Back to Browse Journals » Open Access Journal of Clinical Trials » Volume 4

Is Patch It® better than placebo in alleviating swelling and ache in the lower legs and feet? A randomized, placebo-controlled, double blind, crossover, sequential trial

Authors Shakeel A, Hui HK, Patil CS, Chaudhari MV, Kadam YD, Pensalwar SV, Erande SG, Kewalramani RM

Published Date April 2012 Volume 2012:4 Pages 21—29

DOI http://dx.doi.org/10.2147/OAJCT.S29426

Received 23 December 2011, Accepted 15 February 2012, Published 24 April 2012

Aliya Shakeel1, Hoong Keong Hui2, Chetan S Patil3, Manojkumar V Chaudhari4, Yogesh D Kadam5, Shrikant V Pensalwar6, Suhas G Erande7, Rajesh M Kewalramani8
1Vedic Lifesciences Pvt Ltd, Mumbai, Maharashtra, India; 2Nutriworks Limited, Kowloon, Hong Kong; 3Muktai Hospital, Nasik, 4Bhagirathi Medical Foundation, 5Poona Diabetes Center, 6Balaji Clinic, Mumbai, 7Akshay Hospital, Pune, 8Shanti Niketan, Kandar Pada, Dahisar, Mumbai, Maharashtra, India

Background: Existing therapeutic measures for swelling, aching and discomfort in the lower limbs, which include compression stockings and leg elevation, are difficult to use and inconvenient. Patch It®, a proprietary herbomineral patch is an easy-to-use alternative therapy. This trial was conducted to compare it's efficacy against that of a placebo in swollen and aching lower legs and feet.
Methods: This randomized, placebo-controlled, double blind, crossover, sequential trial was conducted in the private clinics of physicians. A total of 100 patients (24 men and 76 women), aged 25 to 60 years, with recurring swelling in the feet and (optionally) up to two more related complaints, having an average visual analog score (VAS) of at least 60 (scale 0–100) for each complaint were recruited into the study. Patches (active or placebo) were applied to both soles overnight for 8 weeks: 4 consecutive weeks each with active or placebo in randomized sequence. Outcome measures included the average VAS score (baseline to week 4, and week 5 to week 8), preference for either patch (difference of >5 mm in average VAS score reduction), ankle figure-of-eight measures, investigator's global assessment (good, fair, poor), patient's willingness to continue using the patch after the trial (yes, no), and adverse events.
Results: Out of 100 patients, 86 completed the trial, while ten were excluded for noncompliance, three withdrew, and one was lost to follow-up. The active placebo boundary of the sequential chart was crossed when 82 patients completed the trial. Active patch was also superior to placebo patch by mean reductions in average VAS scores (13.14 versus 9.6, P = 0.02), mean reduction in figure-of-eight ankle measurements (1.21 cm versus 0.79 cm, P = 0.003), investigator's global assessment (P < 0.01), and by proportion of patients willing to continue using the patch after the trial (P < 0.01). Ten percent of patients experienced localized itching with each patch, but this did not require interruption of treatment.
Conclusion: Patch It had greater efficacy than the placebo in alleviating recurring swelling and aching in the legs and feet, and is well tolerated.

Keywords: ankle swelling, leg ache, dermal patch, reflexology, sequential analysis, figure-of-eight

Download Article [PDF] 

Creative Commons License This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution - Non Commercial (unported, v3.0) License. The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. Permissions beyond the scope of the License are administered by Dove Medical Press Limited. Information on how to request permission may be found at: http://www.dovepress.com/permissions.php

Readers of this article also read:

Treatment of localized neuropathic pain after disk herniation with 5% lidocaine medicated plaster

Likar R, Kager I, Obmann M, Pipam W, Sittl R

International Journal of General Medicine 2012, 5:689-692

Published Date: 17 August 2012

Use of select medications prior to duloxetine initiation among commercially-insured patients

Bernauer M, Wu N, Chen SY, Peng X, Boulanger L, Zhao Y

Journal of Pain Research 2012, 5:271-278

Published Date: 14 August 2012

Predictors of duloxetine adherence and persistence in patients with fibromyalgia

Cui Z, Zhao Y, Novick D, Faries D

Journal of Pain Research 2012, 5:193-201

Published Date: 22 June 2012

Update on neuromyelitis optica: natural history and management

Jindahra P, Plant GT

Eye and Brain 2012, 4:27-41

Published Date: 28 March 2012

Doxorubicin-loaded PEG-PCL copolymer micelles enhance cytotoxicity and intracellular accumulation of doxorubicin in adriamycin-resistant tumor cells

Diao YY, Li HY, Fu YH, Han M, Hu YL, Jiang HL, Tsutsumi Y, Wei QC, Chen DW, Gao JQ

International Journal of Nanomedicine 2011, 6:1955-1962

Published Date: 12 September 2011

Adherence and persistence with branded antidepressants and generic SSRIs among managed care patients with major depressive disorder

Xianchen Liu, Yi Chen, Douglas E Faries, et al

ClinicoEconomics and Outcomes Research 2011, 3:63-72

Published Date: 15 March 2011

New and emerging therapeutic agents for the treatment of fibromyalgia: an update

Jill M Recla

Journal of Pain Research 2010, 3:89-103

Published Date: 22 July 2010

Duloxetine for the management of fibromyalgia syndrome

Beth A Scholz, Cara L Hammonds, Chad S Boomershine

Journal of Pain Research 2009, 2:99-108

Published Date: 21 July 2009