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Effect of motilitone on gastrointestinal symptoms in patients with type 2 diabetes mellitus

Effect of motilitone on gastrointestinal symptoms and continuous glucose measurement in patients with type 2 diabetes with functional dyspepsia.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0007103
Enrollment
60
Registered
2022-03-21
Start date
2022-03-29
Completion date
Unknown
Last updated
2022-04-04

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

Conditions

None listed

Interventions

Drug : Use of motilitone as a test drug : corydalis tuber(5), pharbitis seed(1) 50% EtOH extracts 30mg Use of gasmotine as an active control agent
mosapride citrate dihydrate 5mg Both interventions are taken orally 3 times a day

Sponsors

Kyung Hee University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Adults 18 years of age or older 2) Those with type 2 diabetes who are being controlled with oral medications (biguanide, sulfonylurea, alpha-glucosidase inhibitor, thiazolidinedione, meglitinide, metformin combination, DPP-4 inhibitor) 3) Those who have not changed their diabetes medication in the last 3 months, HbA1c < 9% or less, and have a change within ±0.5 from HbA1C before 3 months 4) Those diagnosed with postprandial distress syndrome of functional dyspepsia according to Rome IV diagnostic criteria (in case of postprandial bloating or early feeling of fullness more than 3 days a week, beginning 6 months ago and lasting for 3 months or more ) 5) Those who have agreed to participate in this exam

Exclusion criteria

Exclusion criteria: 1) Those who are being treated with insulin preparations or GLP1 receptor agonists for the treatment of diabetes 2) In case of diabetic renal dysfunction or diabetic retinopathy 3) Those who have confirmed organic digestive diseases (eg gastric ulcer, duodenal ulcer, esophageal cancer, gastric cancer, enteritis, colitis, etc.) 4) If you have had gastrectomy or vagus nerve resection in the past, and if other lesions that can cause gastrointestinal symptoms are found 5) If you are taking drugs that may affect the exercise evaluation of the digestive system 6) In case of impaired liver function (AST, ALT 2.5 times the upper limit of normal) 7) Persons with serious active medical conditions that may affect quality of life measures (thyroid disease, wasting or infectious disease, active cancer disease, acute respiratory disease, chronic active rheumatism and autoimmune disease, heart failure (NYHA II - IV) Or myocardial infarction, those with cardiovascular stents, etc.) 8) Pregnant, lactating, and women of childbearing age who do not use appropriate contraceptive methods 9) Others, those who are judged inappropriate by the principal investigator or the person in charge

Design outcomes

Primary

MeasureTime frame
Amount of improvement in the symptom questionnaire (NDI-K symptom score)

Secondary

MeasureTime frame
Amount of improvement in the symptom questionnaire (NDI-K symptom score)

Countries

Korea, Republic of

Contacts

Public ContactSuk Chon

Kyung Hee University Hospital

imdrjs@khu.ac.kr+82-2-958-8200

Outcome results

None listed

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