Observational study on the tongue image change of functional dyspepsia patients treated by Korean herbal medicine

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0002114

Enrollment

Registered

2016-10-21

Start date

2016-10-21

Completion date

Unknown

Last updated

2019-03-11

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

Conditions

None listed

Interventions

Drug : Oral administration of Buzhong Yiqi-Tang (Once per 2g, 6g/day, 4 weeks)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Age between 20 and 70 years 2) Meeting the definition of functional dyspepsia according to the Rome ? criteria 3) Functional dyspepsia symptoms over the last 6 months 4) Over 43.18 value by Buzhong Yiqi Tang questionnaire score 5) Patient who have no problem communication 6) Provide consent to participate in this study and sign an informed consent statement after listening to a clear explanation of the purpose and characteristics of this clinical study

Exclusion criteria

Exclusion criteria: 1) Individuals who have serious diseases: diseases of a digestive, kidney, heart, lung and metabolic disease, cancer 2) Individuals who have undergone surgery related to the gastrointestinal tract excluding an operation for appendicitis 3) Over Body Mass Index (BMI) ranging between 19.0 to 30 kg/m2 4) Patient who has taken other preion medicine or Korean herbal medicine within 4 weeks 5) Pregnant and lactating women 6) Severe psychological and mental illness patient, dementia and drug addiction 7) History of another clinical study within the previous 2 months 8) Patient who have abnormal value of blood test results (more than three times over the normal range) 9) Those with difficulty imposing a strict restriction on any oral activities (such as eating, brushing teeth, etc.) for at least 4 hours 10) Patients with hypersensitivity to the test drug 11) Disqualified as a suitable patient by Korean medicine doctor 12) Anyone considered inappropriate for participating in this trial by the clinical study conductors

Design outcomes

Primary

Measure	Time frame
Functional dyspepsia quality of life score	—

Secondary

Measure	Time frame
Tongue coating thickness (%);Result of blood sampling;Spleen qi deficiency questionnaire score	—

Countries

Korea, Republic of

Contacts

Public ContactHyun Ho Kim

Kyung Hee University

mechante@hanmail.net+82-2-958-9242

Outcome results