Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

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

Authors: 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

Published in: Trials | Issue 1/2018

Login to get access

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.
Appendix
Available only for authorised users
Literature
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.
2.
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):131–40.
3.
4.
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;28:339–45.
5.
6.
Ratchford EV, Evans NS. Raynaud’s phenomenon. Vasc Med. 2015;20(3):269–71.CrossRef
7.
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.
8.
Lee SL, Lee KS, Song BK. The literature review on the cold hypersensitivity of women. Korean J Obstet Gynecol. 1996;9:55–80.
9.
10.
Chen SW. Prescriptions from the Great Peace Imperial Grace Pharmacy. Liu JY revised. Beijing. People's Health Publishing House. 2007;2:10.
11.
Kang KH, Kang YS, Lee YT. Application of Ojuck-san in Hyungsang medicine. Korean J Orient Physiol Pathol. 2004;18(2):389–95.
12.
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):410–6.CrossRef
13.
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
14.
Korea Ministry of Health & Welfare. National survey of oriental medicine utilization and herbal drug consumption. Seoul: Korea Ministry of Health & Welfare Press; 2011.
15.
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.CrossRef
16.
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.
17.
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):129–34.
18.
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):14–9.PubMed
19.
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.CrossRef
20.
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.CrossRef
21.
Yun J, Yun Y. A prescriptional study of Ojeoksan on clinical application. Herb Formula Sci. 2012;20(2):153–64.
22.
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.CrossRef
23.
Takeda Y. Understanding the life stages of women to enhance your practice. JMAJ. 2010;53(5):273–8.
Metadata
Title
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
Authors
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
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-3013-9

Other articles of this Issue 1/2018

Trials 1/2018 Go to the issue

Study protocol

The HYSTER study: the effect of intracervically administered terlipressin versus placebo on the number of gaseous emboli and fluid intravasation during hysteroscopic surgery: study protocol for a randomized controlled clinical trial

Study protocol

Open-label, randomized multicentre phase II study to assess the efficacy and tolerability of sunitinib by dose administration regimen (dose modification or dose interruptions) in patients with advanced or metastatic renal cell carcinoma: study protocol of the SURF trial

Study protocol

Treatment of Middle East Respiratory Syndrome with a combination of lopinavir-ritonavir and interferon-β1b (MIRACLE trial): study protocol for a randomized controlled trial

Study protocol

TRACE (Routine posTsuRgical Anesthesia visit to improve patient outComE): a prospective, multicenter, stepped-wedge, cluster-randomized interventional study

Study protocol

Reduced fetal movement intervention Trial-2 (ReMIT-2): protocol for a pilot randomised controlled trial of standard care informed by the result of a placental growth factor (PlGF) blood test versus standard care alone in women presenting with reduced fetal movement at or after 36+ 0 weeks gestation

Study protocol

Comparing satisfaction with a participatory driven web-application and a standard website for patients with low back pain: a study protocol for a randomised controlled trial (part of the ADVIN Back Trial)