Browse > Article
http://dx.doi.org/10.7231/jon.2018.29.1.035

A Research to Evaluate the Safety and Efficacy of Yukwool-tang (Liuyu-tang) for Major Depression in Women: A Study Protocol for a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Trial  

Seo, Young Kyung (Clinical Trial Center, Dunsan Korean Medicine Hospital of Daejeon University)
Lee, Eun Hee (Department of Oriental Neuropsychiatry, College of Korean Medicine, Daejeon University)
Kim, Hwan (Department of Oriental Neuropsychiatry, College of Korean Medicine, Daejeon University)
Lee, Ji-yoon (Department of Oriental Neuropsychiatry, College of Korean Medicine, Daejeon University)
Park, Chae Rin (Clinical Trial Center, Dunsan Korean Medicine Hospital of Daejeon University)
Choi, Sunyoung (Division of Clinical Medicine, Korea Institute of Oriental Medicine)
Jang, Eunsu (Department of Diagnosis, College of Korean Medicine, Daejeon University)
Kwon, Ojin (Division of Clinical Medicine, Korea Institute of Oriental Medicine)
Kim, Hyungjun (Division of Clinical Medicine, Korea Institute of Oriental Medicine)
Jung, In Chul (Department of Oriental Neuropsychiatry, College of Korean Medicine, Daejeon University)
Publication Information
Journal of Oriental Neuropsychiatry / v.29, no.1, 2018 , pp. 35-46 More about this Journal
Abstract
Objectives: The aim of this trial is to evaluate the efficacy and safety of Yukwool-tang (Liuyu-tang) for the treatment of major depression in women by comparing the Yukwool-tang (Liuyu-tang)-treated group with the placebo-treated group and assessing the association of various biological factors related to depression through various outcome measures. Methods: This study is a single-center, randomized, double-blind, placebo-controlled, parallel-design clinical trial. The subjects to be selected are women between the ages of 19 and 65, and the registered subjects are to be randomly assigned to treatment with Yukwool-tang or the placebo control. The Yukwool-tang group will take 1 bottle of Yukwool-tang (30 mg) for 8 weeks, 3 times a day, before meals. The control group will take the placebo in the same way. The primary outcome to be examined will be the change between the total score after 8 weeks and the total score before the start of the study of the K-HDRS score. Secondary outcomes are assessed by the change in total score after 12 weeks of K-HDRS, K-HDRS remission rate, K-HDRS improvement rate, BDI-K, PITD, KSCL-95, ISI, STAI-K, EQ-5D, VAS, Emotional Stimulation Test, BDNF test, inflammatory cytokine and tumor necrosis factor test, intestinal microbiome test, dietary report and Beck's hopelessness scale. Results: This protocol has been approved by the IRB of Dunsan Korean Medicine Hospital of Daejeon University and is registered in the CRIS, and it is made public in advance to ensure transparency of the research process and conduct ethical clinical trials. Conclusions: Based on this protocol, when the trial is completed, its data can be used to access the validity and safety of Yukwool-tang for major depression in women, and it is also expected to be helpful in the study of the correlation between future treatment of Korean medicine for depression and related biological factors, and quality of life.
Keywords
Major depression of women; Yukwool-tang (Liuyu-tang); Study protocol; RCT;
Citations & Related Records
Times Cited By KSCI : 1  (Citation Analysis)
연도 인용수 순위
1 The Korean Society of Oriental Neuropsychiatry Textbook Compilation Committee. Oriental Neuropsychiatry (3rd ed). Gyeonggi : Jipmoondang. 2016;249-59.
2 Heo J. Donguibogam. Gyeongnam: Dongeuibogam Publishing House. 2006:1382-6.
3 Hwang UW, Kim JH. Korean Psychiatry. Seoul: Hyeondae Medical Books. 1987:608-11.
4 Mun JJ, Ahn GS, Choi SH. Oriental Pathology. Seoul : Gomunsa. 1990:60-2.
5 The Korean Neuropsychiatric Association. Textbook of neuropsychiatry 3rd ed. Seoul : iMiS Company. 2017:273-80.
6 Cheon JS. Neurobiology of Depression in Women. J. of Korean Geriatric Psychiatry. 1999;3(2):129-39.
7 Gongshin. Gogeumuigam. Jiangxi : Scientific & Technical Publishing House. 1990: 98-100.
8 Bae GC. Standard Clinical Medical Herbalprescriptions. Seoul : Traditional Medicine Institute. 1995;300-2.
9 Yang OS. Gogeummyeongbang. Hanam : Scientific & Technical Publishing House. 1983;168-9.
10 Lee SI, et al. Medical Herbalprescriptions. Seoul : Yeonglimsa. 1998;228-9.
11 Cho YD, Kim JH, Hwang UW. Effect of Yukultang on the gastric ulcer and plasma Catecholamines contents of rats in immobilization stress. Collection of dissertations of Kyung-hee College of Korean medicine. 1992;15(1):431-48.
12 Choi HS, Kim CJ, Cho CS, The Effects of YUKWOOLTANG on the Hyperthyroidism of Rats. The Korea journal of herbology. 2006;21(4):11-7.
13 Choi YH, Choi BT, Lee YT, Induction of Apoptosis by Yukwool-tang in Human Cervical Carcinoma HeLa Cells. Journal of physiology & pathology in Korean Medicine. 2007;21(6):1513-9.
14 Jung SH, Lee JM, Lee CH, Cho JH, Jang JB, Lee KS. Neuroprotective Effect of Yukul-tangagainst the Oxidative Stress. The Journal of Korean obstetrics & gynecology. 2009;22(1):15-30.
15 Ministry of Food and Drug Safety. Medicines Product Information. (https://ezdrug.mfds.go.kr/#!CCBAA03F020)
16 American Psychiatric Association. Diagnostic and statistical manual of mental disorders(4th ed). Washington, DC : American Psychiatric Association. 1994.
17 Klaus Linde, et al. St John's wort for depression - an overview and meta-analysis of randomised clinical trials. BMJ. 1996;313(7052):253-8.   DOI
18 International Conference on Harmonization of Technical Requirements for Registration of Pharmaceutical for Human Use (ICH). ICH-GCP Guideline. 2014.
19 Ministry of Food and Drug Safety. KGCP Guideine. 2000.
20 Ministry of Government Legislation. Pharmaceutical Affairs Law. 2012.
21 Ministry of Government Legislation. Bioethics and Safety Act. 2011.
22 Korean Medical Association. World Medical Association Declaration of Helsinki - Seoul revision : Ethical Principles for Medical Research Involving Human Subjects. J Korean Med Assoc. 2010;53(9):739-42.   DOI
23 Lazarus,R.S. Pattern of adjustment. NewYork : McGrew Hill. 1976:115-6.
24 Korea Institute of Oriental Medicine. Korean Medicine Clinical Practice Guideline for Depression. Seoul : Elsevier Korea L.L.C.. 2016;34-7.
25 Chang MK, Kim GW, Koo BS. Anti-depressant Effect of the Extracts of Aconitum carmichaeli. J. of Oriental Neuropsychiatry. 2009;20(3):49-64.
26 Mohoney,M.J. Abnormal psychology : Perspectives on human variance. NewYork : harper& Raw Publishers. 1980:222-5.
27 Seoul National University College of Medicine. Epidemiological survey of psychiatric illnesses in Korea. 2011.
28 Bech P, Allerup P, Gram F, Reisby N, Rosenberg R, Jacobsen O, Nagy A. The Hamilton Depression Scale. Evaluation of objectivity using logistic models. 1981;63:290-9.
29 Rehm LP, O'Hara MW. Item characteristics of the Hamilton Depression Rating Scale for Depression. J psychiat Res. 1985;19:31-41.   DOI
30 Faries D, Herrera J, Rayamajhi J, Debrota D, Demitrack M, Potter WZ. The responsiveness of the Hamilton Deoression Rating Scale. J psychiat Res. 2000;34:3-10.   DOI
31 Yi JS, Bae SO, Ahn YM, Park DB, Noh KS, Shin HK, et al. Validity and reliability of the Korean version of the Hamilton Depression Rating Scale (K-HDRS). J Korean Neuropsychiatr Assoc. 2005;44:456-65.
32 Ministry of Food and Drug Safety. HRPP Guideine. 2014.
33 Yoon SY, Lim JH, Han CS. Rating Scales for Measurement-Based Clinical Practice of Depression. Korean J Psychopharmacol. 2012;23:136-46.
34 Zimmerman M, Chelminski I, Posternak M. A review of studies of the Hamilton depression rating scale in healthy controls: implications for the definition of remission in treatment studies of depression. J Nerv Ment Dis. 2004;192:595-601.   DOI
35 Bang KM, Kim HC. Quality of Sleep and Health-Related Quality of Life in Patients with Major Mental Disorders. J Korean Soc Biol Ther psychiatry. 2005;11(2):138-49.
36 I. M. Hunt, N. Cuper, J. Robinson, J. Shaw, S.Flynn, H. Bailey, J. Meehan, H. Bickley, R. Parsons, J. Burns, T. Amos, and L. Appleby. Suicide within 12 months of mental health service contact in different age and diagnostic groups: National clinical survey. British Journal of Psychiatry. 2006;188(2):135-42.   DOI
37 Z. Rihmer. Suicide risk in mood disorders. Current Opinion in Psychiatry. 2007;20(1):17-22.   DOI
38 Park MS. A Case Study of Meditation Counseling for Reducing Anxiety Disorder of Middle-aged Men Suffering from Panic Disorder. Journal of Meditation based Psychological Counseling. 2016;15:11-20.
39 Fava GA, Grandi S, Canestrari R, Molnar G. Prodromal symptoms in primary major depressive disorder. J Affect Disorder. 1990;19:149-52.   DOI
40 Lubin B, Van Whitlock R, Zuckerman M. Affect traits in differential diagnosis of anxiety, depressive, and schizophrenic disorders using the Multiple Affect Adjective Check List-Revised. 1998;5:309-19.   DOI
41 Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQoL Group. Ann Med. 2001;33:337-43.   DOI
42 Kim SH, Ahn J, Ock M, Shin S, Park J, Luo N, et al. The EQ-5D-5L valuation study in Korea. Qual Life Res. 2016;25:1845-52.   DOI
43 Daut RL, Cleeland CS. The prevalence and severity of pain in cancer. Cancer. 1982;50:1913-18.   DOI
44 Lee HJ, Min KJ, Lee YS, Na C, Han DH. Comparison of Effect of SSRIs, SNRIs, and NaSSA on Pain. Korean J Psychopharmacol. 2012;23:176-82.
45 Kim YR, Lee KU. Understanding of Neural Mechanism of Mood Disorders : Focused on Neuroimaging Findings. Korean Journal of Biological Psychiatry. 2011;18(1):15-24.
46 Park YN. Psychiatric outpatients with physical symptoms. Keimyung Med J 1984;3:169-74.
47 Song JY, Park JC, Park JH, Oh DJ, Sohn HS, Chung KJ. Frequency and clinical characteristics of pain of the patients in psychiatric outpatient clinics. J Korean Neuropsychiatr Assoc. 1999;38:1402-11.
48 Bond MR, Pearson IB. Psychological aspects of pain in women with advanced cancer of the cervix. J Psychosom Res. 1969;13:13-9.   DOI
49 Park K. Jindanhaggwon-yeo. Daesung Publishing Company. 2000;491-2.
50 The Textbook Compliation Committee of Oriental Pathology. Oriental Pathology. Seoul: Hanimunhwasa. 2008;172,286-8,579.
51 Lee HS, Kang WC, Jung IC. Reliability and Validity Analysis of the Instrument on Pattern Identifications for Depression. J of Oriental Neuropsychiatry. 2015;26(4):407-16.   DOI
52 Mass,J.W., Fawcett,J.A., Dekirmenjian,H. 3-Methoxy-4-hydroxyphenyl-glycol(MHPG) excretion in depressive states. Arch.Gen.Psychiatry. 1968;19:129-34.   DOI
53 Goodwin, F.K., Rubovits, R.,Jimerson, D.C. 5-HT and norepinephrine "subgroups" in depression. Metabolites findings and clinical pharmacological correlation. Sci. Proc.Am.Psychiatr.Assoc. 1977;130:108-31.
54 Christopher F. Sharpleya,b, Suresh K.A. Palanisamyc, Nicarla S. Glyde d, Peter W. Dillinghamd, Linda L. Agnewa. An update on the interaction between the serotonin transporter promoter variant (5-HTTLPR), stress and depression, plus an exploration of non-confirming findings. Behavioural Brain Research. 2014;273:89-105.   DOI
55 DOWLATI, Yekta, et al. A meta-analysis of cytokines in major depression. Biological psychiatry. 2010;67(5):446-57.   DOI
56 Murer MG, Yan Q, Raisman-Vozari R. Brain-derived neurotrophic factor in the control human brain, and in Alzheimer's disease and Parkinson's disease. Prog Neurobiol. 2001;63:71-124.   DOI
57 Shimizu E, Hashimoto K, Okamura N, Koike K, Komatsu N, Kuma Kiri C, Nakazato M, Watanabe H, Shinoda N, Okada S, Iyo M. Alterations of serum levels of brain-derived neurotrophic factor (BDNF) in depressed patients with or without antidepressants. Biological Psychiatry. 2003;54:70-5.   DOI
58 Lee YM. Association Study Between Brain-Derived Neurotrophic Factor Genetic Polymorphism and Treatment Responses of Selective Serotonin Reuptake Inhibitor in Major Depressive Disorder. Journal of Korean Geriatric Psychiatry. 2008;12:34-9.
59 YOSHIMURA, Reiji, et al. Higher plasma interleukin-6 (IL-6) level is associated with SSRI-or SNRI-refractory depression. Neuro-Psychopharmacology and Biological Psychiatry. 2009;33(4):722-6.   DOI
60 FOSTER, Jane A.; NEUFELD, Karen-Anne McVey. Gut-brain axis: how the microbiome influences anxiety and depression. Trends in neurosciences. 2013;36(5):305-12.   DOI
61 PEZAWAS, L., et al. Evidence of biologic epistasis between BDNF and SLC6A4 and implications for depression. Molecular psychiatry. 2008;13(7):709.   DOI