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Efficacy and safety evaluation study of Oryeongsan for stage I primary hypertension

Efficacy and safety evaluation study of Oryeongsan for stage I primary hypertension: Multicenter randomized, double-blind, placebo-controlled, parallel design Investigator initiated exploratory clinical trials

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0009705
Enrollment
24
Registered
2024-08-14
Start date
2023-06-15
Completion date
Unknown
Last updated
2025-05-07

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

Conditions

None listed

Interventions

Drug : Oryeongsan or placebo, for 8 weeks, dissolve 1 pack (4g) in water 3 times a day and take orally between breakfast, lunch and dinner

Sponsors

Wonkwang University, Gwangju Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Aged = 19 years old 2) Before Randomized, if either of the following applies - 140 mmHg =MSSBP < 160 mmHg - 90 mmHg = MSDBP < 100 mmHg 3) Those who are not currently taking anti-hypertensive medication and who have not taken medication for hypertension within the last 4 weeks 4) Those who have the ability and willingness to voluntarily agree to take part in the clinical trial and participate in the test

Exclusion criteria

Exclusion criteria: 1) At screening and randomized, MSSBP = 160 mmHg or MSDBP = 100 mmHg 2) At screening, SSBP difference is = 20 mmHg and SDBP difference= 10mmHg 3) Known or suspected secondary hypertension(ex. aortic coarctation, hyperaldosteronism, renal artery stenosis, Cushing's syndrome, pheochromocytoma, polycystic kidney disease) 4) Patients with orthostatic hypotension with symptoms 5) Unregulated diabetes (Excluding patients who do not need diabetes medication during the study period) 6) Patients with severe heart disease, ischemic heart disease within 6months, peripheral vascular disease, Percutaneous Transluminal Coronary Angiography (PTCA), Coronary Artery Bypass Graft (CABG) 7) Patients with significant ventricular tachycardia, atrial fibrillation, atrial flutter or other significant arrhythmia 8) Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, immunologically significant aortic or mitral stenosis 9) Subject with severe cerebrovascular disease (infarct, hemorrage) ithin recent 6 months. 10) known severe or malignant retinopathy(retinal hemorrhage, visual disturbance, Retinal microaneurysms and so on within 6 months) 11) Patients with wasting disease, autoimmune disease, connective tissue disease at present and/or previous 12) There is clinically significant kidney or liver disease defined by the following laboratory parameters: - renal dysfunction(CCr < 30 mL/min, Serum creatinine = 2 mg/dL or UNL X 1.5) - hepatic dysfunction(AST/ALT = UNL X 3) 13) Patients with surgical and medical disease it is able to be affect to absorption, distribution, metabolism, excretion 14) Patients who are dependent on drugs or alcohol 15) Childbearing and breast-feeding women, A female patient whose pregnancy was confirmed by a pregnancy test of urine specimen. Female who plan to become pregnancy or have a possibility of pregnancy but don't prevent conception with acknowledged methods 16) chronic inflammatory status need to treatment 17) Persons with known or suspected hypersensitivity reactions to the test substance or the same class of drug 18) Those who participated in other studies within 3 months before screening. 19) Those who drank on the day of study participation, those who consumed caffeine drinks within 1 hour 20) Subject who the opinion investigator make a judgment to be unsuitable for any other reason

Design outcomes

Primary

MeasureTime frame
Amount of change in SBP in experimental group and control group;Amount of change in DBP in experimental group and control group;rates of patients achieving a therapeutic goal in the two groups at termination;blood pressure response rates in the two groups at termination

Secondary

MeasureTime frame
Amount of change in health-related quality of life;liver and renal function test

Countries

Korea, Republic of

Contacts

Public ContactSe young Kim

Wonkwang University

kimse0@hanmail.net+82-62-670-6790

Outcome results

None listed

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