International Journal of Science and Healthcare Research Vol.2; Issue: 4; Oct.-Dec. 2017 Website: www.ijshr.com Original Research Article ISSN: 2455-7587 The Effects of Kaempferia Galanga L. Extract on Pain, Stiffness and Functional Physic in Patient with Knee Osteoarthritis: Double Blind Randomized Clinical Trial Akmal Novrian Syahruddin1, Citra Kesumasari Dahlan2, Nurpudji A. Taslim3 1Graduate School Universitas Hasanuddin, 2Department of Nutrition School of Public Health Universitas Hasanuddin, 3Department of Nutrition School of Medicine Universitas Hasanuddin, Jalan Perintis Kemerdekaan Km. 10, PO Box 90245, Makassar, Indonesia. Corresponding Author: Akmal Novarian Syahruddin _____________________________________________________________________________________________________________ ABSTRACT Key words: Kaempferia galanga L.; efficacy; WOMAC index; meloxicam; knee osteoarthritis Background: Osteoarthritis (OA) is a common disease of arthritis and one of the leading causes INTRODUCTION of disability in aged population specially on Knee osteoarthritis (OA) is a knee OA. degenerative joint disease that is most Objectives: This study was to determine the common in old age. Pain is the most effect of Kaempferia galanga L. extracts in pain, common symptom caused by OA and OA is stiffness, and functional improvement in patient expected to finish fourth cause of disability with knee osteoarthritis (OA). [1] Materials and Methods: This study was in old age. OA is a progressive disease Double Blind Randomized Clinical Trial. Fourty characterized by the degeneration of (40) patients with primary knee OA based cartilage and joint tissue changes that result symptom and radiographic (K-L grading OA) in pain, stiffness and disability. [2] diagnoses in Tamalanrea public health center, Osteoarthritis is more common in the joints Makassar. Sample is divided into two group, the that support the body, especially the knee intervention group by giving Kaempferia joint. OA knee contribute greatly to the galanga L. 160 mg/day and control group by burden of physically handicapped. [3] giving meloxicam 15mg/day for 10 days. The incidence of OA increases with Outcomes measures using Western Ontario and age and is estimated about 80% of the McMaster Universities Osteoarthritis Index population age 65 has some radiographic (WOMAC) with a visual analog scale (0-10cm) [4] for pain, stiffness, and physical function. evidence of OA disease. In the United Result: The study found out, from 40 samples, States, estimated to affect more than 27 5 were dropped out and 35 samples completed million people and cause disability and the study (18 intervention and 17 control group). impaired quality of life of elderly. [5] In Both groups at the baseline did not show any Asia, OA become the most common disease differences. At the end of the study, there was a associated with various risk factors such as significant reduction both intervention and age, obesity and jobs. Cross-sectional study control group for the three WOMAC indicators conducted in India the prevalence of OA (pain, stiffness and physical function) with p according to the criteria ACR and EULAR <0.05 and their reduction did not differ 2009, respectively 17% and 5.6% in adults significantly for both groups. (<60 years) and 54.1% and 16.4% in the Conclusion: Kaempferia galanga L. extract has [6] the same effectiveness as meloxicam for the elderly (> 60 years). The prevalence of treatment of knee Osteoarthitis. Therefore, knee OA in Thailand reported there were Kaempferia galanga L. as herbal medicine can 31% male and 35% female while in China, be used for treatment for Osteoarthritis. the prevalence of knee OA 4% in men and 10% in women aged over 40 years. [7] Meta- International Journal of Science and Healthcare Research (www.gkpublication.in) 37 Vol.2; Issue: 4; October-December 2017 Akmal Novrian Syahruddin et al. The Effects of Kaempferia Galanga L. Extract on Pain, Stiffness and Functional Physic in Patient with Knee Osteoarthritis: Double Blind Randomized Clinical Trial analysis of Prevalence of knee OA between some inflammatory mediators present in women and men showed that the incidence joints. [16] of OA in men <55 years was lower than for The findings show that the women. While women aged ≥55 years had Kaempferia galanga l. extract can be used as more severe knee OA. This indicates that an alternative medicinal plant for the the incidence of knee OA of the difference reduction of symptoms and clinical signs of between the sexes occurs after the age of inflammation in OA patients such as pain, menopause. In Korea, the prevalence of swelling, joint stiffness and disability in knee OA men reach 38.1%, [8] in Vietnam addition to pharmaceutical drugs such as prevalence of radiographic knee OA was Meloxicam. The purpose of this research is 34.2%, with women having a higher rate to know the effect of Kaempferia galanga l than men (35.3% vs 31.2%). [9] extract. Against symptoms and clinical signs OA treatment management focuses of inflammation in the form of pain, joint on controlling pain and improving function stiffness and impaired physical function of and quality of life. Use of non-steroidal anti- knee OA patients. inflammatory drugs (NSAIDs) is effective to overcome the chronic pain in the knee MATERIALS AND METHODS one Meloxicam which has the function of Location and Research Design analgesic, anti-inflammatory and This study was Double Blind antipyretic. However, if its use in the long Randomized Clinical Trial, (RCT) and aim term will lead to gastrointestinal side to see the effect of Kaempferia galanga L. effects. extract compared with the control group of The use of phytropharmaca meloxicam in knee OA patients. The study (medicinal plants) for treatment has long was conducted after obtaining approval been practiced and tends to increase. One of from the research ethics committee of the the plants used for traditional medicine is Medical Faculty of Universtitas Kaempferia galanga l. Kencur (Kaempferia Hasanuddin. All procedures undertaken in galanga L.) is also included in the this study are in accordance with the Zingeberaceae family is an herbal medicine standards of the ethics committee. plant original from Indonesia. [10] This finding is reinforced that Kaempferia Method of Collecting Data galanga L. contains essential oils that can Sample Selection and provide analgesic and anti-inflammatory Implementation this research was conducted effects, especially in arthritis disease. [11] in the working area of Tamalanrea Health The main content of essential oil Center, Makassar City. The inclusion from Kaempferia galanga L. is Ethyl p- criteria in the study were subjects with methoxycinnamate (EPMC), and is the most Knee-Lawrence (KL) [17] age 40-80 years of important constituent responsible for most age, both in men and women, who had not pharmacology of the Kaempferia galanga L. undergone analgesic and anti-inflammatory plant. including anti-inflammatory and treatment at least seven days, willing to analgesic. [12,13] In addition, it was reported participate in the research by signing that Kaempferia galanga L. was informed consent. The exclusion criteria is hepatoprotective. [14] to have no history of liver and kidney Several studies have shown that disease and not allergic to Kaempferia alcohol extract K. galangal l has analgesic galanga l. and meloxicam. activity as a painkiller such as pain. [15] In The extract from Kaempferia vitro studies also show the content of ethyl galanga L. used in this study is a product p-methoxycinnamate in Kaempferia galanga developed by the Center for the L. has antiinflammatory activity capable of Development and Application of Traditional inhibiting COX-1 and COX-2 as well as Medicine (SP3T), South Sulawesi Province, International Journal of Science and Healthcare Research (www.gkpublication.in) 38 Vol.2; Issue: 4; October-December 2017 Akmal Novrian Syahruddin et al. The Effects of Kaempferia Galanga L. Extract on Pain, Stiffness and Functional Physic in Patient with Knee Osteoarthritis: Double Blind Randomized Clinical Trial under the auspices of the Ministry of Health (n=20) were given meloxicam 15 mg / day of the Republic of Indonesia. A total of 40 and administered for 10 days, total of 20 knee OA samples are collected and have samples were included in the intervention met the criteria and and divided into two group and 20 samples into the control groups: the intervention group (n=20) who group. Kaempferia galanga L. extract received Kaempferia galanga L extract capsules and meloxicam are made with the capsules 160mg / day and the control group same sighting. Sample eligibility (n = 40) Randomization Intervention Group Allocation Control Group Kaempferia galanga l.Extract Meloxicam 160 mg/day 15 mg/day (n = 20) Pre-Test (n =20) Pain, Stiffness, Functional, WOMAC Total 10 Days 10 Days Drop Out (Day- 5) Drop Out (Day- 5) Participant withdrew 1 Participant withdrew 1 Discontinued intervention 1 Discontinued intervention 2 Kaempferia galanga l.Extract Meloxicam (Day- 10) (Day- 10) 160 mg/day 15 mg/day (n = 18) (n =17) Post-Test Pain, Stiffness, Functional, WOMAC Total Analysis Figure1. Participant flow chart from 0-10. The highest score ("10") Data Analysis represent poor or very painful functions; Measurement outcomes were while the lowest score ("0") represents no assessed based on the Western Ontario and pain or normal. [9] The data have been McMaster Universities Osteoarthritis index collected and then put into Microsoft excel, (WOMAC) scores on day 0 and day 10, were analyzed using SPSS version 21. respectively. WOMAC Index consists of Independent t-test and paired t-test was used three subscales: pain, stiffness, physical to compare the mean scores between groups function. The assessment of each scale and changes in scores before and after using visual analog scale (VAS) is a intervention horizontal line along the 10 cm with a range RESULTS Characteristics of Sample International Journal of Science and Healthcare Research (www.gkpublication.in) 39 Vol.2; Issue: 4; October-December 2017 Akmal Novrian Syahruddin et al. The Effects of Kaempferia Galanga L.