• ULFATUN NISA Division of Clinical Study, Medicinal Plant and Traditional Medicine Research and Development Centre, National Institute Health and Research Development, Indonesia.
  • PERISTIWAN R WIDHI ASTANA Division of Clinical Study, Medicinal Plant and Traditional Medicine Research and Development Centre, National Institute Health and Research Development, Indonesia.


Objective: The objective of the study was to evaluate the safety and efficacy of antiurolithic herbal formula (AHF) compared with commercial polyherbal lithotriptic (CPL) agent in urolithiasis subjects.

Materials and Method: The study was conducted with the design of purposive randomized open-label, end-blinded observation. The sample size and randomization were done by computer with generated statistical program. The total of subjects who met the inclusion and exclusion criteria was 200 patients. Every subject was given AHF or CPL according to their group and the intervention was carried out for 8 weeks. The study used the difference of stone’s size and number as parameter to observe the efficacy between two groups. While in terms of safety, this study used biochemical parameters of liver and kidney function.

Results: A total of 191 adult patients with urolithiasis were enrolled. There were 97 and 94 subjects in AHF and CPL group, respectively. The study showed a significant size reduction of single’s and multiple’s stone in AHF group (p<0.05). The size reduction difference in AHF group is greater than in CPL group. The number of multiple stone’s subjects who treated AHF was significantly decreased. Whereas in CPL group, there was no significant size difference between pre and prost treatment. The biochemical parameters showed normal liver and renal function in both groups.

Conclusion: This study result indicates that AHF is safe and effective in the treatment of urolithiasis.

Keywords: antiurolithic, herbal, formula, clinical study


1. Sharma G, Lamichhane G. A review of plant based medicine in treatment of urolithiatic disorder. Pharm Innov J 2017;6:8-12.
2. Anbu J, Suman S, Swaroop KS, Kumar SL, Satheesh SK, Kannadhasan R. Antiurolithiatic activity of ethyl acetate root extract of Ichnocarpusfrutescens using ethylene glycol induced method in rats. J Pharm Sci Res. 2011;3:1182-9.
3. Poojar B, Ommurugan B, Adiga S, Thomas H. Evaluation of antiurolithiatic property of ethanolic extract of fennel seeds in male wistar albino rats. Asian J Pharm Clin Res 2017;10:313.
4. Peres A, Santos FM, Mandotti MR, Alberto L, Peres B. Metabolic investigation in patients with nephrolithiasis. Einstein 2017;15:452-6.
5. Aggarwal A, Singla SK, Gandhi M, Tandon C. Preventive and curative effects of Achyranthes aspera Linn. Extract in experimentally induced nephrolithiasis. Indian J Exp Biol 2012;50:201-8.
6. Gürocak S, Küpeli B. Consumption of historical and current phytotherapeutic agents for urolithiasis: A critical review. J Urol 2006;176:450-5.
7. Badan Penelitian dan Pengembangan Kesehatan. Laporan Nasional Riset Kesehatan Dasar (RISKESDAS) 2013; 2013.
8. Jain K, Sood R. Short communication evaluation of renal epithelial cell protein under stress condition. Int J Pharm Pharm Sci 2016;8:37-40.
9. Tiwari A, Soni V, Londhe V, Bhandarkar A, Bandawane D, Nipate S. An overview on potent indigenous herbs for urinary tract infirmity. Asian J Pharm Clin Res 2012;5:3-8.
10. Jarald EE, Kushwah P, Edwin S, Asghar S, Patni SA. Effect of unex on ethylene glycol-induced urolithiasis in rats. Indian J Pharmacol 2011;43:466-8.
11. Rodgers AL, Webber D, Ramsout R, Gohel MD. Herbal preparations affect the kinetic factors of calcium oxalate crystallization in synthetic urine: Implications for kidney stone therapy. Urolithiasis 2014;42:221 5.
12. Mikawlrawng K, Kumar S, Vandana. Current scenario of urolithiasisa and the use of medicinal plants as antiurolithiatic agents in Manipur (North East India): A review. Int J Herb Med 2014;2:1-12.
13. Saryanto. Laporan Urolithiasis. Balai Besar Penelitian dan Pengembangan Obat dan Obat Tradisional;2012.
14. Association of the British Pharmaceutical Industry. Guidelines for Phase 1 Clinical Trials. 2012th ed; 2012.
15. Sodimbaku V, Pujari L. Urolithiasis-an updated review over genetics, pathophysiology and its clinical management. Int J Pharm Pharm Sci 2014;6:23-31.
16. Scales CD Jr., Curtis LH, Norris RD, Springhart WP, Sur RL, Schulman KA, et al. Changing gender prevalence of stone disease. J Urol 2007;177:979-82.
17. Sakhaee K, Maalouf NM, Sinnott B. Clinical review. Kidney stones 2012: Pathogenesis, diagnosis, and management. J Clin Endocrinol Metab 2012;97:1847-60.
18. Sarica K, Altay B, Erturhan S. Effect of being overweight on stone-forming risk factors. Urology 2008;71:771-4.
19. Hamano S, Nakatsu H, Suzuki N, Tomioka S, Tanaka M, Murakami S, et al. Kidney stone disease and risk factors for coronary heart disease. Int J Urol 2005;12:859-63.
20. Astana W, Zulkarnain Z. Studi Klinis Ramuan Jamu Batu Saluran Kemih. Kesan: Pros SEMNAS Si Manis Berujung Kronis; 2013.
21. Dalimartha S. Atlas Tumbuhan Obat Indonesia. Jakarta: Niaga Swadaya; 1999.
22. Chairul SM, Sumarny R. Aktivitas antioksidan ekstrak air daun tempuyung (Sonchus arvensis L) secara in-vitro antioxidant activity of aqueous extract of sonchus. Majalah Farm Indones 2003;14:208-15.
23. Ana HH, Anggraini Y. Pengaruh frekuensi penggunaan teh daun tempuyung kering (Soncsus arvensis) terhadap daya larut. J Kesehat 2009;2:30-7.
24. Nagal A, Singla RK. Herbal resources with antiurolithiatic effects: A review. Indo Glob J Pharm Sci 2013;3:6-14.
25. Adnyana K, Setiawan F, Insanu M. From ethnopharmacology to clinical study of Orthosiphon stamineus Benth. Int J Pharm Pharm Sci 2013;5:66-73.
26. Singh MK, Gidwani B, Gupta A, Dhongade H, Kaur CD, Kashyap PP, et al. A review of the medicinal plants of genus Orthosiphon (Lamiaceae). Int J Biol Chem 2015;9:318-31.
27. Dharma S, Aria M, Syukri EF. (Strobilanthes crispa (L) Blume) terhadap kelarutan kalsium dan oksalat sebagai komponen batu ginjal pada urin. Scientia 2014;4:34-7.
28. Kumaran MG, Patki PS. Evaluation of an ayurvedic formulation (Cystone), in urolithiasis: A double blind, placebo-controlled study. Eur J Integr Med 2011;3:23-8.
29. Butterweck V, Khan SR. Herbal medicines in the management of urolithiasis: Alternative or complementary? Planta Med 2009;75:1095 103.
30. Srinivasan S, Kalaiselvi P, Sakthivel R, Pragasam V, Muthu V, Varalakshmi P, et al. Uric acid: An abettor or protector in calcium oxalate urolithiasis? Biochemical study in stone formers. Clin Chim Acta 2005;353:45-51.
31. Peng J, Jones GL, Watson K. Stress proteins as biomarkers of oxidative stress: Effects of antioxidant supplements. Free Radic Biol Med 2000;28:1598-606.
32. Green ML, Freel RW, Hatch M. Lipid peroxidation is not the underlying cause of renal injury in hyperoxaluric rats. Kidney Int 2005;68:2629 38.
33. Selvam R. Calcium oxalate stone disease: Role of lipid peroxidation and antioxidants. Urol Res 2002;30:35-47.
34. Ma J, Sun H, Liu H, Shi GN, Zang YD, Li CJ, et al. Hepatoprotective glycosides from the rhizomes of Imperata cylindrical. J Asian Nat Prod Res 2018;20(5):451-9.
35. Oon SF, Nallappan M, Tee TT, Shohaimi S, Kassim NK, Sa’ariwijaya MS, et al. Xanthorrhizol: A review of its pharmacological activities and anticancer properties. Cancer Cell Int 2015;15(1):100.
44 Views | 24 Downloads
How to Cite
ULFATUN NISA, and PERISTIWAN R WIDHI ASTANA. “EVALUATION OF ANTIUROLITHIC HERBAL FORMULA FOR UROLITHIASIS: A RANDOMIZED OPEN-LABEL CLINICAL STUDY”. Asian Journal of Pharmaceutical and Clinical Research, Vol. 12, no. 4, Feb. 2019, pp. 88-93, https://innovareacademics.in/journals/index.php/ajpcr/article/view/30232.
Original Article(s)