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A human study to evaluate the effect of Platycodi radix water extract on blood triglyceride levels

A human study to evaluate the effect of Platycodi radix water extract on blood triglyceride levels: an 8-week, randomized, placebo-controlled, double-blind, parallel study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0002861
Enrollment
96
Registered
2018-05-10
Start date
2018-03-07
Completion date
Unknown
Last updated
2020-04-21

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 : After the 2-week run-in period, enrolled subjects will be randomly assigned to treatment or placebo groups at visit 2 (week 0). The subjects will be asked to consume 1 pack (80ml/

Sponsors

Ewha Womans University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Subject who voluntarily agree to participate and signs informed consent form 2) Men and women over 20 years old (ratio of men and women 1:1) 3) Blood triglyceride levels less than 200mg/dL 4) Subject who comply with dietary and lifestyles guidelines for intervention period

Exclusion criteria

Exclusion criteria: 1) Continuous consumption of health functional food(phytosterol, omega-3 fatty acid, plantagis Semen, aloe, kito acid, onion extract, Indigestible maltodextrin, pure cuttlefish oil, globin hydrolysate), medicine(Lipid-lowering agents, blood glucose-lowering drugs, antihypertensive drugs, anti-inflammatory agents, anticoagulant drug), and oriental medicine that affect blood glucose, lipid, body fat metabolism within 1 months before the first visit 2) History or current abuse of alcohol, or intake = 420 g pure alcohol/week. (e.g. more than 7 bottles of soju/week). 3) Following diseases ? Liver dysfunction, Diabetes, renal dysfunction, interstinal disease, lactose intolerance, chronic inflammatory disease, thyroid disease, severe muscular skeletal disease ? Severe wasting diseases: malignant tumor ? Mental diseases: schizophrenia, depression ? Cardiovascular and cerebrovascular diseases: hypertension(systolic blood pressure = 160 mmHg, diastolic blood pressure = 100 mmHg), myocardial infarction, stroke ? Anemia, asthma and allergic diseases 4) Women who maintaining hormone therapy 5) Participation in weight management program or weight loss of more than 10% of body weight ? 6) regulary excessive exercise more than 10 hours/week 7) excessive smoking more than 20 cigarettes/day 8) Recommended food score more than 36 9) Body mass index (kg/m2) less than 20 or more than 30 10) Known hypersensitivity to study product or any ingredient in study product 11) Participation in another clinical trial within 4 weeks of enrollment into the study. 12) Pregnant or lactating women 13) Subject who has difficult to handle smartphone 14) Any condition that the Principal Investigator believes may put the subject at undue risk

Design outcomes

Primary

MeasureTime frame
Blood triglyceride;Total cholesterol, VLDL cholesterol, LDL cholesterol and HDL cholesterol;Apolipoprotein B48

Secondary

MeasureTime frame
Blood glucose;Insulin

Countries

Korea, Republic of

Contacts

Public ContactSeunghee Kang

Ewha Womans University

Outcome results

None listed

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