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A Prospective Observational Study on the Efficacy, Safety, and Cost-effectiveness of Korean Medicine Treatment for Functional Dyspepsia in Korean Medicine Hospitals

Safety, Efficacy, and Cost-effectiveness of Traditional Korean Medicine for Functional Dyspepsia: A Multi-center Prospective Observational Study in Korean Medicine Hospitals

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0010148
Enrollment
300
Registered
2025-01-24
Start date
2024-12-04
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Kyung Hee University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Adults aged 19-74 years old - Those who meet the ROME IV criteria for functional dyspepsia: presenting with one or more symptoms including postprandial fullness, early satiety, epigastric pain, epigastric burning, which developed at least 6 months prior and persisted for the last 3 months, with no structural abnormalities explaining these symptoms - Those who are currently receiving or planning to receive Korean medicine treatment for functional dyspepsia - Those who, after receiving sufficient explanation about the study participation, voluntarily agreed to participate and signed the IRB-approved written consent form

Exclusion criteria

Exclusion criteria: - Those diagnosed with organic diseases (peptic ulcer, gastroesophageal malignancy, pancreatobiliary disease, etc.) that explain current clinical symptoms based on upper endoscopy (EGD) or routine tests (blood tests, imaging) - History of gastrointestinal surgery (except appendectomy if performed >6 months ago) - Presence of alarm symptoms: severe weight loss, bloody stool, dysphagia, odynophagia, persistent vomiting - Serious organic diseases (e.g., heart, lung, liver, kidney diseases, malignancy) - History of or current major neuropsychiatric conditions (e.g., major depressive disorder, anxiety disorder, schizophrenia) - Pregnant, nursing, or unwilling to use proper contraception - History of serious drug or alcohol abuse - Current participation in other clinical trials (except those deemed non-interfering by researcher) - Those deemed unsuitable for participation by the principal investigator for other reasons

Design outcomes

Primary

MeasureTime frame
Functional dyspepsia symptom (Nepean Dyspepsia Index - Korean version);Overall Treatment Effect

Secondary

MeasureTime frame
Dyspepsia symptom score (Numeric Rating Scale);Quality of life (EQ-5D-5L);Medical expenses associated with functional dyspepsia;Safety(adverse events);Safety(blood and urine tests);Safety(vital signs)

Countries

Korea, Republic of

Contacts

Public ContactHaein Jeong

Kyung Hee University Oriental Medical Center

hatsal93@naver.com+82-2-958-9140

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026