CDSCO panel directs Themis Medicare to conduct blinded trial of Inosine Pranobex in Moderate Covid-19 patient
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organisation (CDSCO) recently recommended Themis Medicare to conduct a Phase 3 blinded trial of Inosine pranobex in moderate COVID-19 patients.
A blinded (or masked) clinical trial is a field study of a drug in which the recipient does not know if he is receiving the actual drug versus a placebo. A double-blind clinical trial is one in which both the recipient and the administrator does not know if the recipient is receiving the actual drug.
The CDSCO Committee further asked the firm to submit a revised protocol regarding the same.
This came following a proposal by the drugmaker to conduct Phase III Clinical trial protocol for Inosine Pranobex.
Inosine pranobex is an antiviral drug made out of the combination of inosine and dimepranol acedoben in a ratio of 1 to 3. The drug is also known as inosine acedoben dimepranol or methisoprinol. Although the drug itself doesn't have any effect on viral particles it helps to stimulate the immune system. Its common usage includes the treatment of rare measles complication subacute sclerosing panencephalitis in conjunction with intrathecal interferon therapy.
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