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
Shefali Thanawala,1 Rajat Shah,1 Venkateswarlu Somepalli,2 KrishnaRaju Venkata Alluri,2 Prabakaran Desomayanandam,3 Arun Bhuvanendran3 1Inventia Healthcare Ltd., Mumbai, Maharashtra, India; 2Laila Nutraceuticals, Vijayawada, Andhra Pradesh, India; 3In vitro Research Solutions (iVRS) Pvt Ltd, Bengalu...
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Dove Medical Press
2021
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oai:doaj.org-article:8cb8f58fc5d348ee8d4ed0ad2d9c81db2021-12-02T16:51:15ZA 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 Pain1179-1438https://doaj.org/article/8cb8f58fc5d348ee8d4ed0ad2d9c81db2021-05-01T00:00:00Zhttps://www.dovepress.com/a-multicenter-randomized-double-blind-placebo-controlled-trial-assessi-peer-reviewed-fulltext-article-CPAAhttps://doaj.org/toc/1179-1438Shefali Thanawala,1 Rajat Shah,1 Venkateswarlu Somepalli,2 KrishnaRaju Venkata Alluri,2 Prabakaran Desomayanandam,3 Arun Bhuvanendran3 1Inventia Healthcare Ltd., Mumbai, Maharashtra, India; 2Laila Nutraceuticals, Vijayawada, Andhra Pradesh, India; 3In vitro Research Solutions (iVRS) Pvt Ltd, Bengaluru, Karnataka, IndiaCorrespondence: Shefali ThanawalaInventia Healthcare Ltd., Mumbai, Maharashtra, IndiaTel +91 9324210054Email shefali.thanawala@inventiahealthcare.comBackground: 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®—WDTE60N), which exhibited better PK profile at low dose (250 mg) than standard turmeric extract, in alleviating symptoms of chronic knee pain.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: 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, p < 0.0001; 2.5 times). It also significantly improved the time taken for 80-m fast-paced walk test and 9-step stair-climb test; and improved all biomarkers compared to placebo (p > 0.05). Three adverse events occurred but were unrelated to study products.Conclusion: 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.Keywords: biomarkers, chronic pain, curcuminoids, knee joint, turmeric, visual analog scaleThanawala SShah RSomepalli VAlluri KVDesomayanandam PBhuvanendran ADove Medical Pressarticlebiomarkerschronic paincurcuminoidsknee jointturmericvisual analog scaleTherapeutics. PharmacologyRM1-950ENClinical Pharmacology: Advances and Applications, Vol Volume 13, Pp 91-100 (2021) |
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biomarkers chronic pain curcuminoids knee joint turmeric visual analog scale Therapeutics. Pharmacology RM1-950 |
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biomarkers chronic pain curcuminoids knee joint turmeric visual analog scale Therapeutics. Pharmacology RM1-950 Thanawala S Shah R Somepalli V Alluri KV Desomayanandam P Bhuvanendran A 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 |
| description |
Shefali Thanawala,1 Rajat Shah,1 Venkateswarlu Somepalli,2 KrishnaRaju Venkata Alluri,2 Prabakaran Desomayanandam,3 Arun Bhuvanendran3 1Inventia Healthcare Ltd., Mumbai, Maharashtra, India; 2Laila Nutraceuticals, Vijayawada, Andhra Pradesh, India; 3In vitro Research Solutions (iVRS) Pvt Ltd, Bengaluru, Karnataka, IndiaCorrespondence: Shefali ThanawalaInventia Healthcare Ltd., Mumbai, Maharashtra, IndiaTel +91 9324210054Email shefali.thanawala@inventiahealthcare.comBackground: 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®—WDTE60N), which exhibited better PK profile at low dose (250 mg) than standard turmeric extract, in alleviating symptoms of chronic knee pain.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: 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, p < 0.0001; 2.5 times). It also significantly improved the time taken for 80-m fast-paced walk test and 9-step stair-climb test; and improved all biomarkers compared to placebo (p > 0.05). Three adverse events occurred but were unrelated to study products.Conclusion: 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.Keywords: biomarkers, chronic pain, curcuminoids, knee joint, turmeric, visual analog scale |
| format |
article |
| author |
Thanawala S Shah R Somepalli V Alluri KV Desomayanandam P Bhuvanendran A |
| author_facet |
Thanawala S Shah R Somepalli V Alluri KV Desomayanandam P Bhuvanendran A |
| author_sort |
Thanawala S |
| title |
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 |
| title_short |
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 |
| title_full |
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 |
| title_fullStr |
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 |
| title_full_unstemmed |
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 |
| title_sort |
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 |
| publisher |
Dove Medical Press |
| publishDate |
2021 |
| url |
https://doaj.org/article/8cb8f58fc5d348ee8d4ed0ad2d9c81db |
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