The Effect of a New Antioxidant Combination (ASTED) on Moderate to Severe Thyroid Eye Disease
Thyroid Eye Disease
About this trial
This is an interventional treatment trial for Thyroid Eye Disease focused on measuring Graves' ophthalmopathy, Antioxidant, Activity, Severity
Eligibility Criteria
Inclusion Criteria:
- Moderate to severe TED of less than 18 months duration:
- Active state (Clinical activity score of 3 and more).
- No steroid and or any supplement treatment for the last 6 months.
- Euthyroidism
- Age 18-70 years.
Exclusion Criteria:
- Sight-threatening TED
- Pregnancy
- Drug and/or alcohol abuse
- Severe concomitant illness
- Inability to comply with the study protocol
- No informed consent
- Developing more severe TED (Sight threatening TED) in the course of the trial.
- Contraindications of steroid treatment.
Sites / Locations
- Private Thyroid eye disease clinic
- Rassoul Akram Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Methylprednisolone + ASTED
Methylprednisolone + Placebo
ASTED (Antioxidant Supplements for Thyroid Eye Disease) includes : B-Carotene (6 mg)+ Vit.C (200 mg) + Vit.E (200 mg) + Nicotinamide(20mg) + Selenium(200mic.) + Zinc oxide (8 mg) + Copper gluconate or oxide (1mg) + Manganese chloride (1.8 mg), Twice a day for 6 months Methylprednisolone includes : Methylprednisolone tablet of 50 and 5 mg, company….) 1mg/kg for the first 2 weeks, 0.8mg/kg for 2 weeks, 0.7 mg/kg for 2 weeks, and then tapering off the methylprednisolone in 6 weeks (total duration of 12 weeks) by 8-10 mg per week. For example, a patient with 75 kg weight will receive 75 mg for 2 weeks, 60 mg for 2 weeks, 52.5 mg for 2 weeks, and then decreasing by 8-10 mg per week for 6 weeks. The dose regiment will be written and handed to the patient on the first visit and will be monitored during the follow up.
Placebo Twice a day for 6 months Methylprednisolone prescribes as the same as arm 1