Tauroursodeoxycholate + Traditional Chinese Medicine for Diabetic Macular Edema
What You Need to Know Before You Apply
What is the purpose of this trial?
Diabetic macular edema is seen in the later stages of diabetic retinopathy with current conventional therapies targeting local vascular dysfunction. These therapies provide transient improvement in vision and are often uncomfortable to persons with diabetic macular edema and financially burdensome. Diabetic macular edema, a complication of diabetes cannot be managed without addressing systemic inflammation. Liver metabolism and functions are implicated in diabetes and evidence suggests that hepatic metabolic dysfunctions are linked to the neuroinflammation and vascular dysfunctions observed in diabetic retinopathy. Nutraceutical supplements like Tauroursodeoxycholate (a bile acid) and modified Qi Ju Di Huang Wan (a traditional Chinese medicine formula) have been found to reduce hepatic and retinal oxidative stress, provide anti-apoptotic, anti-inflammatory, neuroprotective and hepatoprotective effects. This study will provide a non-invasive multi-targeted strategy for the management of diabetic macular edema.
Who Is on the Research Team?
Maria Grant, MD
Principal Investigator
University of Alabama at Birmingham
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either mQJDHW capsules, TUDCA supplements, or placebo twice daily for six months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Tauroursodeoxycholate (TUDCA)
- Traditional Chinese Medicine (mQJDHW)
How Is the Trial Designed?
3
Treatment groups
Active Control
Placebo Group
Participants in this arm will be administered a standard dose of mQJDHW capsules twice daily for six months. mQJDHW, is a popular traditional Chinese medicine (TCM) formula used by TCM practitioners for managing eye diseases. It has been found to improve ocular health in anterior chamber diseases, uveitis, optic neuropathies and diabetic retinopathy. The various components of this formula, Tribulus terrestris, Paeonia lactiflora, Lycium chinensis, Angelica sinensis, Chrysanthemum morifolium, Paeonia suffruticosa, Dioscorea japonica, Cornus officinalis, Rehmannia glutinosa, Haliotis spp, Alisma plantago-aquatica and Dioscorea oppositifolia, have been found to provide neuroprotection, hepatoprotection, and reduce oxidative stress and neuroinflammation. Available in literature is evidence of the beneficial roles of this formula to systemic and retinal health.
TUDCA is a bile acid that is available as a supplement. It has been found to provide protection in neuroinflammatory and neurodegenerative diseases. Evidence links it to reducing retinopathy in pre-clinical studies.
Participants will receive capsules with no active ingredient twice daily for six months.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor
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