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

Ko, Youme; Go, Ho-Yeon; Han, In-Sik; Lee, Kyou-Young; Kim, Tae-Hoon; J, Lee; Jang, Jihye; Song, Yun‐Kyung; Sun, Seung‐Ho; Jeon, Chan‐Yong; Ko, Seong‐Gyu

doi:10.1186/s13063-018-3013-9

Cited by 6 publications

(7 citation statements)

References 9 publications

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“…Several studies have been conducted to evaluate the e cacy and safety of Korean herbal medicines, including Danggui-SayukGa-Osuyu-Saenggang-tang [21], Ojeok-san [22], Sipjeondaebotang [23], Ucha-Shinki-Hwan [24], Onkyeong-tang [25], Korean Red Ginseng [26], for the treatment of CHHF. Studies of acupuncture or EA treatment for coldness have also been conducted.…”

Section: Discussionmentioning

confidence: 99%

“…First, ours is the rst RCT to assess the e cacy and safety of EA for the treatment of CHHF. There have been many RCTs to evaluate the effectiveness and safety of herbal medicines for the treatment of CHHF, but there have been no studies on the treatment of CHHF using EA or acupuncture.Second, the team members in our study had prior experience in RCTs related to CHHF, e.g., a pilot study of Danggui-SayukGa-Osuyu-Saenggang-tang [21], Ojeok-san [22], Sipjeondaebotang [23], Ucha-Shinki-Hwan [24], and Onkyeong-tang [25]; therefore, our study can be conducted more smoothly.…”

Section: Discussionmentioning

confidence: 99%

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Study Protocol for Multi-Center, Open-Label, Randomized Controlled Trial for Assessing the Efficacy and Safety of Electroacupuncture for Cold Hypersensitivity in Hands and Feet

Lee¹,

Han²,

Lee³

et al. 2021

Preprint

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Background: Cold hypersensitivity in the hands and feet (CHHF) is defined as the symptom of a sensation of coldness in the extremities under conditions that are not considered cold by an unaffected person. CHHF is common in East Asian women. CHHF can affect the quality of life by placing restrictions on one's daily activities. Although electroacupuncture (EA) and acupuncture have been widely used for treating CHHF, randomized clinical trial (RCT) has not yet been conducted for evaluating the safety and efficacy of EA or acupuncture for the treatment of CHHF. This study aims to evaluate the effects of EA in CHHF patients. Methods: This study is a randomized, multicenter, and parallel design clinical trial. Overall, 72 participants will be randomly assigned to the EA treatment group, acupuncture treatment group, and untreated control group in 1:1:1 ratio via a web-based randomization system. The EA treatment group and acupuncture treatment group will receive EA or acupuncture treatment by visiting ten times at intervals of twice a week for five weeks. Follow-up visits will be made four weeks after the end of treatment. For the untreated control group, three visits will be made. The primary outcome measures will be the CHHF visual analogue scale score. Secondary outcome measures will be the body temperature of hands and feet, total scores of the Korean version of the World Health Organization Quality of Life Scale abbreviated version, the results of the questionnaire of health-related quality of life, questionnaire of demonstration, and questionnaire of cold hypersensitivity.Discussion: This study will be the first clinical trial to evaluate the efficacy and safety of EA for the treatment of CHHF. We expect this study to provide basic evidence for the treatment of CHHF with EA, future large-scale RCT, and the development of general clinical guidelines for CHHF in the Korean medical field.Trial registration: CRIS, KCT0004306. Registered on October 14, 2019. https://cris.nih.go.kr/cris/search/search_result_st01.jsp?seq=14865

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Study Protocol for Multi-Center, Open-Label, Randomized Controlled Trial for Assessing the Efficacy and Safety of Electroacupuncture for Cold Hypersensitivity in Hands and Feet

Lee¹,

Han²,

Lee³

et al. 2021

Preprint

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“…There were many studies on the effects of OKT on gynecological diseases and coldness, but there were no RCTs to examine the safety and efficacy of OKT for CHF. This study has another strength: specifically, the team members engaged in this clinical trial are familiar with the SOPs of this study, as they were part of a previous pilot study that investigated the effects of Danggui-SayukGa-Osuyu-Saenggang-tang [20], Ojeok-san [21], or Sipjeondaebo-tang [22] on CHHF.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of Onkyeong-tang in treating cold hypersensitivity in the feet of Korean women: protocol for a double-blind, randomized, placebo-controlled, parallel-group, multicenter clinical study

Lee

Han

et al. 2020

Trials

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Background: Cold hypersensitivity in the hands and feet (CHHF) commonly affects Asian women, especially Korean women, and it negatively impacts the quality of life of the affected individuals. One commonly used herbal prescription for treating CHHF is Onkyeong-tang (OKT). Although OKT is widely used clinically in treating CHHF, no randomized clinical trial has been performed to evaluate the efficacy and safety of OKT in the treatment of cold hypersensitivity in the feet (CHF). This clinical trial aims to provide objective evidence for the basis of using OKT in the treatment of CHF in Korean women. Methods: This trial will be a double-blind, randomized, placebo-controlled, parallel-group, multicenter pilot study. A total of 112 participants will be randomly divided into an OKT treatment group or a placebo group with a 1:1 ratio via a web-based randomization system. The OKT and placebo groups will receive prescribed medications orally three times per day (3 g each time) before or between meals for 8 weeks. The primary outcome studied will be the changes in Visual Analog Scale (VAS) scores of CHF from baseline. Secondary outcomes studied will be the VAS score changes of cold hypersensitivity in the hands, changes in the skin temperature of the hands and feet, total scores of the Korean version of the World Health Organization Quality of Life Scale-abbreviated version, and the results of the cold stress test. Discussion: This trial will be the first clinical trial to assess the efficacy and safety of OKT in the treatment of CHF. We anticipate that the findings of the study will provide evidence for the basis of using OKT in treating CHF symptoms and generate basic data for designing a further large-scale randomized clinical trial.

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“…Previous studies indicated that the components of the herbal extract, including Ag, Ac, and Zo, influences various malignant tumors, such as brain, breast, prostate, colorectal, skin, and pancreatic cancer ( Choi et al, 2016 ; Li et al, 2017 ; Nedungadi et al, 2019 ), various inflammatory diseases, and obesity and has neuroprotective effects( Semwal et al, 2015 ; Zhou et al, 2015 ; Sowndhararajan and Kim, 2017 ). Furthermore, extracts from a mixture of Ag, Ac, and Zo have been shown to effective various disease effect ( Kim et al, 2016 ; Ko et al, 2018 ; Han et al, 2019 ; Cheon and Ko, 2020 ; ).…”

Section: Introductionmentioning

confidence: 99%

In vitro Anticancer Effects of JI017 on Two Prostate Cancer Cell Lines Involve Endoplasmic Reticulum Stress Mediated by Elevated Levels of Reactive Oxygen Species

Kim

Hong

et al. 2021

Front. Pharmacol.

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Prostate cancer is the second most commonly diagnosed cancer, and prostate cancer is the second most common cause of cancer death in United States men after lung cancer. Many therapies are used to treat prostate cancer, and chemotherapy is one of the most relevant treatments. However, chemotherapy has many side effects, and repeated administration of chemotherapeutic agents leads to acquired resistance. Thus, new drugs with few side effects are needed. We investigated the molecular mechanism of action of JI017 in human prostate cancer cells. We identified an endoplasmic reticulum (ER) stress pathway that depended on the reactive oxygen species (ROS) pathway and played a crucial role in JI017-induced apoptosis. We measured cell viability by the MTS assay to determine the effect of JI017. Analysis of apoptosis, mitochondrial dysfunction, and cell cycle features was performed by flow cytometry. We used western blot and RT-PCR to measure the levels of the proteins of the unfolded protein response (UPR) pathway and apoptosis markers. Immunoprecipitation assay and transfection were used to determine the expression levels of proteins interacting with the pathways influenced by JI017 in prostate cancer cells. The anticancer effects induced by JI017 were evaluated. JI017 induced cell death that regulated apoptotic molecules and caused cell cycle arrest that inhibited the proliferation of cancer cells. Moreover, JI017 generated ROS. Accumulation of ROS caused ER stress through the PERK–eIF2α–CHOP and IRE1α-CHOP pathways. Furthermore, persistent activation of the UPR pathway induced by JI017 treatment triggered mitochondrial dysfunction, including dissipation of mitochondrial membrane potential, which activated intrinsic apoptotic pathway in human prostate cancer cells. The data indicated that N-acetyl-L-cysteine diminished apoptosis. We demonstrated that JI017 induced ER stress and cell death. Anticancer properties of JI017 in prostate cancer cells and in a human prostate cancer model involved ROS-mediated ER stress. Thus, JI017 treatment provides a new strategy for chemotherapy of prostate cancer.

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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

Cited by 6 publications

References 9 publications

Study Protocol for Multi-Center, Open-Label, Randomized Controlled Trial for Assessing the Efficacy and Safety of Electroacupuncture for Cold Hypersensitivity in Hands and Feet

Study Protocol for Multi-Center, Open-Label, Randomized Controlled Trial for Assessing the Efficacy and Safety of Electroacupuncture for Cold Hypersensitivity in Hands and Feet

Efficacy and safety of Onkyeong-tang in treating cold hypersensitivity in the feet of Korean women: protocol for a double-blind, randomized, placebo-controlled, parallel-group, multicenter clinical study

In vitro Anticancer Effects of JI017 on Two Prostate Cancer Cell Lines Involve Endoplasmic Reticulum Stress Mediated by Elevated Levels of Reactive Oxygen Species

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