Expert Panel Tells IPCA to Revise Hydroxychloroquine Phase III Trial for Diabetes
New Delhi: In response to the proposal presented by IPCA Laboratories Limited, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) opined to revise the protocol of the anti-malarial drug Hydroxychloroquine.
This came after the firm presented the proposal for grant of permission to conduct Phase III clinical trial vide protocol No. Ipca/HYDR/PIII-24, Version: 01, dated 29.07.2024 before the committee for Evaluation of Efficacy and Safety of Hydroxychloroquine in uncontrolled type 2 diabetes patients with Dyslipidemia and Stable Atherosclerotic Cardiovascular Disease.
The committee noted that single primary objective and multiple secondary objectives are mentioned in the Phase III protocol presented by firm.
Hydroxychloroquine is in a class of drugs called antimalarials and is also an antirheumatic drug. It works by killing the organisms that cause malaria. Hydroxychloroquine may work to treat rheumatoid arthritis and systemic lupus erythematosus by decreasing the activity of the immune system.
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.