The Clinical Research on Ginger (Zingiber officinale): Insights from ClinicalTrials.gov analysis

Abstract

Ginger (Zingiber officinale) has a rich history of traditional medicinal use and has attracted a global interest in its health benefits. This study aims to provide insights into the clinical research landscape on ginger, focusing on its pharmacological effects and studied health-related outcomes. The study design involves systematic analysis of data from clinical trials available on ClinicalTrials.gov and discussion of findings in the context of the existing scientific knowledge. A comprehensive analysis of clinical trials registered on ClinicalTrials.gov related to ginger was first conducted, and the scientific background related to specific ginger clinical research avenues was further evaluated through PubMed searches. A variety of trial designs were identified, including treatment, prevention, and supportive care objectives. A total of 188 studies were identified on ClinicalTrials.gov, of which 89 met the inclusion criteria. Among the 89 trials, treatment objectives were predominant (47.2%), and dietary supplements (40.4%) and drugs (27%) were the most prevalent intervention types. These trials covered various health outcomes, such as antiemetic activity, analgesic function, effects on health-related quality of life, blood pressure variation, energy expenditure, and reduction in xerostomia. This study analysis provides a comprehensive overview of the clinical trials landscape on ginger, focusing on its broad spectrum of potential health benefits. While individual trials show promising results, a significant gap in the available data with a low reporting rate of final results is identified, underscoring the need for further research to establish conclusive evidence of gingerʼs therapeutic potentials.

Keywords

Zingiber officinale - ClinicalTrials.gov - antiemetic - clinical trials - pharmacological effects - therapeutic potential - interventional studies - Zingiberaceae

Publication History

Received: 23 March 2024

Accepted after revision: 28 June 2024

Accepted Manuscript online:
29 June 2024

Article published online:
19 July 2024

• References

• 1 Ali BH, Blunden G, Tanira MO, Nemmar A. Some phytochemical, pharmacological and toxicological properties of ginger (Zingiber officinale Roscoe): A review of recent research. Food Chem Toxicol 2008; 46: 409-420
• 2 Crichton M, Marshall S, Marx W, Isenring E, Lohning A. Therapeutic health effects of ginger (Zingiber officinale): Updated narrative review exploring the mechanisms of action. Nutr Rev 2023; 81: 1213-1224
• 3 Haniadka R, Saldanha E, Sunita V, Palatty PL, Fayad R, Baliga MS. A review of the gastroprotective effects of ginger (Zingiber officinale Roscoe). Food Funct 2013; 4: 845
• 4 Kress WJ, Prince LM, Williams KJ. The phylogeny and a new classification of the gingers (Zingiberaceae): Evidence from molecular data. Am J Bot 2002; 89: 1682-1696
• 5 Grzanna R, Lindmark L, Frondoza CG. Ginger–An herbal medicinal product with broad anti-inflammatory actions. J Med Food 2005; 8: 125-132
• 6 Mao QQ, Xu XY, Cao SY, Gan RY, Corke H, Beta T, Li HB. Bioactive compounds and bioactivities of ginger (Zingiber officinale Roscoe). Foods 2019; 8: 185
• 7 Prasad S, Tyagi AK. Ginger and its constituents: Role in prevention and treatment of gastrointestinal cancer. Gastroenterol Res Pract 2015; 2015: 1-11
• 8 European Medicines Agency (EMA). Zingiberis rhizoma – herbal medicinal product. Accessed May 20, 2024 at: https://www.ema.europa.eu/en/medicines/herbal/zingiberis-rhizoma
• 9 World Health Organization. WHO Monographs on Selected Medicinal Plants, Volume 1. Geneva: World Health Organization; 1999: 277-287
• 10 Ernst E. ESCOP monographs: The scientific foundation for herbal medicinal products (2nd edn). Focus Altern Complement Ther 2010; 15: 71-72
• 11 Nathan M, Robert S. The complete German commission E monographs: Therapeutic guide to herbal medicines. Ann Intern Med 1999; 130: 459
• 12 China The Pharmacopoeia Commission of PRC. Pharmacopoeia of the Peopleʼs Republic of China (English Edition 1992). Beijing: Guangdong Science and Technology Press; 1992: 215-216
• 13 Karnick CR. Pharmacopoeial Standards of Herbal Plants, Vol. 1. Delhi: Sri Satguru Publications; 1994: 347-348
• 14 European Pharmacopoeia (Ph. Eur.), 11th Edition. Strasbourg: Council of Europe; 2022
• 15 U.S. Food and Drug Administration (FDA). Food Additive Status List. Accessed May 23, 2024 at: https://www.fda.gov/food/food-additives-petitions/food-additive-status-list
• 16 Altman RD, Marcussen KC. Effects of a ginger extract on knee pain in patients with osteoarthritis. Arthritis Rheum 2001; 44: 2531-2538
• 17 Sang S, Hong J, Wu H, Liu J, Yang CS, Pan MH, Badmaev V, Ho CT. Increased growth inhibitory effects on human cancer cells and anti-inflammatory potency of shogaols from Zingiber officinale relative to gingerols. J Agric Food Chem 2009; 57: 10645-10650
• 18 Ma RH, Ni ZJ, Zhu YY, Thakur K, Zhang F, Zhang YY, Hu F, Zhang JG, Wei ZJ. A recent update on the multifaceted health benefits associated with ginger and its bioactive components. Food Funct 2021; 12: 519-542
• 19 Mao QQ, Xu XY, Cao SY, Gan RY, Corke H, Beta T, Li HB. Bioactive compounds and bioactivities of ginger (Zingiber officinale Roscoe). Foods 2019; 8: 185
• 20 Masuda Y, Kikuzaki H, Hisamoto M, Nakatani N. Antioxidant properties of gingerol related compounds from ginger. Biofactors 2004; 21: 293-296
• 21 Anh NH, Kim SJ, Long NP, Min JE, Yoon YC, Lee EG, Kim M, Kim TJ, Yang YY, Son EY, Yoon SJ, Diem NC, Kim HM, Kwon SW. Ginger on human health: A comprehensive systematic review of 109 randomized controlled trials. Nutrients 2020; 12: 157
• 22 Chen CX, Barrett B, Kwekkeboom KL. Efficacy of oral ginger (Zingiber officinale) for dysmenorrhea: A systematic review and meta-analysis. Evid Based Complement Alternat Med 2016; 2016: 1-10
• 23 Zhu J, Chen H, Song Z, Wang X, Sun Z. Effects of ginger (Zingiber officinale Roscoe) on type 2 diabetes mellitus and components of the metabolic syndrome: a systematic review and meta-analysis of randomized controlled trials. Evid Based Complement Alternat Med 2018; 2018: 1-11
• 24 Shahrajabian MH, Sun W, Cheng Q. Clinical aspects and health benefits of ginger (Zingiber officinale) in both traditional Chinese medicine and modern industry. Acta Agric Scand B Soil Plant Sci 2019; 69: 546-556
• 25 Koo KL, Ammit AJ, Tran VH, Duke CC, Roufogalis BD. Gingerols and related analogues inhibit arachidonic acid-induced human platelet serotonin release and aggregation. Thromb Res 2001; 103: 387-397
• 26 Algethami JS, El-Wahed AAA, Elashal MH, Ahmed HR, Elshafiey EH, Omar EM, Naggar YA, Algethami AF, Shou Q, Alsharif SM, Xu B, Shehata AA, Guo Z, Khalifa SAM, Wang K, El-Seedi HR. Bee pollen: Clinical trials and patent applications. Nutrients 2022; 14: 2858
• 27 Inrig JK, Califf RM, Tasneem A, Vegunta RK, Molina C, Stanifer JW, Chiswell K, Patel UD. The landscape of clinical trials in nephrology: A systematic review of clinical trials.gov. Am J Kidney Dis 2014; 63: 771-780
• 28 Saldanha LG, Dwyer JT, Betz JM. Culinary spice plants in dietary supplement products and tested in clinical trials. Adv Nutr 2016; 7: 343-348
• 29 Osterman MJK, Hamilton BE, Martin JA, Driscoll AK, Valenzuela CP. Births in the United States, 2022. Atlanta, NCHS Data Briefs. National Center for Health Statistics (U.S.); 2023
• 30 Kovac AL. Prevention and treatment of postoperative nausea and vomiting. Drugs 2000; 59: 213-243
• 31 Kalava A, Darji SJ, Kalstein A, Yarmush JM, SchianodiCola J, Weinberg J. Efficacy of ginger on intraoperative and postoperative nausea and vomiting in elective cesarean section patients. Eur J Obstet Gynecol Reprod Biol 2013; 169: 184-188
• 32 Tóth B, Lantos T, Hegyi P, Viola R, Vasas A, Benkő R, Gyöngyi Z, Vincze A, Csécsei P, Mikó A, Hegyi D, Szentesi A, Matuz M, Csupor D. Ginger (Zingiber officinale): An alternative for the prevention of postoperative nausea and vomiting. A meta-analysis. Phytomedicine 2018; 50: 8-18
• 33 Zhu W, Dai Y, Huang M, Li J. Efficacy of ginger in preventing postoperative nausea and vomiting: A systematic review and meta‐analysis. J Nurs Scholarsh 2021; 53: 671-679
• 34 Zhao C, Chen W, Wang D, Cong X, Zhu M, Zhu C, Xu J, Cai J. Ginger (Zingiber officinale Roscoe) preparations for prophylaxis of postoperative nausea and vomiting: A Bayesian network meta-analysis. J Ethnopharmacol 2023; 317: 116791
• 35 Pillai AK, Sharma KK, Gupta YK, Bakhshi S. Anti‐emetic effect of ginger powder versus placebo as an add‐on therapy in children and young adults receiving high emetogenic chemotherapy. Pediatr Blood Cancer 2011; 56: 234-238
• 36 Crichton M, Marshall S, Marx W, McCarthy AL, Isenring E. Efficacy of ginger (Zingiber officinale) in ameliorating chemotherapy-induced nausea and vomiting and chemotherapy-related outcomes: A systematic review update and meta-analysis. J Acad Nutr Diet 2019; 119: 2055-2068
• 37 Chang WP, Peng YX. Does the oral administration of ginger reduce chemotherapy-induced nausea and vomiting?. Cancer Nurs 2019; 42: E14-E23
• 38 Choi J, Lee J, Kim K, Choi HK, Lee SA, Lee HJ. Effects of ginger intake on chemotherapy-induced nausea and vomiting: A systematic review of randomized clinical trials. Nutrients 2022; 14: 4982
• 39 Kim SD, Kwag EB, Yang MX, Yoo HS. Efficacy and safety of ginger on the side effects of chemotherapy in breast cancer patients: Systematic review and meta-analysis. Int J Mol Sci 2022; 23: 11267
• 40 Sridharan K, Sivaramakrishnan G. Interventions for treating nausea and vomiting in pregnancy: A network meta-analysis and trial sequential analysis of randomized clinical trials. Expert Rev Clin Pharmacol 2018; 11: 1143-1150
• 41 Hu Y, Amoah AN, Zhang H, Fu R, Qiu Y, Cao Y, Sun Y, Chen H, Liu Y, Lyu Q. Effect of ginger in the treatment of nausea and vomiting compared with vitamin B6 and placebo during pregnancy: A meta-analysis. J Matern Fetal Neonatal Med 2022; 35: 187-196
• 42 Tan MY, Shu SH, Liu RL, Zhao Q. The efficacy and safety of complementary and alternative medicine in the treatment of nausea and vomiting during pregnancy: A systematic review and meta-analysis. Front Public Health 2023; 11: 1-17
• 43 Lakhan SE, Ford CT, Tepper D. Zingiberaceae extracts for pain: A systematic review and meta-analysis. Nutr J 2015; 14: 50
• 44 Long Z, Xiang W, He Q, Xiao W, Wei H, Li H, Guo H, Chen Y, Yuan M, Yuan X, Zeng L, Yang K, Deng Y, Huang Z. Efficacy and safety of dietary polyphenols in rheumatoid arthritis: A systematic review and meta-analysis of 47 randomized controlled trials. Front Immunol 2023; 14: 1-34
• 45 Mathieu S, Soubrier M, Peirs C, Monfoulet LM, Boirie Y, Tournadre A. A meta-analysis of the impact of nutritional supplementation on osteoarthritis symptoms. Nutrients 2022; 14: 1607
• 46 Daily JW, Zhang X, Kim DS, Park S. Efficacy of ginger for alleviating the symptoms of primary dysmenorrhea: A systematic review and meta-analysis of randomized clinical trials. Pain Med 2015; 16: 2243-2255
• 47 Martins LB, Rodrigues AMS, Rodrigues DF, Santos LCD, Teixeira AL, Ferreira AVM. Double-blind placebo-controlled randomized clinical trial of ginger (Zingiber officinale Rosc.) addition in migraine acute treatment. Cephalalgia 2019; 39: 68-76
• 48 Del Grossi Moura M, Lopes LC, Biavatti MW, Kennedy SA, de Oliveira E Silva MC, Silva MT, de Cássia Bergamaschi C. Oral herbal medicines marketed in Brazil for the treatment of osteoarthritis: A systematic review and meta‐analysis. Phytother Res 2017; 31: 1676-1685
• 49 Rivera JO, Hughes HW, Stuart AG. Herbals and asthma: Usage patterns among a border population. Ann Pharmacother 2004; 38: 220-225
• 50 Townsend EA, Siviski ME, Zhang Y, Xu C, Hoonjan B, Emala CW. Effects of ginger and its constituents on airway smooth muscle relaxation and calcium regulation. Am J Respir Cell Mol Biol 2013; 48: 157-163
• 51 Jiang Y, Turgeon DK, Wright BD, Sidahmed E, Ruffin MT, Brenner DE, Sen A, Zick SM. Effect of ginger root on cyclooxygenase-1 and 15-hydroxyprostaglandin dehydrogenase expression in colonic mucosa of humans at normal and increased risk for colorectal cancer. Eur J Cancer Prev 2013; 22: 455-460
• 52 Nikkhah-Bodaghi M, Maleki I, Agah S, Hekmatdoost A. Zingiber officinale and oxidative stress in patients with ulcerative colitis: A randomized, placebo-controlled, clinical trial. Complement Ther Med 2019; 43: 1-6
• 53 Crichton M, Marshall S, Marx W, Isenring E, Vázquez-Campos X, Dawson SL, Lohning A. Effect of ginger root powder on gastrointestinal bacteria composition, gastrointestinal symptoms, mental health, fatigue, and quality of life: a double-blind placebo-controlled trial. J Nutr 2023; 153: 3193-3206
• 54 Babaahmadi-Rezaei H, Kheirollah A, Hesam S, Ayashi S, Aberumand M, Adel MH, Zamanpour M, Alasvand M, Amozgari Z, Noor-Behbahani M, Niknam Z. Decreased lipoprotein (a) and serum high-sensitivity C-reactive protein levels in male patients with atherosclerosis after supplementation with ginger: A randomized controlled trial. ARYA Atheroscler 2020; 16: 153-160
• 55 Ebrahimzadeh A, Ebrahimzadeh A, Mirghazanfari SM, Hazrati E, Hadi S, Milajerdi A. The effect of ginger supplementation on metabolic profiles in patients with type 2 diabetes mellitus: A systematic review and meta-analysis of randomized controlled trials. Complement Ther Med 2022; 65: 102802
• 56 Hasani H, Arab A, Hadi A, Pourmasoumi M, Ghavami A, Miraghajani M. Does ginger supplementation lower blood pressure? A systematic review and meta‐analysis of clinical trials. Phytother Res 2019; 33: 1639-1647
• 57 Mansour MS, Ni YM, Roberts AL, Kelleman M, Roychoudhury A, St-Onge MP. Ginger consumption enhances the thermic effect of food and promotes feelings of satiety without affecting metabolic and hormonal parameters in overweight men: A pilot study. Metabolism 2012; 61: 1347-1352
• 58 Wang J, Li D, Wang P, Hu X, Chen F. Ginger prevents obesity through regulation of energy metabolism and activation of browning in high-fat diet-induced obese mice. J Nutr Biochem 2019; 70: 105-115
• 59 Gregersen NT, Belza A, Jensen MG, Ritz C, Bitz C, Hels O, Frandsen E, Mela DJ, Astrup A. Acute effects of mustard, horseradish, black pepper and ginger on energy expenditure, appetite, ad libitum energy intake and energy balance in human subjects. Br J Nutr 2013; 109: 556-563
• 60 Fagundes GBP, Rodrigues AMS, Martins LB, Monteze NM, Correia MITD, Teixeira AL, Ferreira AVM. Acute effects of dry extract of ginger on energy expenditure in eutrophic women: A randomized clinical trial. Clin Nutr ESPEN 2021; 41: 168-174
• 61 Hopcraft M, Tan C. Xerostomia: an update for clinicians. Aust Dent J 2010; 55: 238-244
• 62 Iorgulescu G. Saliva between normal and pathological. Important factors in determining systemic and oral health. J Med Life 2009; 2: 303-307
• 63 Zick SM, Turgeon DK, Ren J, Ruffin MT, Wright BD, Sen A, Djuric Z, Brenner DE. Pilot clinical study of the effects of ginger root extract on eicosanoids in colonic mucosa of subjects at increased risk for colorectal cancer. Mol Carcinog 2015; 54: 908-915
• 64 Jiang Y, Turgeon DK, Wright BD, Sidahmed E, Ruffin MT, Brenner DE, Sen A, Zick SM. Effect of ginger root on cyclooxygenase-1 and 15-hydroxyprostaglandin dehydrogenase expression in colonic mucosa of humans at normal and increased risk for colorectal cancer. Eur J Cancer Prev 2013; 22: 455-460
• 65 Mozaffari-Khosravi H, Naderi Z, Dehghan A, Nadjarzadeh A, Huseini HF. Effect of ginger supplementation on proinflammatory cytokines in older patients with osteoarthritis: Outcomes of a randomized controlled clinical trial. J Nutr Gerontol Geriatr 2016; 35: 209-218
• 66 Naderi Z, Mozaffari-Khosravi H, Dehghan A, Nadjarzadeh A, Huseini HF. Effect of ginger powder supplementation on nitric oxide and C-reactive protein in elderly knee osteoarthritis patients: A 12-week double-blind randomized placebo-controlled clinical trial. J Tradit Complement Med 2016; 6: 199-203
• 67 Dilokthornsakul W, Rinta A, Dhippayom T, Dilokthornsakul P. Efficacy and safety of ginger regarding human milk volume and related clinical outcomes: A systematic review of randomized controlled trials. Complement Med Res 2022; 29: 67-73
• 68 Paritakul P, Ruangrongmorakot K, Laosooksathit W, Suksamarnwong M, Puapornpong P. The effect of ginger on breast milk volume in the early postpartum period: A randomized, double-blind controlled trial. Breastfeed Med 2016; 11: 361-365