Effect of Yukgunja-tang on patients with functional dyspepsia classified by 3-Dimensional Facial Shape Diagnostic System

Effect of Yukgunja-tang on patients with functional dyspepsia classified by 3-Dimensional Facial Shape Diagnostic System: a randomized, double-blinded, placebo-controlled, multi-center clinical trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0001920

Enrollment

Registered

2016-05-16

Start date

2016-07-18

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 : HanShin Yukgunja-tang Granule was extracted from Koeran herbal medicine based on the preion of Yukgunja-tang by HanKookShinYak Pharmaceutical Co., Ltd. (Nonsan, Korea). patients in YT group wil

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Individuals between the ages of 19 and 75 years 2. Individuals who meet the Rome III functional dyspepsia criteria 3. Individuals who check more than 40 points on the visual analogue scale (0-100) for dyspeptic symptoms 4. Individuals who voluntarily agree with a study protocol and sign a written informed consent

Exclusion criteria

Exclusion criteria: 1. Individuals who have peptic ulcer or gastroesophageal reflux disease 2. Individuals who have obvious signs of irritable bowel syndrome 3. Individuals who have alarm symptoms (weight loss, black or tar stool, or dysphagia) 4. Individuals who have serious structural disease (malignant tumors, disease of heart, lung, liver or kidney) or mental illness 5. Individuals who have had surgery related with the gastrointestinal tract, except for appendectomy more than six months ago 6. Individuals who have other structural disease related with the gastrointestinal tract (e.g., cholangitis, pancreatitis) 7. Individuals who have had maxillofacial surgery or facial bone contouring surgery 8. Individuals who are taking drugs which might affect the gastrointestinal tract (Proton-pump inhibitors(PPIs), H2 antagonists, Antacids, gastrointestinal motility promoters, antibiotics, Nonsteroidal anti-inflammatory drugs(NSAIDs), muscle relaxants, antidepressants, stabilizer); a minimum wash-out period of one week is required before participating in the trial 9. Individuals who are pregnant or breastfeeding 10. Individuals who have a problem of malabsorption or maldigestion 11. Individuals who are human immunodeficiency virus(HIV) positive 12. Individuals who have difficulty in attending the trial (e.g., severe mental or psychological abnormality, dementia, drug addiction, time constraint, severe disorder in vision or hearing, outpatient treatment impossibility, illiteracy) 13. Individuals who have taken any other Investigational drug within 3 months

Design outcomes

Primary

Measure	Time frame
Total Dyspepsia Symptom(TDS) Scale	—

Secondary

Measure	Time frame
Single Dyspepsia Symptom(SDS) Scale;Visual Analogue Scale (VAS);Nepean Dyspepsia Index (NDI);Functional dyspepsia-related quality of life (FD-QoL);Spleen Qi Deficiency Questionnaire (SQDQ);Adequate relief(AR) of FD pain & discomfort	—

Countries

Korea, Republic of

Contacts

Public ContactSOO JEON

Dong-Eui University Oriental Medicine Hospital

jsoohyung@hanmail.net+82-51-850-8904

Outcome results