Effect of hydroxychloroquine therapy in new-onset type 1 diabetes

Phase 3

• Conditions: Health Condition 1: O- Medical and SurgicalHealth Condition 2: E109- Type 1 diabetes mellitus without complications

• Registration Number: CTRI/2022/08/044961
• Lead Sponsor: Post Graduate Institute of Medical Education and Research PGIMER Chandigarh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 25 July 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Patients with type 1 diabetes mellitus between 8 and 18 years. AND

2.Detected to have type 1 diabetes mellitus in the last 100 days. AND

3.Informed consent for the study given by parent or a legal guardian.

Exclusion Criteria

Patients with any one of the following will be excluded:

1.Those children who were already started on hydroxychloroquine for a different indication

2.Those who had history of any serious adverse effects/ acute drug reaction after initiation of hydroxychloroquine in the past

3.Patients on medications which can cause drug interactions with hydroxychloroquine

4.Past history of hemolysis due to deficiency of G6PD

5.Proven retinal disease in the past

6.Prolonged QT interval or other known cardiac diseases

7.Any active infections

8.White blood cell counts less than 3000 leukocytes per microlitre, Platelets below 1,25,000/micro litre, absolute neutrophil count below 1500 per micro litre

9.Liver dysfunction (jaundice, elevated alanine aminotransferase or aspartate aminotransferase for more than a week at the time of enrolment)

10.Renal dysfunction

11.Any ECG abnormality

Study & Design

• Study Type: Interventional
• Study Design: Not specified