search
Back to results

Buyang Huanwu Decoction and Normal Tension Glaucoma

Primary Purpose

Glaucoma, Visual Acuity, Visual Field

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Buyang Huanwu Decoction
Placebo
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Buyang Huanwu Decoction group

    Placebo group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Changes in visual acuity
    The difference of visual acuity between study baseline and the 12 weeks of intervention.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 20, 2023
    Last Updated
    September 26, 2023
    Sponsor
    China Medical University Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT06054763
    Brief Title
    Buyang Huanwu Decoction and Normal Tension Glaucoma
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    October 31, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    China Medical University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glaucoma, Visual Acuity, Visual Field, Chinese Medicine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Buyang Huanwu Decoction group
    Arm Type
    Experimental
    Arm Description
    Oral administration of Buyang Huanwu Decoction (3 grams), two times in a day after breakfast and dinner, for 12 consecutive weeks
    Arm Title
    Placebo group
    Arm Type
    Placebo Comparator
    Arm Description
    the same method as the treatment group, but taking Buyang Huanwu Decoction placebo (90% starch and 10% Buyang Huanwu Decoction)
    Intervention Type
    Combination Product
    Intervention Name(s)
    Buyang Huanwu Decoction
    Intervention Description
    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
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    90% starch and 10% Buyang Huanwu Decoction
    Primary Outcome Measure Information:
    Title
    Changes in visual acuity
    Description
    The difference of visual acuity between study baseline and the 12 weeks of intervention.
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Learn more about this trial

    Buyang Huanwu Decoction and Normal Tension Glaucoma

    We'll reach out to this number within 24 hrs