Buyang Huanwu Decoction and Normal Tension Glaucoma

China Medical University

Status: Not yet enrolling

Conditions: Visual Field; Glaucoma; Chinese Medicine; Visual Acuity

Treatments: Combination Product: Buyang Huanwu Decoction; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06054763

CMUH112-REC3-126

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Buyang Huanwu Decoction group

Experimental group

Description:

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

Treatment:

Combination Product: Buyang Huanwu Decoction

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo