PMID- 32827412
OWN - NLM
STAT- MEDLINE
DCOM- 20220216
LR  - 20220501
IS  - 1078-6791 (Print)
IS  - 1078-6791 (Linking)
VI  - 28
IP  - 2
DP  - 2022 Feb
TI  - Safety of NR-INF-02, an Extract of Curcuma Longa Containing Turmerosaccharides, 
      in Healthy Volunteers: A Randomized, Open-label Clinical Trial.
PG  - 116-123
LID - AT6360 [pii]
AB  - CONTEXT: 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. OBJECTIVE: 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. DESIGN: The study employed a randomized, open 
      label, two-arm, parallel-group design. SETTING: 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: 
      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. INTERVENTION: 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. OUTCOME MEASURES: 
      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. RESULTS: 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. CONCLUSION: 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.
FAU - Selvi, M
AU  - Selvi M
FAU - Mohan Mv, Rama
AU  - Mohan Mv R
FAU - Bethapudi, Bharathi
AU  - Bethapudi B
FAU - Mundkinajeddu, Deepak
AU  - Mundkinajeddu D
FAU - Kumari, Swati
AU  - Kumari S
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - United States
TA  - Altern Ther Health Med
JT  - Alternative therapies in health and medicine
JID - 9502013
RN  - 0 (Anti-Inflammatory Agents)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Anti-Inflammatory Agents
MH  - *Curcuma
MH  - Healthy Volunteers
MH  - Humans
MH  - India
MH  - Middle Aged
MH  - *Plants, Medicinal
MH  - Young Adult
EDAT- 2020/08/23 06:00
MHDA- 2022/02/17 06:00
CRDT- 2020/08/23 06:00
PHST- 2020/08/23 06:00 [pubmed]
PHST- 2022/02/17 06:00 [medline]
PHST- 2020/08/23 06:00 [entrez]
AID - AT6360 [pii]
PST - ppublish
SO  - Altern Ther Health Med. 2022 Feb;28(2):116-123.