Buyang Huanwu Decoction and Normal Tension Glaucoma

September 26, 2023 updated by: Ching-Liang Hsieh, China Medical University Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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.
Placebo Comparator: Placebo group
the same method as the treatment group, but taking Buyang Huanwu Decoction placebo (90% starch and 10% Buyang Huanwu Decoction)
Other: Placebo
90% starch and 10% Buyang Huanwu Decoction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in visual acuity
Time Frame: 12 weeks
The difference of visual acuity between study baseline and the 12 weeks of intervention.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2023

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

September 20, 2023

First Submitted That Met QC Criteria

September 25, 2023

First Posted (Actual)

September 26, 2023

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMUH112-REC3-126

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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