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A comparison of radioactive iodine therapy versus anti-thyroid drugs as initial treatment for Graves disease

A randomized clinical trial to compare the safety and efficacy of Radioiodine ablation as initial treatment modality versus conventional antithyroid drug therapy for Gravesâ?? disease - RIOT (Radioiodine as Initial Option in Treatment)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/03/006728
Enrollment
90
Registered
2016-03-11
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Graves Disease (Hyperthyroidism)

Interventions

Intervention1: RadioActive Iodine (I131): Iodine 131 ( I131) 10 mCi Control Intervention1: AntiThyroid Drugs ( Carbimazole/ PropylThiouracil): Carbimazole (Initial dose 30mg/day)/Propylthiouracil (Ini

Sponsors

Department of Internal Medicine
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult males or females, >18yr age with a diagnosis of Gravesâ?? disease ( Hyperthyroidism) Gravesâ?? disease (Hyperthyroidism) defined as raised T4 and/or T3, low TSH with or without hypermetabolic symptoms, diffuse goiter and diffuse increased uptake on Tc99m Pertechnate scan ( >4%)

Exclusion criteria

Exclusion criteria: Pregnancy/planning pregnancy in next 01 yr, use of Antithyroid drugs, iodine containing drugs, Multinodular goiter, thyroid malignancy/suspicious nodules, significant eye disease, Refusal to give consent

Design outcomes

Primary

MeasureTime frame
Remission rate ( Attainment of Euthyroid/hypothyroid status at 01 yr after therapy withdrawal)Timepoint: Remission rate ( Attainment of Euthyroid/hypothyroid status at 01 yr after therapy withdrawal)—

Secondary

MeasureTime frame
1. Relapse/treatment failure (hyperthyroidism within 02 yr after attainment of euthyroid/hypothyroid status), 2. thyroid storm (diagnosed clinically based on Burch and Wartofsky scoring) 3. thyroiditis (Thyrotoxicosis with low uptake on Pertechnate scan) during/ immediate post treatment 4.worsening of eye diseaseTimepoint: 2yrs—

Countries

India

Contacts

Public ContactCol Dr J Muthukrishnan

Armed Forces Medical College

jmuthukrishnan@hotmail.com8698951237

Outcome results

None listed

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