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Recruiting NCT06881173

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

No phase Interventional Myasthenia Gravis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bu Zhong Yi Qi Tang, caramel dyed starch placebo.
Who it may be relevant to
Registry conditions: Myasthenia Gravis. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • meridian energy [Time frame: 12 weeks]
  • autonomic nervous system function [Time frame: 12 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • Shin Kong Wu Ho-Su Memorial Hospital — Taipei

Identifiers

NCT: NCT06881173 · 20220305R

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗