Clinical trial

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

Name
CMUH112-REC3-126
Description
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.
Trial arms
Trial start
2023-10-01
Estimated PCD
2024-10-31
Trial end
2024-12-31
Status
Not yet recruiting
Treatment
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.
Arms:
Buyang Huanwu Decoction group
Placebo
90% starch and 10% Buyang Huanwu Decoction
Arms:
Placebo group
Size
60
Primary endpoint
Changes in visual acuity
12 weeks
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2023-09-28

1 organization

1 product

4 indications

Indication
Glaucoma
Indication
Visual Acuity
Indication
Visual Field