A Clinical Study Phase II of Ginger Extract in Nanostructured Lipid Carrier for Pain Relief in Knee Osteoarthritis Patients

Main Article Content

Punyanut Amorndoljai
Surasak Taneepanichskul
Sunyarn Niempoog
Ubonthip Nimmannit

Abstract

Introduction: Herbal medicines are used extensively in patients with chronic pain such as
osteoarthritis (OA). There are few clinical trials to proof their effi cacy and safety. This study was
undertaken to examine the effi cacy and safety of ginger (Zingiber offi cinale Roscoe) extract in
Nanostructured Lipid Carrier (NLC) for relieving pain in knee OA patients. NLC is popular formulation
of the topical herbal medicines. Methods: Twenty patients (3 males and 17 females aged range of
50-75 years who diagnosed as OA knee. This diagnosis is based on the American College of
Rheumatology (ACR) diagnosis criteria. All participants received a treatment with ginger extract in NLC
rubbed three times a day for 4 weeks. Effi cacy was assessed by the Western Ontario and McMaster
Universities Arthritis Index (WOMAC), Knee Injury and Osteoarthritis Outcome Score (KOOS) and
patient’s global assessment (PGA). The safety of ginger extract in NLC was approved by biochemical
tests in serum and hematological parameters. The paired t-test was used to compare the average
score of effi cacy before and after treatment. Results: Ginger extract in NLC revealed its statistically
signifi cant improvement in patient’s global assessment, knee joint pain, physical function, stiffness,
symptom, sport & recreation activity and quality of life which measured by PGA, WOMAC and KOOS.
Within 4-week treatment with ginger extract in NLC, there were 2 reports of contact dermatitis adverse
event. Conclusion: A 4-week treatment with ginger extract in NLC could relieve joint pain and improve
problematic symptoms and the quality of life in knee osteoarthritis patients.

Downloads

Download data is not yet available.

Article Details

Section
Research Articles

References

Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, et al. Development of criteriafor the classifi cation and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Arthritis Rheum (1986): 29: 1039-49.

Altman RD. Early management of osteoarthritis. Am J Manag Care; 16 Suppl Management: S41-7, (2010).

American college of rheumatology subcommittee on rheumatoid arthritis guidelines. Guidelines for the management of rheumatoid arthritis. Arthritis Rheum. (2002): 46(2): 328-46.

Anonymous. Zingiberoffcinale (ginger). Alternative Med. Rev. (2003) 8, 331–335.

Bellamy N, Kirwan J, Boers M, Brooks P, Strand V, Tugwell P, Altman R, Brandt K, Dougados M, Lequesne M: Recommendations for a core set of outcome measures for future phase III clinical trials in knee, hip, and hand osteoarthritis. Consensus development at OMERACT III. J Rheumatol 1997, 24: 799-802.

Bliddal H, Christensen R. The treatment and prevention of knee osteoarthritis: a tool for clinical decision-making. Expert OpinPharmacother (2009); 10: 1793-804.

Chaipinyo K. Osteoarthritis Outcome Scores (KOOS) Thai version Test-Retest Reliability and Construct Validity of the Thai Version of Knee Osteoarthritis Outcome Scores (KOOS). Thai Journal of Physical Therapy. (2009) Vol. 31 No. 2

Chrubasik, S., Pittler, M.H., Roufogalis, B.D. Zingiberisrhizoma: a comprehensive review on theginger effect and efficacy profiles. Phytomedicine 12(2005): 684–701.

Grazio S, BalenD. Obesity: Risk factor and predictors of osteoarthritis, (2009); 131: 22-6.

Kapstad, K., Rustoen, T., Hanestad, B.R., Moum, T., Langeland, N., & Stavem, K. Changes in pain, stiffness and physical function in patients with osteoarthritis waiting for hip or knee join replacement surgery. The Norwegian System of Compensation to Patients. Faculty of Nursing Education. Oslo University College. Oslo, Norway, (2007).

Kellgren JH, Lawrence JS. Radiological assessment of osteoarthritis. Ann Rheum Dis 1957; 16: 494502.

Kuptniratsaiku lV., Rattanachaiyanont M. Validation of a modified Thai version of the Western Ontario and McMaster (WOMAC) osteoarthritis index for knee osteoarthritis. Clin Rheumatol (2007) 26: 1641–1645.

Lequesne MG, Mery C, Samson M, Gerard P Indexes of severity for osteoarthritis of the hip and knee. Scand J Rheumatoid65(Suppl) (1987): 85–89.

Levy, A.S., Simon, O., Shelly, J., Gardener, M. 6-Shogaol reduced chronic inflammatory response in the knees of rats treated with complete Freund’s adjuvant. BMC Pharmacology, (2006). 6, 12.

Levy, A.S., Simon, O.R., Six-shogaol inhibits production of tumour necrosis factor alpha, interleukin-1 beta and nitric oxide from lipopolysaccharide-stimulated RAW 264. 7 macrophages. The West Indian Medical Journal, (2009). 58, 295–300.

Mascolo N, Jain R, Jain SC, Capasso F. Ethnopharmacologic investigation of ginger (Zingiberoffi cinale). J Ethnopharmacol. 27(1/2) (1989):129-40.

Michel, D. J., Knodel, L. C. Comparison of three algorithms used to evaluate adverse drug reactions, American Journal of Hospital Pharmacy, (1986) 43: 1709–1714.

Mustafa T, Srivastava K C. Ginger (Zingiberofticinale) in migraine headache. Journal of Ethnopharmacology 29: 267-273, 1998.

Niempoog, S., P. Siriarchavatana and T. Kajsongkram. The efficacy of Plygersic gel for use in the treatment of osteoarthritis of the knee. J Med Assoc Thai. 95 Suppl 10(2012): S113-9.

Pham T, van der Heijde D, Altman RD, Anderson JJ, Bellamy N, Hochberg M, Simon L, Strand V, Woodworth T, Dougados M: OMERACT-OARSI initiative: Osteoarthritis Research Society International set of responder criteria for osteoarthritis clinical trials revisited. Osteoarthritis Cartilage 2004, 12:389-399.

Philip A, Lisa M and Zev Shainhouse. Treatment of osteoarthritis of the knee with a topical diclofenac solution: a randomized controlled, 6-week trial. BMC Musculoskeletal Disorders 2005, 6:44 doi:10. 1186/1471-2474-6-44

Praditbongkotchp A. Formulation of Microemulsion gel of Zingiberofficinale Roscoe Extract Evaluation of Anti-inflammatory activity in rats. Master of Science Faculty of Pharmaceutical Science Chulalongkorn University, (2010).

Roos EM and Toksvig-Larsen S: Knee injury and Osteoarthritis Outcome Score (KOOS) validation and comparison to the WOM-AC in total knee replacement. Health Qual Life Outcomes (2003): 1:17.

Shibata, M. Ohkubo, T Takahashi, H. and Inoki, R. Modified formalin test: characteristic biphasic pain response. Pain (1989) 38: 347-352.

Thai version of KOOS [Internet]. 2009 [cited 2014Feb 15]. Available from: http://www.koos.nu/ThaiKOOS.pdf

Thomson, M., Al-Qattan, K.K., Al-Sawan, S.M., Alnaqeeb, M.A., Khan, I., Ali, M., The use of ginger (Zingiber offcinale Rosc.) as a potential anti-infl ammatory and antithrombotic agent; Prostaglandins Leukot. Essent. Fatty Acid (2002) 67, 475–478.