GlaucomaNCT06054763
Buyang Huanwu Decoction and Normal Tension Glaucoma
A study testing Buyang Huanwu Decoction in people with Glaucoma and Visual Acuity, run by China Medical University Hospital.
Trial summary
The goal of this clinical trial is to test Buyang Huanwu Decoction in normal intra-ocular pressure glaucoma. The main question to answer is: the effect of Buyang Huanwu Decoction and its safety in patients with normal intra-ocular pressure glaucoma. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Glaucoma, Visual Acuity, Visual Field
- What is being tested?
- Buyang Huanwu Decoction
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 31 Dec 2024
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of normal tension glaucoma for at least 3 months.
- Using less than 1 medicine for glaucoma.
- Without any eye disease other than normal tension glaucoma.
- Writing the Informed Consent Form by themselves.
Who cannot join
- With other chronic diseases, such as diabetes, hypertension, cancer.
- With polypharmacy.
- Had glaucoma surgery or myopia laser surgery before the study.
- With mental disease and could not finish the study.
- Allergic to Buyang Huanwu Decoction.
- Pregnancy or lactation.
About this study
Official title: Traditional Chinese Herbal Medicine Buyang Huanwu Decoction on Visual Acuity and Visual Field in Patients With Normal Tension Glaucoma：a Double-blind, Randomized Controlled Trial
The goal of this clinical trial is to test Buyang Huanwu Decoction in normal intra-ocular pressure glaucoma. The main question to answer is: the effect of Buyang Huanwu Decoction and its safety in patients with normal intra-ocular pressure glaucoma.
Participants will take 3 grams of Buyang Huanwu Decoction or placebo for 12 weeks.
Researchers will compare treatment group and placebo group to see if the visual acuity, visual field would be improved.
Read the detailed description
There is currently no active and effective treatment for normal intra-ocular pressure glaucoma, and glaucoma patients often affect the optic nerve and cause visual acuity and visual field damage. Studies have found that glaucoma patients have less blood flow to the optic nerve, retina and choroid than normal people. Buyang Huanwu Decoction has the functions of invigorating qi, promoting blood circulation and dredging collaterals, and is often used in the treatment of stroke. Therefore, the purpose of this study is to investigate the effect of Buyang Huanwu Decoction on visual acuity, visual field and its safety in patients with normal intra-ocular pressure glaucoma. This study is designed as a randomized, double-blind, controlled clinical trial. A total of 60 subjects with normal intra-ocular pressure glaucoma were randomly divided into: 1) treatment group (30 subjects), oral administration of Buyang Huanwu Decoction (3 grams), two times in a day after breakfast and dinner, for 12 consecutive weeks; 2) control group (30 subjects), the same method as the treatment group, but taking Buyang Huanwu Decoction placebo (90% starch and 10% Buyang Huanwu Decoction). Primary outcome was changes in visual acuity, visual field, and optic nerve fiber layer, and secondary outcome was changes in quality of life scale scores.
- Conditions
- Glaucoma, Visual Acuity, Visual Field, Chinese Medicine
- Being tested
- Buyang Huanwu Decoction, Placebo
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buyang Huanwu DecoctionCombination product
Buyang Huanwu Decoction is a common prescription for treating stroke. The possible mechanism is to replenish qi, activate blood circulation, and remove blood stasis.
PlaceboOther
90% starch and 10% Buyang Huanwu Decoction
| Study group | Role | What they receive |
|---|---|---|
| Buyang Huanwu Decoction group | Experimental | Oral administration of Buyang Huanwu Decoction (3 grams), two times in a day after breakfast and dinner, for 12 consecutive weeks Receives: Combination Product: Buyang Huanwu Decoction |
| Placebo group | Placebo comparator | the same method as the treatment group, but taking Buyang Huanwu Decoction placebo (90% starch and 10% Buyang Huanwu Decoction) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in visual acuity
The difference of visual acuity between study baseline and the 12 weeks of intervention.
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 posted26 Sep 2023
- Study start1 Oct 2023 (estimated)
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ching-Liang Hsieh, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06054763
- Sponsor's protocol ID
- CMUH112-REC3-126
- Status last verified
- Sep 2023
- First submitted
- 20 Sep 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traditional Chinese Herbal Medicine Buyang Huanwu Decoction on Visual Acuity and Visual Field in Patients With Normal Tension Glaucoma：a Double-blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06054763
- Acronym / sponsor ID
- CMUH112-REC3-126
- Conditions
- Glaucoma, Visual Acuity, Visual Field, Chinese Medicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Sep 2023 (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 goal of this clinical trial is to test Buyang Huanwu Decoction in normal intra-ocular pressure glaucoma. The main question to answer is: the effect of Buyang Huanwu Decoction and its safety in patients with normal intra-ocular pressure glaucoma.
Participants will take 3 grams of Buyang Huanwu Decoction or placebo for 12 weeks.
Researchers will compare treatment group and placebo group to see if the visual acuity, visual field would be improved.
Detailed description
There is currently no active and effective treatment for normal intra-ocular pressure glaucoma, and glaucoma patients often affect the optic nerve and cause visual acuity and visual field damage. Studies have found that glaucoma patients have less blood flow to the optic nerve, retina and choroid than normal people. Buyang Huanwu Decoction has the functions of invigorating qi, promoting blood circulation and dredging collaterals, and is often used in the treatment of stroke. Therefore, the purpose of this study is to investigate the effect of Buyang Huanwu Decoction on visual acuity, visual field and its safety in patients with normal intra-ocular pressure glaucoma. This study is designed as a randomized, double-blind, controlled clinical trial. A total of 60 subjects with normal intra-ocular pressure glaucoma were randomly divided into: 1) treatment group (30 subjects), oral administration of Buyang Huanwu Decoction (3 grams), two times in a day after breakfast and dinner, for 12 consecutive weeks; 2) control group (30 subjects), the same method as the treatment group, but taking Buyang Huanwu Decoction placebo (90% starch and 10% Buyang Huanwu Decoction). Primary outcome was changes in visual acuity, visual field, and optic nerve fiber layer, and secondary outcome was changes in quality of life scale scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buyang Huanwu Decoction group | Experimental | Combination Product: Buyang Huanwu DecoctionOral administration of Buyang Huanwu Decoction (3 grams), two times in a day after breakfast and dinner, for 12 consecutive weeks |
| Placebo group | Placebo comparator | Other: Placebothe same method as the treatment group, but taking Buyang Huanwu Decoction placebo (90% starch and 10% Buyang Huanwu Decoction) |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of normal tension glaucoma for at least 3 months.
- Using less than 1 medicine for glaucoma.
- Without any eye disease other than normal tension glaucoma.
- Writing the Informed Consent Form by themselves.
Key exclusion criteria (6 listed)
- With other chronic diseases, such as diabetes, hypertension, cancer.
- With polypharmacy.
- Had glaucoma surgery or myopia laser surgery before the study.
- With mental disease and could not finish the study.
- Allergic to Buyang Huanwu Decoction.
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 |
|---|---|---|
| Buyang Huanwu DecoctionBuyang Huanwu Decoction is a common prescription for treating stroke. The possible mechanism is to replenish qi, activate blood circulation, and remove blood stasis. | Combination product | Buyang Huanwu Decoction group |
| Placebo90% starch and 10% Buyang Huanwu Decoction | Other | Placebo group |
Primary outcome
Changes in visual acuity
Time frame: 12 weeks
The difference of visual acuity between study baseline and the 12 weeks of intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Buyang Huanwu Decoction in people with Glaucoma and Visual Acuity, run by China Medical University Hospital.
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 4 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 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Changes in visual acuity (time frame: 12 weeks). 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 28 Sep 2023.