ICMR-National Institute Of Malaria Research Gets CDSCO Panel Nod To Study Curcumin
New Delhi: In a significant development, the ICMR (Indian Council of Medical Research)- the National Institute of Malaria Research has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the clinical trial of Curcumin (Biocurcumax).
However, this approval is subject to the condition that the firm should submit the outcome of most unexpected adverse events and methods for evaluation for parasitic clearance.
This came after the firm presented Phase IIa clinical trial protocol No. NIMR- Ipca/ARCU/PIIa-16.
Curcumin is a diarylheptanoid, belonging to the group of curcuminoids, which are phenolic pigments responsible for the yellow color of turmeric.
Research suggests that curcumin, a polyphenolic organic molecule derived from turmeric, inhibits chloroquine-resistant Plasmodium falciparum growth in culture in a dose-dependent manner with an IC(50) of approximately 5 microM. Additionally, oral administration of curcumin to mice infected with the malaria parasite (Plasmodium berghei) reduces blood parasitemia by 80-90% and enhances their survival significantly. Thus, curcumin may represent a novel treatment for malarial infection.
Curcumin can suppress the acute and chronic inflammation. It reduces inflammation by lowering histamine levels and possibly increasing the production of natural cortisone by adrenal glands. Additionally, in vitro studies of curcumin showed anti-inflammatory action on human vascular cells.
At the recent SEC meeting for antimicrobial and antiviral held on 21st December 2023, the expert panel reviewed the Phase IIa clinical trial protocol No NIMR-Ipca/ARCU/PIIa-16.
After detailed deliberation, the committee recommended the grant of permission to conduct the clinical trial as presented by the applicant with the condition that the following shall be submitted to CDSCO:
1. Outcome of most unexpected adverse events.
2. Methods for evaluation for parasitic clearance.
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