Open Access Journal of Clinical Trials
Open access peer-reviewed scientific and medical journals.
Dove Medical Press is now a member of the Open Access Initiative
An Author's Guide
A guide to help authors get their paper published.
Support Open Access and Dove Press
Promotional Article Monitoring - further details
Favored Author Program
Real benefits for authors, including fast-track processing of papers.
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
(5506) Total Article Views
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
|Received:||23 December 2011|
|Accepted:||15 February 2012|
|Published:||26 April 2012|
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
Cannotea Citeulike Del.icio.us Facebook LinkedIn Twitter
Readers of this article also read:
"I was impressed at the rapidity of publication from submission to final acceptance." Dr Edwin Thrower, PhD, Yale University.
- The benefits and risks of testosterone replacement therapy: a review
- Enzalutamide: an evidence-based review of its use in the treatment of prostate cancer
- Tumor necrosis factor-alpha inhibitor treatment for sarcoidosis
- Tenofovir-associated bone density loss