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The Personalized Chinese Herb Formulas Over Hypertensive Bradyarrhythmia

Sponsor
Jun Xiao (Other)
Overall Status
Completed
CT.gov ID
NCT04505228
Collaborator
Qingdao Fifth People's Hospital (Other)
72
Enrollment
1
Location
2
Arms
5
Actual Duration (Months)
14.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Safflower (Carthamus Tinctorius) IgG4 | Serum | Allergy
  • Drug: Atropine Sulfate
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
72 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Personalized Chinese Herb Formulas Are Evaluated for Their Effectiveness to Relieve Symptoms in Hypertensive Bradyarrhythmia
Actual Study Start Date :
Jan 20, 2020
Actual Primary Completion Date :
Mar 20, 2020
Actual Study Completion Date :
Jun 20, 2020

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. 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".

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The fifth Qingdao people's hospital Qingdao Shandong China 266000

    Sponsors and Collaborators

    • Jun Xiao
    • Qingdao Fifth People's Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jun Xiao, Principal Investigator, Macrohard Institute of Health
    ClinicalTrials.gov Identifier:
    NCT04505228
    Other Study ID Numbers:
    • qdms17337nsh
    First Posted:
    Aug 10, 2020
    Last Update Posted:
    Aug 10, 2020
    Last Verified:
    Aug 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Heart Diseases
    Bradycardia
    Atropine

    Study Results

    No Results Posted as of Aug 10, 2020