ReviewIntegrative medicine research2021
Regulation and status of herbal medicine clinical trials in Korea: a narrative review.
Review in Integrative medicine research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed.
- Efficacy and safety of modified Gwakjeongtang (herbal medicine) for diarrhea-predominant irritable bowel syndrome: A randomized, double-blind, placebo-controlled trial.Integrative medicine research · 2026Article
- Ethical challenges of placebo use in herbal medicine trials: multiple stakeholder perspectives from qualitative interviews.BMC medical ethics · 2026Article
- Effectiveness and Safety of an Herbal Medicine Strategy for Chronic Low Back Pain: Protocol for a Prospective, Multicenter, Pragmatic, Randomized, Non-Inferiority Trial.Journal of pain research · 2026Article
- Review
- Prevalence of herbal medicine consumption and regulatory compliance in some selected districts of the Bono region, Ghana.BMC complementary medicine and therapies · 2025Article
- Similar but Different Three Major Traditional Medicines in East Asia: A Bibliometric Analysis.Chinese journal of integrative medicine · 2025Article
- Traditional herbal medicine legislative and regulatory framework: a cross-sectional quantitative study and archival review perspectives.Frontiers in pharmacology · 2025Article
- Evaluation of compliance of CONSORT-CHM formula 2017 in randomized controlled trials of Chinese herbal medicine formulas: protocol of a five-year review.Frontiers in pharmacology · 2024Article
- Herbal MedicineInternational journal of environmental research and public health · 2023Article
- Ghana's herbal medicine industry: prospects, challenges and ways forward from a developing country perspective.Frontiers in pharmacology · 2023Article
- Evaluation of Genotoxicity of SU-Eohyeol Pharmacopuncture Using an In Vitro Chromosome Aberration Test in Chinese Hamster Lung Cell.Journal of pharmacopuncture · 2022Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundHerbal medicine has been used frequently in Korean medicine. We aimed to summarize the relevant regulations for herbal medicine clinical trials and to analyze their current status in the Republic of Korea.
methodsWe searched for legislation to find regulations on herbal medicine clinical trials. Additionally, the websites of the Korean Ministry of Food and Drug Safety (KMFDS) and Clinical Research Information Service (CRIS) were searched to investigate the current status of them.
resultsTo conduct herbal medicine clinical trials for new drugs or previously approved drugs outside of indications, investigational new drug (IND) approval should be obtained from the KMFDS. For clinical trials of herbal medicines that have been used for more than 3 years with 200 cases at the clinical trial institution, nonclinical data can be exempted from IND approval. Total 95 and 108 herbal medicine clinical trials from the KMFDS and CRIS websites were analyzed. The number of clinical trials showed an increasing trend each year, as did KMFDS-regulated clinical trials. Recently, three clinical trials targeting new herbal formulations frequently used in Korean medicine institutions have been approved based on relevant regulations.
conclusionWe confirmed that herbal medicine clinical trials are managed through strict regulations, which can ensure the safe and effective use of herbal medicine. Despite strict regulations, attempts to accumulate evidence through clinical trials for herbal medicine are increasing. High-quality clinical trials should be conducted to develop new drugs that reflect the clinical setting using relevant regulations, evaluate the efficacy and safety of the drugs, and strengthen insurance coverage.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.