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

Not Applicable

Recruiting

• Conditions: Myasthenia Gravis
• Interventions: Drug: Bu Zhong Yi Qi Tang; Drug: caramel dyed starch placebo

• Registration Number: NCT06881173
• Lead Sponsor: Cheng, yu-ting

Brief Summary

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.

Study Timeline

• Study Start: 2022-06-14
• Status Verified: 2024-08
• Study First Submitted: 2024-08-06
• Study First Submitted QC: 2025-03-11
• Last Update Submitted: 2025-03-17
• Study First Posted: 2025-03-18
• Last Update Posted: 2025-03-20
• Primary Completion: 2025-06-13
• Study Completion: 2025-06-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 112

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Bu Zhong Yi Qi Tang	Have taken Bu Zhong Yi Qi Tang
control group	caramel dyed starch placebo	Have taken caramel dyed starch placebo

Primary Outcome Measures

Name	Time	Method
meridian energy	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.
autonomic nervous system function	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

Trial Locations

Locations (1)

Shin Kong Wu Ho-Su Memorial Hospital; 🇨🇳 Taipei, Taiwan