Study on Efficacy of Add on Selenium in Mild-to-moderate Graves Ophthalmopathy

All India Institute of Medical Sciences, Bhubaneswar

Status

Not yet enrolling

Conditions

Graves Ophthalmopathy

Thyroid Eye Disease

Treatments

Drug: Selenium

Study type

Interventional

Funder types

Other

Identifiers

NCT06413043

PG Thesis/2023-24/122

Details and patient eligibility

About

The Study on efficacy of add on selenium in mild-to-moderate Graves ophthalmopathy: A Randomized Control Trial.; The study aims to evaluate the response of adding selenium in patients with Graves ophthalmopathy, focusing on improving quality of life, CAS scoring, and thyroid status. The methodology involves a Randomized Control Trial with a sample size of 78 patients. Patients meeting specific criteria will receive either standard treatment with Anti Thyroid Drugs and Vitamin B complex or add on selenium with Vitamin B complex for 6 months. Outcome measures include CAS score reduction, thyroid function improvement, and quality of life enhancement. The study will last 18 months, with various investigations and ethical considerations outlined. The document emphasizes the importance of early diagnosis of Graves Ophthalmopathy to prevent vision loss and deformity, highlighting the significance of informed patients and healthcare professionals regarding TED symptoms and risk factors.

Full description

The Study on efficacy of add on selenium in mild-to-moderate Graves ophthalmopathy: A Randomized Control Trial. The study aims to evaluate the response of adding selenium in patients with Graves ophthalmopathy, focusing on improving quality of life, CAS scoring, and thyroid status. The methodology involves a Randomized Control Trial with a sample size of 78 patients. Patients meeting specific criteria will receive either standard treatment with Anti Thyroid Drugs and Vitamin B complex or add on selenium with Vitamin B complex for 6 months. Outcome measures include CAS score reduction, thyroid function improvement, and quality of life enhancement. The study will last 18 months, with various investigations and ethical considerations outlined. The document emphasizes the importance of early diagnosis of Graves Ophthalmopathy to prevent vision loss and deformity, highlighting the significance of informed patients and healthcare professionals regarding TED symptoms and risk factors.

Enrollment

78 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with Mild-to-moderate Grave's Ophthalmopathy in Age group >18years

With only one or more :

Retraction of lid <2 mm
Mild soft tissue involvement
Proptosis of <=3 mm
Corneal exposure that responds to lubricating eyedrops.
Patients with CAS < = 4
Patients diagnosed with hyperthyroidism converted to euthyroid since 2 months with Anti Thyroid Drugs.
Those who are willing to follow the advised treatment and timely follow ups.

Exclusion criteria

Treatment with any steroid (Intravenous, oral or topical) for any condition within 3 weeks before presentation.
Any treatment with rituximab
Any earlier treatment with teprotumumab.
Any treatment with monoclonal antibody within 3months before presentation.
Lactating or pregnant women