GlaucomaNCT04157530
Clinical Evaluation of Acupuncture in Treating Glaucoma
A study testing wang-bu-liu-xing, acupuncture and Electroacupuncture in people with Glaucoma and Acupuncture, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
The present study predicts that acupuncture or electroacupuncture can reduce intraocular pressure and also can improve quality of life in patients with glaucoma. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Glaucoma, Acupuncture
- What is being tested?
- wang-bu-liu-xing, acupuncture and Electroacupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2018to 1 Nov 2019
- 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
- Glaucoma for at least three months
- Do not use ocular hypotensive drugs or use only one ocular hypotensive drug.
- It is over 20 years old.
- Men and women are informal.
- There is no evidence other than glaucoma that shows other eye diseases.
- Be aware and fill out the consent form yourself.
Who cannot join
- Combines other chronic diseases, taking multiple medications such as high blood pressure, diabetes, etc.
- Those who have had glaucoma surgery.
- Those who had undergone myopia laser surgery.
- Can not accept acupuncture points stimulators.
- Allergic to acupuncture needles.
- Has a mental illness or is unable to cooperate with the researcher.
- Do not sign consent
Trial locations and contacts
1 site in 1 country.
About this study
The present study predicts that acupuncture or electroacupuncture can reduce intraocular pressure and also can improve quality of life in patients with glaucoma.
Read the detailed description
Glaucoma is a syndrome, and that is results from intraocular pressure increases cause visual field narrow and blindness. The incidence of adult blindness induced by glaucoma is second in the ophthalmologic disease in the world. Many studies report that both blood circulation in the eye surroundings and intraocular pressure increase play an important role in glaucoma. Several studies show that acupuncture can modulate intraocular pressure and improve activity of central visual acuity and also increase blood flow of eye fundus. Jingming (BL1) can communicate yi and yang, and nourish and clear eyes, Qiuhou (EX-HN7) can transport qi and activate blood, and freely flowing meridian and clear eyes. Therefore, the purpose of the present study was to investigate the therapeutic effect of acupuncture at Jinming and Qiuhou on intraocular pressure in patients with glaucoma. The study designed as a single-blinded, randomized, controlled clinical trial, a total of45 patients with glaucoma divided into three groups, each group was15 subjects as follows: 1) sham group, using the seeds of wang-bu-liu-xing applied on the surface of Jinming and Qiuhou acupoints, one times/day, and each time was 20 min, twice/week for 2 weeks; 2) acupuncture group, the methods were identical to the sham group, but used acupuncture applied to Qingming and Qiuhou with Der-qi; 3) Electroacupuncture group, the methods were identical to acupuncture, but the needles of Qinming and Qiuhou connected to the electroacupuncture machine after Der-qi, the frequencies of stimulus were 6 Hz, the intensity of stimulus was minimal visible muscle twitch. Primary outcome measure was the changes of intraocular pressure, and the second outcome measure was the score changes of WHOQOL-REF (Taiwan version).
The present study predicts that acupuncture or electroacupuncture can reduce intraocular pressure and also can improve quality of life in patients with glaucoma.
- Conditions
- Glaucoma, Acupuncture
- Being tested
- wang-bu-liu-xing, acupuncture, Electroacupuncture
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wang-bu-liu-xingDevice
Also called Canon Pneumotonometer
wang-bu-liu-xing applied on the surface of Jinming and Qiuhou acupoints
acupunctureDevice
acupuncture applied to Qingming and Qiuhou with Der-qi
ElectroacupunctureDevice
acupuncture, but the needles of Qinming and Qiuhou connected to the electroacupuncture machine after Der-qi, the frequencies of stimulus were 6 Hz, the intensity of stimulus was minimal visible muscle twitch
| Study group | Role | What they receive |
|---|---|---|
| sham group | Sham comparator | 15 subjects with seeds of wang-bu-liu-xing applied on the surface of Jinming and Qiuhou acupoints Receives: Device: wang-bu-liu-xing |
| acupuncture group | Experimental | 15 subjects with acupuncture applied to Qingming and Qiuhou with Der-qi Receives: Device: acupuncture |
| Electroacupuncture group | Experimental | 15 subjects wth acupuncture, but the needles of Qinming and Qiuhou connected to the electroacupuncture machine after Der-qi Receives: Device: Electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraocular pressure
Primary outcome measure was the changes of intraocular pressure,
Measured: 20 min, twice/week for 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start1 Mar 2018
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ching-Liang Hsieh, PhD, Principal investigator, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04157530
- Sponsor's protocol ID
- CMUH106-REC2-161
- Status last verified
- Nov 2019
- First submitted
- 12 Mar 2018
- Last updated
- 8 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mac Nair CE, Nickells RW. Neuroinflammation in Glaucoma and Optic Nerve Damage. Prog Mol Biol Transl Sci. 2015;134:343-63. doi: 10.1016/bs.pmbts.2015.06.010. Epub 2015 Jul 10.
PubMed 26310164Chen SY, Yieh FS, Liao WL, Li TC, Hsieh CL. Effect of Acupuncture on Intraocular Pressure in Glaucoma Patients: A Single-Blinded, Randomized, Controlled Trial. Evid Based Complement Alternat Med. 2020 Apr 28;2020:7208081. doi: 10.1155/2020/7208081. eCollection 2020.
PubMed 32419820
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Acupuncture in Treating Glaucoma
- ClinicalTrials.gov ID
- NCT04157530
- Acronym / sponsor ID
- CMUH106-REC2-161
- Conditions
- Glaucoma, Acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 8 Nov 2019 (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 present study predicts that acupuncture or electroacupuncture can reduce intraocular pressure and also can improve quality of life in patients with glaucoma.
Detailed description
Glaucoma is a syndrome, and that is results from intraocular pressure increases cause visual field narrow and blindness. The incidence of adult blindness induced by glaucoma is second in the ophthalmologic disease in the world. Many studies report that both blood circulation in the eye surroundings and intraocular pressure increase play an important role in glaucoma. Several studies show that acupuncture can modulate intraocular pressure and improve activity of central visual acuity and also increase blood flow of eye fundus. Jingming (BL1) can communicate yi and yang, and nourish and clear eyes, Qiuhou (EX-HN7) can transport qi and activate blood, and freely flowing meridian and clear eyes. Therefore, the purpose of the present study was to investigate the therapeutic effect of acupuncture at Jinming and Qiuhou on intraocular pressure in patients with glaucoma. The study designed as a single-blinded, randomized, controlled clinical trial, a total of45 patients with glaucoma divided into three groups, each group was15 subjects as follows: 1) sham group, using the seeds of wang-bu-liu-xing applied on the surface of Jinming and Qiuhou acupoints, one times/day, and each time was 20 min, twice/week for 2 weeks; 2) acupuncture group, the methods were identical to the sham group, but used acupuncture applied to Qingming and Qiuhou with Der-qi; 3) Electroacupuncture group, the methods were identical to acupuncture, but the needles of Qinming and Qiuhou connected to the electroacupuncture machine after Der-qi, the frequencies of stimulus were 6 Hz, the intensity of stimulus was minimal visible muscle twitch. Primary outcome measure was the changes of intraocular pressure, and the second outcome measure was the score changes of WHOQOL-REF (Taiwan version).
The present study predicts that acupuncture or electroacupuncture can reduce intraocular pressure and also can improve quality of life in patients with glaucoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| sham group | Sham comparator | Device: wang-bu-liu-xing15 subjects with seeds of wang-bu-liu-xing applied on the surface of Jinming and Qiuhou acupoints |
| acupuncture group | Experimental | Device: acupuncture15 subjects with acupuncture applied to Qingming and Qiuhou with Der-qi |
| Electroacupuncture group | Experimental | Device: Electroacupuncture15 subjects wth acupuncture, but the needles of Qinming and Qiuhou connected to the electroacupuncture machine after Der-qi |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Glaucoma for at least three months
- Do not use ocular hypotensive drugs or use only one ocular hypotensive drug.
- It is over 20 years old.
- Men and women are informal.
- There is no evidence other than glaucoma that shows other eye diseases.
Key exclusion criteria (7 listed)
- Combines other chronic diseases, taking multiple medications such as high blood pressure, diabetes, etc.
- Those who have had glaucoma surgery.
- Those who had undergone myopia laser surgery.
- Can not accept acupuncture points stimulators.
- Allergic to acupuncture needles.
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 |
|---|---|---|
| wang-bu-liu-xingAlso: Canon Pneumotonometerwang-bu-liu-xing applied on the surface of Jinming and Qiuhou acupoints | Device | sham group |
| acupunctureacupuncture applied to Qingming and Qiuhou with Der-qi | Device | acupuncture group |
| Electroacupunctureacupuncture, but the needles of Qinming and Qiuhou connected to the electroacupuncture machine after Der-qi, the frequencies of stimulus were 6 Hz, the intensity of stimulus was minimal visible muscle twitch | Device | Electroacupuncture group |
Primary outcome
intraocular pressure
Time frame: 20 min, twice/week for 2 weeks
Primary outcome measure was the changes of intraocular pressure,
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
- Results publication: PubMed 26310164Mac Nair CE, Nickells RW. Neuroinflammation in Glaucoma and Optic Nerve Damage. Prog Mol Biol Transl Sci. 2015;134:343-63. doi: 10.1016/bs.pmbts.2015.06.010. Epub 2015 Jul 10.
- Derived from this study: PubMed 32419820Chen SY, Yieh FS, Liao WL, Li TC, Hsieh CL. Effect of Acupuncture on Intraocular Pressure in Glaucoma Patients: A Single-Blinded, Randomized, Controlled Trial. Evid Based Complement Alternat Med. 2020 Apr 28;2020:7208081. doi: 10.1155/2020/7208081. eCollection 2020.
- 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.
Ching-Liang Hsieh, PhD principal investigator
China Medical University, 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 wang-bu-liu-xing, acupuncture and Electroacupuncture in people with Glaucoma and Acupuncture, run by China Medical University Hospital 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 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: finished, as of the sponsor's last update on 8 Nov 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraocular pressure (time frame: 20 min, twice/week for 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04157530, which also lists 2 linked publications.
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 8 Nov 2019.