Status:
UNKNOWN
Effect of Acupuncture on Patients With Functional Dyspepsia: a Multi-center, Randomized, Waitlist-controlled Trial
Lead Sponsor:
Kyunghee University Medical Center
Collaborating Sponsors:
Acupuncture and Meridian Science Research Center
Conditions:
Functional Dyspepsia
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The aim of the study is to investigate the effect of acupuncture treatment on functional dyspepsia.
Detailed Description
Functional dyspepsia (FD) is a functional gastrointestinal disorder without any structural lesion. FD is claimed to affect 25% of the population in South Korea. Although conventional approaches based ...
Eligibility Criteria
Inclusion
- Age of 18 \~ 75, with a elementary-school diploma or higher, should be able to read and write Korean
- One who meet Rome III FD criteria\* and has been suffering from FD for the last 3 months with symptom onset at least 6 months prior to diagnosis
- One or more of the following:
- Bothersome postprandial fullness
- Early satiation
- Epigastric pain
- Epigastric burning
- One who checks more than 4 points on visual analogue scale (VAS) for dyspeptic symptoms
- One who has normal esophagogastroduodenoscopy results within a year and been diagnosed with FD by a specialist consultation
- One who receives no other treatments during the study
- One who voluntarily agrees with study protocol and signs an written informed consent
Exclusion
- One who has peptic ulcer or gastroesophageal reflux disease (GERD)
- One who has obvious signs of irritable bowel syndrome (IBS)
- One who has alarm symptoms (weight loss, black or tar stool, dysphagia)
- One who has serious structural disease (disease of heart, lung, liver or kidney) or mental illness
- One who has had surgery related with the gastrointestinal tract (Appendectomy more than 6 months ago is acceptable)
- One who is pregnant or breastfeeding
- One who is taking drugs which might affect gastrointestinal tract (Wash-out period: 2 weeks before participating in the trial)
- One who is HIV-positive
- One who has a problem of malabsorption or maldigestion
- One who has difficulties in attending the trial or receiving treatments (e.g Paralysis, serious mental illness, dementia, drug addiction, busyness, severe disorder in vision or hearing, impossibility of visit, illiterate, etc.)
- One who does not want to sign the informed consents
- One who has clotting disorders or leukopenia, pace-maker, seizure disorders or is taking anticoagulant therapy
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2014
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT01921504
Start Date
August 1 2013
End Date
February 1 2014
Last Update
August 13 2013
Active Locations (2)
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1
Kyung Hee University Oriental Medicine Hospital
Seoul, Dongdaemun-gu, South Korea, 130-872
2
Kyung Hee University Hospital at Gangdong
Seoul, Gangdong-gu, South Korea, 130-701