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

NCT06881173 | Recruiting

• 1 other identifier: 20220305R
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Myasthenia Gravis

Outcome Measures

Primary Outcomes (2)

• meridian energy

  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

  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

Study Arms (2)

Experimental group

EXPERIMENTAL

Have taken Bu Zhong Yi Qi Tang

Drug: Bu Zhong Yi Qi Tang

control group

PLACEBO COMPARATOR

Have taken caramel dyed starch placebo

Drug: caramel dyed starch placebo

Interventions

Bu Zhong Yi Qi Tang DRUG

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

Also known as: TE202208013

Experimental group

caramel dyed starch placebo DRUG

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

Also known as: starch placebo

control group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cheng, yu-ting: lead

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Myasthenia Gravis

Interventions

bu-zhong-yi-qi-tang

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Ju-Han Liu

  project leader

  STUDY CHAIR

Central Study Contacts

yuting Cheng

CONTACT

+8860988773890; tyghaw3261635@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: March 18, 2025
• Study Start: June 14, 2022
• Primary Completion: June 13, 2025
• Study Completion: June 13, 2025
• Last Updated: March 20, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)