Buyang Huanwu Decoction and Normal Tension Glaucoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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

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Glaucoma Visual Acuity Visual Field Chinese Medicine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Buyang Huanwu Decoction group

Oral administration of Buyang Huanwu Decoction (3 grams), two times in a day after breakfast and dinner, for 12 consecutive weeks

Group Type EXPERIMENTAL

Buyang Huanwu Decoction

Intervention Type COMBINATION_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.

Placebo group

the same method as the treatment group, but taking Buyang Huanwu Decoction placebo (90% starch and 10% Buyang Huanwu Decoction)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

90% starch and 10% Buyang Huanwu Decoction

Interventions

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Buyang Huanwu Decoction

Buyang Huanwu Decoction is a common prescription for treating stroke. The possible mechanism is to replenish qi, activate blood circulation, and remove blood stasis.

Intervention Type COMBINATION_PRODUCT

Placebo

90% starch and 10% Buyang Huanwu Decoction

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No