted: 2020-08-02
• Study First Submitted QC: 2020-08-05
• Last Update Submitted: 2020-08-05
• Study First Posted: 2020-08-10
• Last Update Posted: 2020-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Research group	Atropine Sulfate	The patients receiving Atropine and the extra Chinese herb formulas treatment
Research group	Safflower (Carthamus Tinctorius) IgG4 | Serum | Allergy	The patients receiving Atropine and the extra Chinese herb formulas treatment
Control group	Atropine Sulfate	The patients receiving the basic treatment of atropine

Primary Outcome Measures

Name	Time	Method
typical symptoms in patients with hypertensive bradyarrhythmia	2 weeks	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".

Trial Locations

Locations (1)

The fifth Qingdao people's hospital; 🇨🇳 Qingdao, Shandong, China