Clinical trial
Study on Efficacy of Add on Selenium in Mild-to-moderate Graves Ophthalmopathy: A Randomized Control Trial
Name
PG Thesis/2023-24/122
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.
Trial arms
Trial start
2024-05-06
Estimated PCD
2025-08-05
Trial end
2025-11-05
Status
Not yet recruiting
Treatment
Selenium
Add on Selenium (100mcg once daily) with Vitamin B Complex and Standard Treatment for Grave's Disease
Arms:
ADD on Selenium
Size
78
Primary endpoint
To evaluate and compare the response of add on selenium in patients with grave's ophthalmopathy
90 Days
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 78, 'type': 'ESTIMATED'}}
Updated at
2024-05-14
1 organization