Efficacy and safety study of WSY-S

A 12 week, multi-center, double-blind, randomized, placebo-controlled clinical trial for the evaluation of the efficacy and safety of WSY-S on treatment of stomach health

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0003761

Enrollment

Registered

2019-04-12

Start date

2018-12-10

Completion date

Unknown

Last updated

2019-04-23

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

Conditions

None listed

Interventions

Dietary Supplement : This study was designed to assess the efficacy and safety of gastric health when adults with functional dyspepsia ingested WSY-S (Chinese yam extract) compared to placebo. The stu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Men and women over 20 years old and under 70 years old 2) Those diagnosed with functional dyspepsia (Rome IV *)

Exclusion criteria

Exclusion criteria: 1) Patients with a history of severe malignancy, cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), heart disease (angina, myocardial infarction, heart failure, arrhythmia requiring treatment) within the past 6 months. (In the case of a stable subject, the examiner can include those subjects by judgment.) 2) Those with a history of peptic ulcer and reflux esophagitis within 6 months 3) Patients who had previous gastric acid suppression surgery or gastroesophageal surgery 4) Patients with a history of gastrointestinal malignancies 5) Within 2 weeks of the start of the study, a combination of an H2 receptor blocker, an anticholinergic agent (muscarinic receptor antagonist), a gastrin receptor antagonist, a prostaglandin agent, a proton pump inhibitor, a gastric mucosal protective agent 6) Persons who are to continue taking medications that may cause gastritis, such as corticosteroids, non-steroidal anti-inflammatory drugs, and aspirin 7) Drinker: for men who consumed more than 14 units of alcohol per week and for women who consumed more than 7 units of alcohol per week during the past month 8) Patients with uncontrolled hypertension (over 160 / 100mmHg, measured after 10 minutes of test subjects) 9) Unregulated diabetic patients (fasting blood sugar 180 mg/dl or more) 10) Creatinine is at least twice the normal upper normal limit 11) AST/ALT is at least three times the normal upper limit of the test laboratory. 12) Patients with uncontrolled thyroid disease 13) Those planning to become pregnant within 3 months, during pregnancy or lactation 14) Those who have participated in another human application test within one month, or are planning to participate in another human application test during this human application period 15) Any person deemed inappropriate for this study

Design outcomes

Primary

Measure	Time frame
Gastrointestinal Symptom Rating Scale (GSRS)	—

Secondary

Measure	Time frame
Nepean dyspepsia index-Korean version, World Health Organization Quality of Life Assessment Instrument	—

Countries

Korea, Republic of

Contacts

Public ContactJae Myung Cha

Kyung Hee University Hosipital at Gangdong

clicknox@hanmail.net+82-2-440-6113

Outcome results