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Study on the Safety and Efficacy of Oral L-Arginine Supplementation in the Treatment of Thyroid-Associated Ophthalmopathy: A Multicenter Randomized Controlled Trial

Study on the Safety and Efficacy of Oral L-Arginine Supplementation in the Treatment of Thyroid-Associated Ophthalmopathy: A Multicenter Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114267
Enrollment
Unknown
Registered
2025-12-09
Start date
2026-01-01
Completion date
Unknown
Last updated
2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid eye diseas

Interventions

control group:placebo
experimental group:L-arginine supplementation

Sponsors

Eye Hospital, Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 30-60 years old, regardless of gender; 2. TAO patients with MD value 4.8; 4. At least one eye has abnormal Qcsf; 5. In good physical condition and able to meet follow-up requirements; 6. After fully understanding the safety of the research project, willing to actively cooperate with the research and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with ocular diseases that may affect visual function, such as corneal ulcer, cataract, retinal vascular disease, retinal detachment, and other optic nerve diseases; 2. Patients with acute TAO and those with incomplete eyelid closure; 3. History of brain tumor, brain trauma, or cerebrovascular disease; 4. History or family history of neurological disease or mental illness; 5. Patients with poorly controlled diabetes or severe systemic diseases such as severe heart, liver, or renal insufficiency; 6. Exclusion of orbital apex crowding by MRI/HRCT examination; 7. Women who are pregnant, lactating, or have plans to become pregnant within the past six months.

Design outcomes

Primary

MeasureTime frame
Retinal capillary density;visual acuity;qCSF;

Secondary

MeasureTime frame
Blood glucose, glycated hemoglobin, blood lipid profile, arginine metabolism profile;Orbital Imaging;clinical activity score;exophthalmos;blood pressure;ocular pressure;visual field;

Countries

China

Contacts

Public ContactYunhai Tu

Eye Hospital, Wenzhou Medical University

tyh5@21cn.com+86 577 8806 8861

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026