Parkinson's DiseaseNCT06304285
A Study Assessing the Effects of Acupuncture in Parkinson's Disease Patients With Chronic Appendicitis
A study testing Acupuncture treatment in people with Parkinson's Disease and Chronic Appendicitis, run by The First Affiliated Hospital of University of Science and Technology of China at 1 site in China.
Trial summary
The incidence of PD is high, and when the disease is serious to a certain extent, the effect of drugs to control symptoms decreases, resulting in a significant reduction in the quality of life of patients. Recent studies have found that these PD symptoms are closely related to the intestine. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Parkinson's Disease, Chronic Appendicitis, Acupuncture
- What is being tested?
- Acupuncture treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting with bradykinesia, combined with resting tremor and/or myotonia.
- Appendix CT suggested chronic appendicitis evaluated by two experienced experts.
- All subjects and their guardians give informed consent to the content of this study and sign informed consent.
- Normal coagulation function.
- If the patient had taken oral anti-PD drugs, it had been stable for at least 2 weeks at enrollment.
Who cannot join
- Treatment with dopamine blockers or dopamine depleters in doses and time courses consistent with drug-induced parkinsonism.
- Neuroimaging examination of presynaptic dopaminergic system function was normal.
- Patients who had suffered severe brain trauma or underwent complex craniotomy within 5 years prior to enrollment.
- Cognitive disorders that are not on the Parkinson's spectrum, such as Alzheimer's disease, frontotemporal dementia, and Niemann-Pick disease, have been diagnosed.
- People diagnosed with severe neuropsychiatric disorders (epilepsy, bipolar disorder, major depressive episode, etc.) according to DSM-V.
- Complicated with serious systemic diseases, disorders of consciousness, stroke, serious coronary heart disease, diabetes, liver and kidney diseases, and serious visual and hearing disorders.
- Patients with severe organic or functional dysphagia;Those who were deemed by the researcher to be unable to complete the visit and auxiliary examination as required by the study protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, 230001
Yuhua Chen, M.M.S., +8615955236270, yh1215@mail.ustc.edu.cn
Chao Han, M.D., +8615255629713, chaohan@ustc.edu.cn
About this study
Official title: A Study Assessing the Effects of Acupuncture in Parkinson's Disease Patients With Chronic Appendicitis: a Single-center, Randomized, Double-blind Study
The incidence of PD is high, and when the disease is serious to a certain extent, the effect of drugs to control symptoms decreases, resulting in a significant reduction in the quality of life of patients. Recent studies have found that these PD symptoms are closely related to the intestine. For several cases of PD syndrome patients complicated with chronic appendicitis, our research group conducted acupuncture on points related to constipation and chronic appendicitis, and found that constipation and related motor symptoms of patients could be significantly improved. Clinical studies have shown that acupuncture also has a certain therapeutic effect on non-motor symptoms of Parkinson's disease, such as anxiety and depression, decreased olfactory function, sleep disorders, constipation, early skeletal muscle pain, cognitive dysfunction, etc., which can delay the progression of the disease and improve the quality of life of patients. Starting from intestinal acupuncture, this project further clarified the role of acupuncture treatment in the comprehensive treatment of PD
- Conditions
- Parkinson's Disease, Chronic Appendicitis, Acupuncture
- Being tested
- Acupuncture treatment, Sham acupuncture treatment
- Keywords
- Parkinson's disease, acupuncture
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture treatmentOther
Acupuncture was performed according to the corresponding acupoint of the patient
Sham acupuncture treatmentOther
The needle only touches the patient's skin and does not penetrate the skin
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture group | Experimental | The subjects received acupuncture treatment at the following points: Tianshu, Zusanli, Hegu, Taichong, Shangjuxu, Jigou, Zhaohai, Lanwei and shousanli. Receives: Other: Acupuncture treatment |
| control group | Sham comparator | Treatment with comfort needle and comfort embedding needle Receives: Other: Sham acupuncture treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of MDS Unified-Parkinson Disease Rating Scale III
The changes of MDS-UPDRS III scores before and after acupuncture treatment were compared.The lowest score was 0 and the highest was 132, with higher scores indicating more severe symptoms.
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start1 Mar 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies 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, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of University of Science and Technology of China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuhua Chen, M.M.S., Study chair, The First Affiliated Hospital of University of Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06304285
- Sponsor's protocol ID
- 2023-ky421
- Status last verified
- Mar 2024
- First submitted
- 27 Feb 2024
- Last updated
- 12 Mar 2024
- 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 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Assessing the Effects of Acupuncture in Parkinson's Disease Patients With Chronic Appendicitis: a Single-center, Randomized, Double-blind Study
- ClinicalTrials.gov ID
- NCT06304285
- Acronym / sponsor ID
- 2023-ky421
- Conditions
- Parkinson's Disease, Chronic Appendicitis, Acupuncture
- Keywords
- Parkinson's disease, acupuncture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of University of Science and Technology of ChinaUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Mar 2024 (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.
The incidence of PD is high, and when the disease is serious to a certain extent, the effect of drugs to control symptoms decreases, resulting in a significant reduction in the quality of life of patients. Recent studies have found that these PD symptoms are closely related to the intestine. For several cases of PD syndrome patients complicated with chronic appendicitis, our research group conducted acupuncture on points related to constipation and chronic appendicitis, and found that constipation and related motor symptoms of patients could be significantly improved. Clinical studies have shown that acupuncture also has a certain therapeutic effect on non-motor symptoms of Parkinson's disease, such as anxiety and depression, decreased olfactory function, sleep disorders, constipation, early skeletal muscle pain, cognitive dysfunction, etc., which can delay the progression of the disease and improve the quality of life of patients. Starting from intestinal acupuncture, this project further clarified the role of acupuncture treatment in the comprehensive treatment of PD
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture group | Experimental | Other: Acupuncture treatmentThe subjects received acupuncture treatment at the following points: Tianshu, Zusanli, Hegu, Taichong, Shangjuxu, Jigou, Zhaohai, Lanwei and shousanli. |
| control group | Sham comparator | Other: Sham acupuncture treatmentTreatment with comfort needle and comfort embedding needle |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients presenting with bradykinesia, combined with resting tremor and/or myotonia.
- Appendix CT suggested chronic appendicitis evaluated by two experienced experts.
- All subjects and their guardians give informed consent to the content of this study and sign informed consent.
- Normal coagulation function.
- If the patient had taken oral anti-PD drugs, it had been stable for at least 2 weeks at enrollment.
Key exclusion criteria (7 listed)
- Treatment with dopamine blockers or dopamine depleters in doses and time courses consistent with drug-induced parkinsonism.
- Neuroimaging examination of presynaptic dopaminergic system function was normal.
- Patients who had suffered severe brain trauma or underwent complex craniotomy within 5 years prior to enrollment.
- Cognitive disorders that are not on the Parkinson's spectrum, such as Alzheimer's disease, frontotemporal dementia, and Niemann-Pick disease, have been diagnosed.
- People diagnosed with severe neuropsychiatric disorders (epilepsy, bipolar disorder, major depressive episode, etc.) according to DSM-V.
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 |
|---|---|---|
| Acupuncture treatmentAcupuncture was performed according to the corresponding acupoint of the patient | Other | Acupuncture group |
| Sham acupuncture treatmentThe needle only touches the patient's skin and does not penetrate the skin | Other | control group |
Primary outcome
Score of MDS Unified-Parkinson Disease Rating Scale III
Time frame: 3 month
The changes of MDS-UPDRS III scores before and after acupuncture treatment were compared.The lowest score was 0 and the highest was 132, with higher scores indicating more severe symptoms.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- 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.
Yuhua Chen, M.M.S. study chair
The First Affiliated Hospital of University of Science and Technology of China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture treatment in people with Parkinson's Disease and Chronic Appendicitis, run by The First Affiliated Hospital of University of Science and Technology of China at 1 site in China.
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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 12 Mar 2024. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuhua Chen, M.M.S. (+8615955236270, yh1215@mail.ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of MDS Unified-Parkinson Disease Rating Scale III (time frame: 3 month). 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 12 Mar 2024.