The Personalized Chinese Herb Formulas Over Hypertensive Bradyarrhythmia

August 5, 2020 updated by: Jun Xiao

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Qingdao, Shandong, China, 266000
        • The fifth Qingdao people's hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Research group
The patients receiving Atropine and the extra Chinese herb formulas treatment
Drug: Safflower (Carthamus Tinctorius) IgG4 | Serum | Allergy
The designed Chinese herb formulas
Other Names:
  • Xuefuzhuyu
Drug: Atropine Sulfate
The basic treatment for heart disease
ACTIVE_COMPARATOR: Control group
The patients receiving the basic treatment of atropine
Drug: Atropine Sulfate
The basic treatment for heart disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
typical symptoms in patients with hypertensive bradyarrhythmia
Time Frame: 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".
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jun Xiao

Collaborators

Qingdao Fifth People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 20, 2020

Primary Completion (ACTUAL)

March 20, 2020

Study Completion (ACTUAL)

June 20, 2020

Study Registration Dates

First Submitted

August 2, 2020

First Submitted That Met QC Criteria

August 5, 2020

First Posted (ACTUAL)

August 10, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 10, 2020

Last Update Submitted That Met QC Criteria

August 5, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • qdms17337nsh

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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