The Personalized Chinese Herb Formulas Over Hypertensive Bradyarrhythmia

NCT04505228 | Completed

• 1 other identifier: qdms17337nsh
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertensive Heart Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Research group

EXPERIMENTAL

The patients receiving Atropine and the extra Chinese herb formulas treatment

Drug: Safflower (Carthamus Tinctorius) IgG4 | Serum | Allergy; Drug: Atropine Sulfate

Control group

ACTIVE COMPARATOR

The patients receiving the basic treatment of atropine

Drug: Atropine Sulfate

Interventions

Safflower (Carthamus Tinctorius) IgG4 | Serum | Allergy DRUG

The designed Chinese herb formulas

Also known as: Xuefuzhuyu

Research group

Atropine Sulfate DRUG

The basic treatment for heart disease

Control group; Research group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \* Clinical diagnosis of hypertensive bradyarhhythmia

You may not qualify if:

• With other elementary diseases
• With pregnant
• With receiving other treatment within past half year from the beginning of trial.

Sponsors & Collaborators

• Jun Xiao: lead
• Qingdao Fifth People's Hospital: collaborator

Study Sites (1)

The fifth Qingdao people's hospital

Qingdao, Shandong, 266000, China

Location

MeSH Terms

Interventions

Honghua extract, Carthamus tinctorius; Immunoglobulin G; Sensitivity and Specificity; Atropine

Intervention Hierarchy (Ancestors)

Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Statistics as Topic; Mathematical Concepts; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 2, 2020
• First Posted: August 10, 2020
• Study Start: January 20, 2020
• Primary Completion: March 20, 2020
• Study Completion: June 20, 2020
• Last Updated: August 10, 2020

Record last verified: 2020-08

Locations

CN (1)