Regulation and status of herbal medicine clinical trials in Korea

Lee, Boram; Choi, Yujin; Kim, Pyung-Wha; Yang, Changsop; Lee, Myeong Soo

doi:10.1016/j.imr.2020.100688

Cited by 11 publications

(6 citation statements)

References 11 publications

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“…Since the 1990s, the importance of evidence-based medicine (EBM) has grown to provide the best care for patients by integrating the experience of doctors with relevant scientific evidence. It is necessary to verify the therapeutic effect of KM through well-designed clinical trials to clarify the efficacy and safety according to EBM [ 19 , 20 ]. High-quality clinical trials are used to develop new drugs, evaluate the efficacy and safety of existing drugs, and enhance insurance coverage [ 20 ].…”

Section: Discussionmentioning

confidence: 99%

“…It is necessary to verify the therapeutic effect of KM through well-designed clinical trials to clarify the efficacy and safety according to EBM [ 19 , 20 ]. High-quality clinical trials are used to develop new drugs, evaluate the efficacy and safety of existing drugs, and enhance insurance coverage [ 20 ]. Evaluating the toxicity of SUEP is needed to justify clinical trials.…”

Section: Discussionmentioning

confidence: 99%

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Evaluation of Genotoxicity of SU-Eohyeol Pharmacopuncture Using an In Vitro Chromosome Aberration Test in Chinese Hamster Lung Cell

Ku¹,

Hwang

2022

J Pharmacopuncture

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Objectives This study was conducted to evaluate the safety of SU-Eohyeol pharmacopuncture (SUEP) by assessing its potential to cause chromosomal abnormalities in Chinese hamster lung cells (CHL/IC). Methods A dose-curve was conducted to determine the highest dose of SUEP. Doses of 10, 5, 2.5, 1.25, 0.625, and 0.313% were used, and no cytotoxicity or SUEP precipitation was observed. SUEP doses of 10, 5, and 2.5%, with positive and negative controls, were used in a chromosome aberration test. Results In this study, the frequency of abnormal chromosomal cells in the SUEP group did not show a statistically significant difference from that of the negative control group in short-term treatments with and without metabolic activation and the continuous treatment without metabolic activation. Compared with the negative control group, the positive control group had a significantly higher frequency of cells with structural chromosomal abnormalities. This test’s results satisfied all conditions for determining the results. Conclusion SUEP did not induce chromosomal aberrations under the conditions of this study. Other toxicity evaluations, safety studies in humans, and various clinical trials are required to evaluate the safety and efficacy of SUEP.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Evaluation of Genotoxicity of SU-Eohyeol Pharmacopuncture Using an In Vitro Chromosome Aberration Test in Chinese Hamster Lung Cell

Ku¹,

Hwang

2022

J Pharmacopuncture

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“…In particular, Maekmundong-tang has cough as an indication. In the Republic of Korea, a clinical trial is exempted from investigational new drug application if it targets a drug already approved by the Korean Ministry of Food and Drug Safety and is conducted within the scope of the indication permitted [14]. Therefore, pre-clinical data such as toxicity data are unnecessary for this type of clinical trial.…”

Section: Study Design and Recruitmentmentioning

confidence: 99%

Herbal Medicine Maekmundong-Tang on Patients with Nonspecific Chronic Cough: Study Protocol for a Double-Blind, Randomized Controlled Clinical Trial

Lee

Park

Jung

et al. 2023

IJERPH

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As the treatment of nonspecific chronic cough with conventional medications that treat cough according to the cause is limited, Maekmundong-tang (comprising Liriopis seu Ophiopogonis Tuber, Pinelliae Tuber, Oryzae Semen, Zizyphi Fructus, Ginseng Radix, and Glycyrrhizae Radix et Rhizoma) has been used empirically in the clinical setting of East Asian traditional medicine. This study is the first to explore the feasibility, preliminary effect, safety, and cost-effectiveness of Maekmundong-tang for nonspecific chronic cough. This study protocol is that of a double-blind, randomized, active-controlled, parallel-group clinical trial for comparing Maekmundong-tang with Saengmaek-san (comprising Liriopis seu Ophiopogonis Tuber, Ginseng Radix, and Schisandrae Fructus), a Korean national health insurance-covered herbal medicine for cough. A total of 30 nonspecific chronic cough patients will participate and receive the assigned herbal medicine for 6 weeks, and clinical parameters will be assessed at weeks 0 (baseline), 3 (midterm assessment), 6 (primary endpoint), 9, and 24 (follow-up). Study feasibility outcomes, including recruitment, adherence, and completion rates, will be assessed. Preliminary effects on cough severity, frequency, and quality of life will be evaluated using outcome measures, such as the Cough Symptom Score, Cough Visual Analog Scale, and the Leicester Cough Questionnaire. Adverse events and laboratory tests will be monitored for safety evaluation, and exploratory economic evaluations will be conducted. The results will provide evidence of Maekmundong-tang in the treatment of nonspecific chronic cough.

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“…It would be worth considering a health insurance for clinical trials on herbal medicines instead of trial insurance and indemnity, which comes at higher cost. In Korea, most of the clinical trials on herbal medicines were supported by national governments ( Lee et al, 2021 ). This would be recommendable for Ghana as well.…”

Section: Challenges Of Herbal Medicine Industry In Ghanamentioning

confidence: 99%

Ghana’s herbal medicine industry: prospects, challenges and ways forward from a developing country perspective

Asase

2023

Front. Pharmacol.

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The herbal medicine industry is one of the fastest growing industries in the world. However, no detailed assessments have been undertaken on how to achieve the benefits of this industry for developing countries. This study examined the herbal medicine industry in Ghana, with a particular focus on its prospects, challenges and ways forward. The prospects of the medicinal plant trade are huge, and include reducing the national health budget, being a source of foreign and domestic income, as well as creation of employment and poverty reduction. However, the industry is currently inundated with several challenges, such as registration of herbal medicine products and practitioners, a lack of clinical trials for herbal products, standards and quality control issues, shortage of raw plant materials for production, and insufficient scientific research to support traditional claims on the pharmacological effects of medicinal plants. I propose a number of interventions to address these challenges: increased government support, capacity building initiatives, improved regulation of herbal medicines, application of modern technology in the manufacturing of herbal products, large-scale cultivation of medicinal plants, and improved packaging and branding for herbal medicines. Both the national government and the private sector have crucial roles to deliver in the development of the herbal medicine industry in a country like Ghana.

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Regulation and status of herbal medicine clinical trials in Korea

Cited by 11 publications

References 11 publications

Evaluation of Genotoxicity of SU-Eohyeol Pharmacopuncture Using an In Vitro Chromosome Aberration Test in Chinese Hamster Lung Cell

Evaluation of Genotoxicity of SU-Eohyeol Pharmacopuncture Using an In Vitro Chromosome Aberration Test in Chinese Hamster Lung Cell

Herbal Medicine Maekmundong-Tang on Patients with Nonspecific Chronic Cough: Study Protocol for a Double-Blind, Randomized Controlled Clinical Trial

Ghana’s herbal medicine industry: prospects, challenges and ways forward from a developing country perspective

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