Buyang Huanwu Decoction and Normal Tension Glaucoma

NCT06054763 | Unknown

• 1 other identifier: CMUH112-REC3-126
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Glaucoma; Visual Acuity; Visual Field; Chinese Medicine

Outcome Measures

Primary Outcomes (1)

• Changes in visual acuity

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

  12 weeks

Study Arms (2)

Buyang Huanwu Decoction group

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Buyang Huanwu Decoction 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.

Buyang Huanwu Decoction group

Placebo OTHER

90% starch and 10% Buyang Huanwu Decoction

Placebo group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Medical University Hospital: lead

MeSH Terms

Conditions

Glaucoma

Interventions

buyang huanwu

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: September 26, 2023
• Study Start: October 1, 2023
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 28, 2023

Record last verified: 2023-09