Buyang Huanwu Decoction and Normal Tension Glaucoma

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06054763
• Other study ID #: CMUH112-REC3-126
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chinese Medicine
• Glaucoma
• Low Tension Glaucoma
• Visual Acuity
• Visual Field

Intervention

Combination Product:
• 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.

Other:
• Placebo
90% starch and 10% Buyang Huanwu Decoction

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in visual acuity	The difference of visual acuity between study baseline and the 12 weeks of intervention.	12 weeks