Safety of NR-INF-02, an Extract of Curcuma Longa Containing Turmerosaccharides, in Healthy Volunteers: A Randomized, Open-label Clinical Trial.

Turmeric (Curcuma longa) is a common medicinal plant used in traditional medicine that also has been scientifically validated for its antioxidant, anti-arthritic, anticancer, analgesic, and anti-inflammatory properties. Researchers have still not much explored the beneficial effects of the curcuminoid-free portion of turmeric. NR-INF-02 is a proprietary, patented aqueous extract of Curcuma longa comprising turmerosaccharides with a novel phytochemical composition. The study intended to evaluate the safety and tolerability of NR-INF-02 in healthy adult volunteers at doses of 1000 and 2000 mg, administered for 84 days. The study employed a randomized, open label, two-arm, parallel-group design. The trial was carried at 2 sites, the Meenakshi Multispecialty Hospital in Chennai, Tamil Nadu, India and the Vijaya Super Specialty Hospital in Nellore, Andhra Pradesh, India. Participants were healthy adult, male or female volunteers, aged 18-65 years with a body mass index of ≥18.5 kg/m2 and ≤ 24.9 kg/m2 and a body weight of at least 55 kg for men and 48 kg for women. Participants were randomly divided into 2 groups with 24 participants each for a total of 48 participants. They received either 1000 or 2000 mg of NR-INF-02 for 84 days. The incidence of adverse events and the changes from baseline in clinical laboratory parameters-including hematological, biochemical, and urinalysis parameters-were assessed at baseline, at day 42, and postintervention at day 84 as primary endpoints for safety. Secondary endpoints were the changes in vital signs and the difference in the results of an electrocardiogram (ECG) between baseline and days 42 and 84. The NR-INF-02 at doses of 1000 and 2000 mg demonstrated a 4.17% and 20.83% incidence of adverse events (AEs), respectively. The AEs were mild to moderate and were either probably or possibly related, but not definitively, related to treatment. A detailed examination of hematological, biochemical, and urological parameters and of ECG results and vital signs didn't indicate any untoward effects for any participant. The study found NR-INF-02 to be safe and tolerable at both tested doses for the given duration of the trial for healthy adult volunteers.