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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-06

Study Completion Date

2025-11-05

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Thyroid Eye Disease Graves Ophthalmopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ADD on Selenium

Add on Selenium (100mcg once daily) with Vitamin B Complex and Standard Treatment for Grave's Disease

Group Type ACTIVE_COMPARATOR

Selenium

Intervention Type DRUG

Add on Selenium (100mcg once daily) with Vitamin B Complex and Standard Treatment for Grave's Disease

Placebo

Vitamin B Complex supplementation with Standard Treatment for Grave's Disease

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Selenium

Add on Selenium (100mcg once daily) with Vitamin B Complex and Standard Treatment for Grave's Disease

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No