Myasthenia GravisNCT06881173
The Effectiveness of Bu Zhong Yi Qi Tang in Patients with Myasthenia Gravis
A study testing Bu Zhong Yi Qi Tang in people with Myasthenia Gravis, run by Cheng, yu-ting at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Myasthenia Gravis
- What is being tested?
- Bu Zhong Yi Qi Tang
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Jun 2022to 13 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Shin Kong Wu Ho-Su Memorial Hospital
Taipei
yuting Cheng, +886988773890, tyghaw3261635@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Myasthenia Gravis
- Being tested
- Bu Zhong Yi Qi Tang, caramel dyed starch placebo
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bu Zhong Yi Qi TangDrug
Also called TE202208013
The experimental group took 15g of Buzhong Yiqi Decoction concentrated powder, 3 times a day, 1 packet each time.
caramel dyed starch placeboDrug
Also called starch placebo
The control group took 15 grams of caramel dyed starch placebo, 1 pack at a time, 3 times a day.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Have taken Bu Zhong Yi Qi Tang Receives: Drug: Bu Zhong Yi Qi Tang |
| control group | Placebo comparator | Have taken caramel dyed starch placebo Receives: Drug: caramel dyed starch placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start14 Jun 2022
- Primary completion13 Jun 2025 (estimated)
- Study completion13 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myasthenia GravisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cheng, yu-ting
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cheng, yu-ting, National Taipei University of Nursing and Health Sciences
- Investigators
- Ju-Han Liu, Study chair, project leader
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06881173
- Sponsor's protocol ID
- 20220305R
- Status last verified
- Aug 2024
- First submitted
- 6 Aug 2024
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Meridian Energy and Heart Rate Variability in Patients with Ocular Myasthenia Gravis by Using Chinese and Western Medicine Treatment
- ClinicalTrials.gov ID
- NCT06881173
- Acronym / sponsor ID
- 20220305R
- Conditions
- Myasthenia Gravis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Cheng, yu-tingUniversity, hospital or other
- Study start
- 14 Jun 2022 (actual)
- Primary completion
- 13 Jun 2025 (estimated)
- Study completion
- 13 Jun 2025 (estimated)
- First posted
- 18 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Bu Zhong Yi Qi TangHave taken Bu Zhong Yi Qi Tang |
| control group | Placebo comparator | Drug: caramel dyed starch placeboHave taken caramel dyed starch placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bu Zhong Yi Qi TangAlso: TE202208013The experimental group took 15g of Buzhong Yiqi Decoction concentrated powder, 3 times a day, 1 packet each time. | Drug | Experimental group |
| caramel dyed starch placeboAlso: starch placeboThe control group took 15 grams of caramel dyed starch placebo, 1 pack at a time, 3 times a day. | Drug | control group |
Primary outcome
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.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ju-Han Liu study chair
project leader
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bu Zhong Yi Qi Tang in people with Myasthenia Gravis, run by Cheng, yu-ting at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yuting Cheng (+8860988773890, tyghaw3261635@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
meridian energy (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.