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

NCT ID: NCT06881173

Last Updated: 2025-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-14

Study Completion Date

2025-06-13

Brief Summary

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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

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: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.

Conditions

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Myasthenia Gravis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Experimental group

Have taken Bu Zhong Yi Qi Tang

Group Type EXPERIMENTAL

Bu Zhong Yi Qi Tang

Intervention Type DRUG

The experimental group took 15g of Buzhong Yiqi Decoction concentrated powder, 3 times a day, 1 packet each time.

control group

Have taken caramel dyed starch placebo

Group Type PLACEBO_COMPARATOR

caramel dyed starch placebo

Intervention Type DRUG

The control group took 15 grams of caramel dyed starch placebo, 1 pack at a time, 3 times a day.

Interventions

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Bu Zhong Yi Qi Tang

The experimental group took 15g of Buzhong Yiqi Decoction concentrated powder, 3 times a day, 1 packet each time.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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TE202208013 starch placebo

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cheng, yu-ting

OTHER

Sponsor Role lead

Responsible Party

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Cheng, yu-ting

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ju-Han Liu

Role: STUDY_CHAIR

project leader

Locations

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Shin Kong Wu Ho-Su Memorial Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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yuting Cheng

Role: CONTACT

+8860988773890

Facility Contacts

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yuting Cheng

Role: primary

+886988773890

Other Identifiers

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20220305R

Identifier Type: -

Identifier Source: org_study_id

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