Efficacy and safety of Ojeok-san in Korean female patients with cold hypersensitivity in the hands and feet: study protocol for a randomized, double-blinded, placebo-controlled, multicenter pilot study

Youme Ko, Ho-Yeon Go, In-Sik Han, Kyou-Young Lee, Tae-Hoon Kim, Jin-Moo Lee, Jun-Bok Jang, Yun-Kyung Song, Seung-Ho Sun, Chan-Yong Jeon, Seong-Gyu Ko, Youme Ko, Ho-Yeon Go, In-Sik Han, Kyou-Young Lee, Tae-Hoon Kim, Jin-Moo Lee, Jun-Bok Jang, Yun-Kyung Song, Seung-Ho Sun, Chan-Yong Jeon, Seong-Gyu Ko

Abstract

Background: This study aims to evaluate the safety, efficacy, and feasibility of a full randomized clinical trial of Ojeok-san in Korean female patients with cold hypersensitivity in the hands and feet.

Methods: This study is a multicenter, double-blinded, randomized, placebo-controlled, two-arm, parallel-group pilot clinical trial. A total of 60 participants will be enrolled and randomly assigned to the Ojeok-san treatment group or the placebo control group, in a 1:1 ratio using an Internet-based randomization system. Each group will be administered Ojeok-san or placebo three times per day for 8 weeks. The primary outcome will be the mean change in the Visual Analog Scale scores of cold hypersensitivity in the hands from baseline to week 8. Secondary outcomes will include the mean changes in the skin temperature of the extremities, recovery rate of the skin temperature of hands after cold stress test, and the score of Korean version of the WHO Quality of Life Scale abbreviated version.

Discussion: The findings of this study should provide meaningful information for a further large-scale, randomized controlled trial to confirm the safety and efficacy of Ojeok-san on cold hypersensitivity in the hands and feet in female patients.

Trial registration: ClinicalTrials.gov, ID: NCT03083522 . Registered on 20 March 2017.

Keywords: Cold hypersensitivity; Cold temperature; Herbal medicine; Korean medicine; Randomized clinical trial.

Conflict of interest statement

Ethics approval and consent to participate

The Institutional Review Boards (IRB) of Kyung Hee University Oriental Medical Center (KOMCIRB-170120-HR-001-08), Kyung Hee University Oriental Medicine Hospital at Gangdong (KHNMCOH 2017–02–002-001), Semyung University second affiliated Oriental Medical Hospital at Chungju (1702–03) have all approved the study. The study will be conducted in accordance the amended Declaration of Helsinki and the regulations of the “Good Clinical Practice” principles in the KFDA. We will provide enough explanation and time for participants to decide whether to participate in the clinical study, and written informed consent will be obtained from all participants before beginning the clinical trial.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow chart of study procedure

References

    1. Lee D, Kim H, Yu J. A survey on Korean medicine doctors’ recognition and treatment for developing Korean medicine clinical practice guideline of coldness of hands and feet. J Korean Obstet Gynecol. 2017;30(3):92–116.
    1. Sun SH, Go HY, Ko SW, et al. A Delphi study for treatment standardization of coldness in hands and feet. J Soc Preven Korean Med. 2015;19(3):131–140.
    1. Japanese Ministry of Health, Labour and Welfare . The 9th National Livelihood Survey. 2013.
    1. Kim C, Ok S, Jung J, et al. Recognition of family practitioners on cold hands/feet syndrome and Raynaud/s disease. J Korean Acad Fam Med. 2007;28:339–345.
    1. Choi KH, Kang SW, You CH. The determinants of choosing traditional Korean medicine or conventional medicine: findings from the Korea Health Panel. Evid. Based Complement. Alternat. Med. 2015;2015:9. doi: 10.1155/2015/147408.
    1. Ratchford EV, Evans NS. Raynaud’s phenomenon. Vasc Med. 2015;20(3):269–271. doi: 10.1177/1358863X15579122.
    1. Kim C. Diagnosis and management of cold hypersensitivity in hands and feet. presented at annual meeting of Korean Society for Health Promotion and Disease Prevention. Seoul: Jin Publishing Co.; 2015.
    1. Lee SL, Lee KS, Song BK. The literature review on the cold hypersensitivity of women. Korean J Obstet Gynecol. 1996;9:55–80.
    1. Yoshino T, Katayama K, Munakata K, et al. Statistical analysis of Hie (cold sensation) and Hiesho (cold disorder) in Kampo Clinic. Evid. Based Complement. Alternat. Med. 2013, Article ID 398458:8 10.1155/2013/398458.
    1. Chen SW. Prescriptions from the Great Peace Imperial Grace Pharmacy. Liu JY revised. Beijing. People's Health Publishing House. 2007;2:10.
    1. Kang KH, Kang YS, Lee YT. Application of Ojuck-san in Hyungsang medicine. Korean J Orient Physiol Pathol. 2004;18(2):389–395.
    1. Ha H, Lee JK, Lee HY, Seo CS, Kim JH, Lee MY, Koh WS, Shin HK. Evaluation of safety of the herbal formula Ojeok-san: acute and sub-chronic toxicity studies in rats. J Ethnopharmacol. 2010;131(2):410–416. doi: 10.1016/j.jep.2010.07.011.
    1. Lee N, Ha H, Lee H, et al. Analysis of Studies on Ojeok-san for Establishment of Evidence Based Medicine. Korean j Herb Formul Sci. 2008;6(2):1–9
    1. Korea Ministry of Health & Welfare . National survey of oriental medicine utilization and herbal drug consumption. Seoul: Korea Ministry of Health & Welfare Press; 2011.
    1. Park KS, Park KI, Kim JW, et al. Efficacy and safety of Korean red ginseng for cold hypersensitivity in the hands and feet: a randomized, double-blind, placebo-controlled trial. J Ethnopharmacol. 2014;158:25–32. doi: 10.1016/j.jep.2014.09.028.
    1. Nobuhiro S, Noriyuki T, Kenichi I, et al. Effects of a combination preparation of Guizhi Fuling Wan and vitamin E on indefinite complaints such as stiffness of shoulder and cold feeling. East Med. 2003;19:23–43.
    1. Kim D, Kim Y, Lee K. Standardization of diagnosis of cold hypersensitivity of hands and feet by D.I.T.I. J Orient Gynecol. 2001;14(2):129–134.
    1. Harada N. Cold-stress tests involving finger skin temperature measurement for evaluation of vascular disorders in hand-arm vibration syndrome: review of the literature. Int Arch Occup Environ Health. 2002;75(1–2):14–19.
    1. Min SK, Kim KI, Lee CI, et al. Development of the Korean versions of WHO Quality of Life Scale and WHOQOL-BREF. Qual Life Res. 2002;11(6):593–600. doi: 10.1023/A:1016351406336.
    1. Nakamura S, Ichisato SM, Horiuchi S, et al. Pregnant women’s awareness of sensitivity to cold (hiesho) and body temperature observational study: a comparison of Japanese and Brazilian women. BMC Res Notes. 2011;4:278. doi: 10.1186/1756-0500-4-278.
    1. Yun J, Yun Y. A prescriptional study of Ojeoksan on clinical application. Herb Formula Sci. 2012;20(2):153–164.
    1. Ko Y, Go HY, Cho YY, et al. The efficacy and safety of Danggui-Sayuk-Ga-Osuyu-Saenggang-tang on Korean patients with cold hypersensitivity in the hands: study protocol for a pilot, double-blind, randomized, placebo-controlled, parallel-group clinical trial. Trials. 2017;8:268. doi: 10.1186/s13063-017-2002-8.
    1. Takeda Y. Understanding the life stages of women to enhance your practice. JMAJ. 2010;53(5):273–278.

Source: PubMed

Спонсоры и соавторы

Заболевания

Медикаментозные вмешательства

Подписаться