The Effectiveness of Bu Zhong Yi Qi Tang in Patients with Myasthenia Gravis

March 17, 2025 updated by: Cheng, yu-ting

Efficacy of Meridian Energy and Heart Rate Variability in Patients with Ocular Myasthenia Gravis by Using Chinese and Western Medicine Treatment

Research Background: According to the Myasthenia Gravis Foundation of America (MGFA, 2015), the estimated prevalence of myasthenia gravis is 14-20 per 100,000 people, with a higher prevalence in young female individuals compared to males. However, as individuals age, especially after the age of 50, the prevalence in males becomes higher than in females. myasthenia gravis patients often experience varying degrees of disability, leading to the need for long-term medical care, medication, and lifestyle adjustments. This also gives rise to subsequent challenges in caregiving, affecting both the patients' families and society.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

:This study aims to assess the effectiveness of using a combination of traditional Chinese and Western medicine,to improve the meridian energy and autonomic nervous system function of myasthenia gravis patients.

Study Type

Interventional

Enrollment (Estimated)

112

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 Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • Shin Kong Wu Ho-Su Memorial Hospital
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients diagnosed with ocular myasthenia by a doctor
  • Western medicine prescriptions only take oral Mestinon (Pyrido stigmine Bromide)
  • Patients over 20 years old
  • Can understand and understand Those who can speak Mandarin or Taiwanese
  • those with a clear state of consciousness and no diagnosis of mental illness
  • patients and their families who are willing to receive precise integrated treatment of traditional Chinese and Western medicine.

Exclusion Criteria:

  • Patients with liver failure or kidney failure
  • Allergy symptoms to traditional Chinese medicine, such as skin itching and redness
  • Patients with malignant tumors
  • Patients currently undergoing radiotherapy and chemotherapy
  • Pregnant
  • Cardiac rhythm device implementer

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Have taken Bu Zhong Yi Qi Tang
Drug: Bu Zhong Yi Qi Tang
The experimental group took 15g of Buzhong Yiqi Decoction concentrated powder, 3 times a day, 1 packet each time.
Other Names:
  • TE202208013
Placebo Comparator: control group
Have taken caramel dyed starch placebo
Drug: caramel dyed starch placebo
The control group took 15 grams of caramel dyed starch placebo, 1 pack at a time, 3 times a day.
Other Names:
  • starch placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
meridian energy
Time Frame: 12 weeks
After taking Buzhong Yiqi Decoction, the energy of the meridians can be balanced. Use a meridian measuring instrument to measure the meridians of the whole body and improve the energy of the meridians to the range of 40-60.
12 weeks
autonomic nervous system function
Time Frame: 12 weeks
After taking Buzhong Yiqi Decoction, it can change the autonomic nervous system (ANS), reduce the sympathetic nerve energy, increase the parasympathetic nerve energy, and set the standard value of the autonomic nervous system activity between 40-60
12 weeks

Collaborators and Investigators

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

Sponsor

Cheng, yu-ting

Investigators

  • Study Chair: Ju-Han Liu, project leader

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)

June 14, 2022

Primary Completion (Estimated)

June 13, 2025

Study Completion (Estimated)

June 13, 2025

Study Registration Dates

First Submitted

August 6, 2024

First Submitted That Met QC Criteria

March 11, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 17, 2025

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20220305R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Clinical Trials on Myasthenia Gravis

Clinical Trials on Bu Zhong Yi Qi Tang

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Benin

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe