A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Assessing Efficacy and Safety of a Novel Low-Dose Turmeric Extract Formulation in Healthy Adults with Chronic Knee Pain.

biomarkers chronic pain curcuminoids knee joint turmeric visual analog scale

Journal

Clinical pharmacology : advances and applications
ISSN: 1179-1438
Titre abrégé: Clin Pharmacol
Pays: New Zealand
ID NLM: 101564865

Informations de publication

Date de publication:
2021
Historique:
received: 26 02 2021
accepted: 24 03 2021
entrez: 28 5 2021
pubmed: 29 5 2021
medline: 29 5 2021
Statut: epublish

Résumé

Knee pain causes functional limitations, eventually compromising the quality of life. We evaluated the efficacy of our water-dispersible turmeric formulation (60% natural curcuminoids, TurmXTRA 60N In this randomized, double-blind, placebo-controlled trial, subjects received either 250 mg WDTE60N capsule (150 mg curcuminoids; n = 53) or appearance-matched placebo capsule (n = 53) once daily for 90 days. Primary endpoint was change in pain score on the visual analogue scale (VAS) after 80-m fast-paced walk test. A total of 96 subjects completed the study. WDTE60N reduced VAS score from baseline (5.4 ± 0.9) to day 90 (3.8 ± 0.8) with greater mean reduction than placebo (-1.5 ± 0.7 vs -0.6 ± 0.8, WDTE60N 250 mg administered once daily for 3 months, alleviated knee pain, improved joint function in healthy subjects with chronic knee pain, was well tolerated and safe.

Sections du résumé

BACKGROUND BACKGROUND
Knee pain causes functional limitations, eventually compromising the quality of life. We evaluated the efficacy of our water-dispersible turmeric formulation (60% natural curcuminoids, TurmXTRA 60N
METHODS METHODS
In this randomized, double-blind, placebo-controlled trial, subjects received either 250 mg WDTE60N capsule (150 mg curcuminoids; n = 53) or appearance-matched placebo capsule (n = 53) once daily for 90 days. Primary endpoint was change in pain score on the visual analogue scale (VAS) after 80-m fast-paced walk test.
RESULTS RESULTS
A total of 96 subjects completed the study. WDTE60N reduced VAS score from baseline (5.4 ± 0.9) to day 90 (3.8 ± 0.8) with greater mean reduction than placebo (-1.5 ± 0.7 vs -0.6 ± 0.8,
CONCLUSION CONCLUSIONS
WDTE60N 250 mg administered once daily for 3 months, alleviated knee pain, improved joint function in healthy subjects with chronic knee pain, was well tolerated and safe.

Identifiants

pubmed: 34045905
doi: 10.2147/CPAA.S307464
pii: 307464
pmc: PMC8149286
doi:

Types de publication

Journal Article

Langues

eng

Pagination

91-100

Commentaires et corrections

Type : ErratumIn

Informations de copyright

© 2021 Thanawala et al.

Déclaration de conflit d'intérêts

Shefali Thanawala and Rajat Shah are employees of Inventia Healthcare Ltd. KrishnaRaju Venkata Alluri and Venkateswarlu Somepalli are employees of Laila Nutraceuticals. Prabakaran Desomayanandam and Arun Bhuvanendran are employees of In Vitro Research Solutions (iVRS) Pvt Ltd. The authors do not have any other conflicts of interest to declare.

Références

Am Fam Physician. 2009 Dec 15;80(12):1371-8
pubmed: 20000300
J Pain Res. 2018 Apr 26;11:851-856
pubmed: 29731662
J Nat Prod. 2007 Feb;70(2):143-6
pubmed: 17315954
Front Immunol. 2018 Apr 13;9:754
pubmed: 29706967
J Tradit Complement Med. 2016 Sep 09;7(3):339-346
pubmed: 28725630
Osteoarthritis Cartilage. 2012 Apr;20(4):271-8
pubmed: 22273632
Evid Based Complement Alternat Med. 2020 May 10;2020:7656919
pubmed: 32454872
Arthritis Res Ther. 2016 Dec 12;18(1):291
pubmed: 27955699
Arthritis Rheumatol. 2020 Nov;72(11):1916-1927
pubmed: 32755051
Open Access Rheumatol. 2013 Jul 29;5:69-76
pubmed: 27790025
Adv Pharmacol Sci. 2016;2016:9130979
pubmed: 27247570
Rheumatology (Oxford). 2000 Sep;39(9):955-61
pubmed: 10986299
J Med Food. 2016 Aug;19(8):717-29
pubmed: 27533649
Osteoarthritis Cartilage. 2013 Sep;21(9):1145-53
pubmed: 23973124
Nutr J. 2013 Nov 25;12(1):154
pubmed: 24274358
Cancer Chemother Pharmacol. 2012 Jan;69(1):65-70
pubmed: 21603867
Am Fam Physician. 2015 Nov 15;92(10):875-83
pubmed: 26554281
Inflamm Res. 2009 Dec;58(12):899-908
pubmed: 19579007
J Pharmacol Sci. 2009 Sep;111(1):13-21
pubmed: 19763044
J Orthop Surg Res. 2015 Feb 03;10:24
pubmed: 25645576
Osteoarthritis Cartilage. 2012 Dec;20(12):1548-62
pubmed: 22944525
Osteoarthritis Cartilage. 2013 Aug;21(8):1042-52
pubmed: 23680877
Br J Sports Med. 2018 Feb;52(3):167-175
pubmed: 29018060
Arthritis Res Ther. 2018 Nov 06;20(1):250
pubmed: 30400973
Osteoarthritis Cartilage. 2010 Nov;18(11):1441-7
pubmed: 20816981
Matrix Biol. 2002 Apr;21(3):251-62
pubmed: 12009331
J Behav Med. 2007 Feb;30(1):77-94
pubmed: 17180640
Curr Opin Rheumatol. 2011 Sep;23(5):471-8
pubmed: 21788902
Nutrients. 2017 Apr 21;9(4):
pubmed: 28430129
J Drug Target. 2016 Sep;24(8):694-702
pubmed: 26942997
Int J Mol Sci. 2016 Dec 06;17(12):
pubmed: 27929434
Am J Manag Care. 2013 Nov;19(14 Suppl):s267-72
pubmed: 24494609
Trends Immunol. 2012 Nov;33(11):571-7
pubmed: 22883707
Semin Arthritis Rheum. 2018 Dec;48(3):416-429
pubmed: 29622343
Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52
pubmed: 22588748
Osteoarthritis Cartilage. 2011 Jan;19(1):1-21
pubmed: 21035558
Ann Rheum Dis. 2014 Jul;73(7):1369-75
pubmed: 23716068
J Orthop Sci. 2014 Nov;19(6):933-9
pubmed: 25308211
Int J Rheum Dis. 2017 Apr;20(4):420-433
pubmed: 28470851
Arthritis Res Ther. 2016 Sep 13;18(1):202
pubmed: 27623622
Int J Med Sci. 2019 Jun 2;16(6):845-853
pubmed: 31337958
Aging Dis. 2018 Feb 1;9(1):143-150
pubmed: 29392089
J Nat Prod. 2011 Apr 25;74(4):664-9
pubmed: 21413691
World J Orthop. 2015 Jan 18;6(1):95-105
pubmed: 25621214
Antioxidants (Basel). 2020 Jun 10;9(6):
pubmed: 32532064
Rev Bras Reumatol Engl Ed. 2017 May - Jun;57(3):229-237
pubmed: 28535895
Osteoarthritis Cartilage. 2015 Aug;23(8):1233-41
pubmed: 25865392
J Exp Orthop. 2018 Jun 15;5(1):21
pubmed: 29904905
Nutr J. 2014 Jan 24;13:11
pubmed: 24461029
JBJS Rev. 2019 Aug;7(8):e5
pubmed: 31415278
Rheumatology (Oxford). 2004 Jan;43(1):55-61
pubmed: 12923283
ISRN Family Med. 2013 Dec 26;2013:930825
pubmed: 24959577
Aust Prescr. 2015 Aug;38(4):115-9
pubmed: 26648637

Auteurs

Shefali Thanawala (S)

Inventia Healthcare Ltd., Mumbai, Maharashtra, India.

Rajat Shah (R)

Inventia Healthcare Ltd., Mumbai, Maharashtra, India.

Venkateswarlu Somepalli (V)

Laila Nutraceuticals, Vijayawada, Andhra Pradesh, India.

KrishnaRaju Venkata Alluri (KV)

Laila Nutraceuticals, Vijayawada, Andhra Pradesh, India.

Prabakaran Desomayanandam (P)

In vitro Research Solutions (iVRS) Pvt Ltd, Bengaluru, Karnataka, India.

Arun Bhuvanendran (A)

In vitro Research Solutions (iVRS) Pvt Ltd, Bengaluru, Karnataka, India.

Classifications MeSH