Uji Klinik Keamanan Ramuan Jamu Penurun Kolesterol

  • Zuraida Zulkarnain Balai Besar Penelitian dan Pengembangan Tanaman Obat dan Obat Tradisional Tawangmangu, Karanganyar, Indonesia
  • Agus Triyono Balai Besar Penelitian dan Pengembangan Tanaman Obat dan Obat Tradisional Tawangmangu, Karanganyar, Indonesia
  • Danang Ardiyanto Balai Besar Penelitian dan Pengembangan Tanaman Obat dan Obat Tradisional Tawangmangu, Karanganyar, Indonesia
  • Saryanto Saryanto Balai Besar Penelitian dan Pengembangan Tanaman Obat dan Obat Tradisional Tawangmangu, Karanganyar, Indonesia
Keywords: Jamu, Hypercholesterolemia, Safety

Abstract

Research on the safety of Jamu (herbal medicine) formula is important to guarantee its use in community. The Jamu Saintification development program has been resulted a cholesterol-lowering herb containing of 7 plants. This study aimed to determine the safety of the cholesterol-lowering herb. This study is a phase one of clinical trial with a pre-post group design, a single arm, involving 50 subjects with mild hypercholesterolemia without any complications and comorbidities. The intervention was conducted for 28 days at the Hortus Medicus Herbal Medicine Research House (RRJ) in 2014. Outcome parameters included clinical signs and symptoms, liver function laboratory tests (SGOT, SGPT), renal function (ureum, creatinine) and routine blood counts (hemoglobin, leukocyte, platelets, hematocrit). Subjects were requested to boil the herb everyday and drank it twice a day. The data were analyzed descriptively and statistically using SPSS. The results showed increasing in bowel frequencies of 92% subjects and abdominal pain in bowel movements of 34% subjects. These effects were still in a normal range and can be tolerated by the subjects. The paired t test analysis showed no differences in average laboratory parameters on day (D)-14 and D-28 compared to the baseline (p > 0.05). The cholesterol-lowering herbal medicine does not change the function of the liver, kidneys and blood, with mild side effects of increasing the frequencies of bowel movements and stomachaches.

References

World Health Organization. WHO global report on traditional and complementary medicine 2019. Geneva: WHO; 2019.

Parveen A, Parveen B, Parveen R, Ahmad S. Challenges and guidelines for clinical trial of herbal drugs. Journal of Pharmacy and Bioallied Sciences. 2015;7(4):329–33. doi: 10.4103/0975-7406.168035.

Mutua DN, Juma KK, Munene M, Njagi ENJ. Safety, efficacy, regulations and bioethics in herbal medicines research and practice. Journal of Clinical Research & Bioethics. 2016;7(3):1–8. doi: 10.4172/2155-9627.1000270.

Republik Indonesia. Keputusan Menteri Koordinator Bidang Pembangunan Manusia dan Kebudayaan Republik Indonesia Nomor 22 Tahun 2019 tentang Satuan Tugas Percepatan Pengembangan dan Pemanfaatan Fitofarmaka. Jakarta: Menteri Koordinator Bidang Pembangunan Manusia dan Kebudayaan Republik Indonesia; 2019.

Republik Indonesia. Peraturan Badan Pengawas Obat dan Makanan Nomor 32 Tahun 2019 tentang Persyaratan Keamanan dan Mutu Obat Tradisional. Jakarta: Badan Pengawas Obat dan Makanan; 2019.

Purwaningsih EH. Jamu, obat tradisional asli Indonesia: pasang surut pemanfaatannya di Indonesia. eJournal Kedokteran Indonesia. 2013;1(2):85–9. https://doi.org/10.23886/ejki.1.2065.85-89.

World Health Organization. Research guidelines for evaluating the safety and efficacy of herbal medicines. Manila: World Health Organization Regional Office of Western Pacific; 1993. p 18–9.

Ardiyanto D, Triyono A, Novianto F, Mana AT. Pengaruh jamu obesitas terhadap indeks massa tubuh, lingkar perut, dan lingkar lengan dibandingkan dengan orlistat dan evaluasi keamanannya. Buletin Penelitian Kesehatan. 2018;46(3):177–82. https://doi.org/10.22435/bpk.v46i3.900.

Zulkarnain Z, Triyono A, Novianto F. Jamu formula could reduce plasma cholesterol patients with mild hypercholesterolemia. Health Science Journal of Indonesia. 2018;9(2):87–92. https://doi.org/10.22435/hsji.v9i2.808.

Harun N, Fitria V, Karningsih D. Effect of ethanol extract Sonchus arvensis Linn. leaves on acute toxicity in healthy male albino rat (Rattus norvegicus). Journal of Physics: Conference Series. 2019;1179(012163):8–11. doi: 10.1088/1742-6596/1179/1/012163.

Prahastuti S, Hidayat M, Kurniadi MW, Christiany S. Potency of black soybean (Glycine max L. Merr) and jati belanda leaves (Guazuma ulmifolia Lamk) for dyslipidemia treatment in vivo. Journal of Medicine and Health. 2016;1(3):200–13. doi: 10.28932/jmh.v1i3.515.

Huang LH, Liu CY, Wang LY, Huang CJ, Hsu CH. Effects of green tea extract on overweight and obese women with high levels of low density-lipoprotein-cholesterol (LDL-C): a randomised, double-blind, and cross-over placebo-controlled clinical trial. BMC Complementary and Alternative Medicine. 2018;18(294):1–11. doi: 10.1186/s12906-018-2355-x.

Santoshkumar J, D. Mariguddi D, Manjunath S. Comparative study of hypolidemic effects of ethanolic extract of Rhizomes of Curcuma longa (turmeric) versus Pioglitazone in Alloxan induced diabetic Rats. International Journal of Pharmacology and Clinical Sciences. 2016;5(1):5–11. doi: 10.5530/ijpcs.5.1.2.

Ahmad RS, Butt MS, Sultan MT, Mushtaq Z, Ahmad S, Dewanjee S, et al. Preventive role of green tea catechins from obesity and related disorders especially hypercholesterolemia and hyperglycemia. Journal of Translational Medicine. 2015;13(79):1–9. doi: 10.1186/s12967-015-0436-x.

Danladi S, Idris M, Umar I. Review on pharmacological activities and phytochemical constituents of Phyllanthus niruri (Amarus). The Journal of Phytopharmacology. 2018;7(3):341–8. Corpus ID: 201049637.

Ramchander PJ, Middha A. Recent advances on senna as a laxative: a comprehensive review. Journal of Pharmacognosy and Phytochemistry. 2017;6(2):349–53. Corpus ID: 79860799.

Murakami A, Nesumi A, Maeda-Yamamoto M, Yamaguchi H, Yashima K, Miura M, et al. Anthocyanin-rich tea Sunrouge upregulates expressions of heat shock proteins in the gastrointestinal tract of ICR mice: a comparison with the conventional tea cultivar Yabukita. Journal of Food and Drug Analysis. 2015;23(3):407–16. https://doi.org/10.1016/j.jfda.2014.11.004.

Goldberg C. Problem-based learning & finding the evidence: Reference : Normal Lab Values [Internet]. UC San Diego. 2012. Available from: https://ucsd.libguides.com/c.php?g=90881&p=584041

NCSS. PASS Sample Size Software Chapter 414 : One-sample Z-Tests. NCSS, LLC.; 2020. Available from:https://ncss-wpengine.netdna-ssl.com/wp-content/themes/ncss/pdf/Procedures/PASS/One-Sample_Z-Tests.pdf.

Lim JU, Lee JH, Kim JS, Hwang Y Il, Kim T, Yong SL, et al. Comparison of World Health Organization and Asia-Pacific body mass index classifications in COPD patient. International Journal of Chronic Obstructive Pulmonary Disease. 2017;12:2465–75. doi: 10.2147/COPD.S141295.

Direktorat Pencegahan dan Pengendalian Penyakit Tidak Menular. Klasifikasi obesitas setelah pengukuran IMT [Internet]. Kementerian Kesehatan RI. 2018. Available from: http://p2ptm.kemkes.go.id/infographic-p2ptm/obesitas/klasifikasi-obesitas-setelah-pengukuran-imt.

Walter SA, Kjellström L, Nyhlin H, Talley NJ, Agréus L. Assessment of normal bowel habits in the general adult population: the popcol study. Scandinavian Journal of Gastroenterology. 2010;45(5):556–66. doi: 10.3109/00365520903551332.

Lombardi N, Bettiol A, Crescioli G, Maggini V, Gallo E, Sivelli F, et al. Association between anthraquinone laxatives and colorectal cancer: protocol for a systematic review and meta-analysis. Systematic Review. 2020;9(1):1–6. doi: 10.1186/s13643-020-1280-5.

Senna. LiverTox: Clinical and research information on drug-induced liver injury. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012.

Republik Indonesia. Peraturan Kepala BPOM RI Nomor 9 Tahun 2017 tentang Larangan Memproduksi dan Mengedarkan Obat Tradisional yang mengandung Cassia senna L dan Rheum officinale dengan Klaim untuk Menurunkan Lemak Tubuh atau Menurunkan Berat Badan. Jakarta: Badan Pengawas Obat dan Makanan RI; 2017.

Gitawati R, Widowati L, Suharyanto F. Penggunaan jamu pada pasien hiperlipidemia berdasarkan data rekam medik, di beberapa fasilitas pelayanan kesehatan di Indonesia. Jurnal Kefarmasian Indonesia. 2015;5(1):41–8. doi: 10.22435/jki.v5i1.4090.41-48.

Nisa U, Saryanto, Wahyono S, Wijayanti E. Ramuan jamu saintifik hiperkolesterolemia. In : Pramono S, et al, editor. Jamu saintifik: suatu lompatan ilmiah pengembangan jamu. Tawangmangu: B2P2TOOT; 2017. p. 84-86.

Published
2021-02-23
How to Cite
1.
Zulkarnain Z, Triyono A, Ardiyanto D, Saryanto S. Uji Klinik Keamanan Ramuan Jamu Penurun Kolesterol. jki [Internet]. 23Feb.2021 [cited 29Mar.2024];11(1):8-6. Available from: http://ejournal2.litbang.kemkes.go.id/index.php/jki/article/view/3186