deltatrials
Unknown PHASE3 INTERVENTIONAL 3-arm NCT01483430

Effect of Ginseol Kg1 on Blood Pressure Lowering

Effect of Ginseol Kg1 on Blood Pressure Lowering in Prehypertensive or Stage I Hypertensive Patients: Multicenter, Randomized, Placebo-controlled, Double-blind Study

Sponsor: DongGuk University

Updated 7 times since 2017 Last updated: Nov 30, 2011 Started: Sep 30, 2011 Primary completion: Jun 30, 2012 Completion: Dec 31, 2012
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01483430, this PHASE3 trial focuses on Hypertension, Stage I and Prehypertension and remains ongoing. Sponsored by DongGuk University, it has been updated 7 times since 2011, reflecting limited change activity. This study contributes longitudinal data to the cardiovascular research landscape.

Study Description(click to expand)

This is a multicenter, randomized, placebo-controlled, double-blind study. At the end of an initial 2-week washout period, patients fulfilling the inclusion criteria are assigned to three groups, i.e. control group (placebo), low dose Ginseol Kg1 group (100mg), or high dose Ginseol Kg1 (300mg) group. They will intake the study drug for 8 weeks. 24-h ambulatory BP monitoring (ABPM) and pulse wave velocity are measured at the end of the washout period and after 8 weeks of active treatment. At each visit, seated SBP and DBP, heart rate, use of concomitant medication and spontaneously reported adverse events are recorded. Compliance with medication (determined by counting returned tablets) is evaluated at each visit.

This is a multicenter, randomized, placebo-controlled, double-blind study. At the end of an initial 2-week washout period, patients fulfilling the inclusion criteria are assigned to three groups, i.e. control group (placebo), low dose Ginseol Kg1 group (100mg), or high dose Ginseol Kg1 (300mg) group. They will intake the study drug for 8 weeks. 24-h ambulatory BP monitoring (ABPM) and pulse wave velocity are measured at the end of the washout period and after 8 weeks of active treatment. At each visit, seated SBP and DBP, heart rate, use of concomitant medication and spontaneously reported adverse events are recorded. Compliance with medication (determined by counting returned tablets) is evaluated at each visit.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotUnknown Status~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotUnknown Status~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotUnknown Status~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotUnknown~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotUnknown~Sep 2025 – present · 7 months · monthly snapshotUnknown~Jan 2026 – present · 3 months · monthly snapshotUnknown

Change History

7 versions recorded
  1. Jan 2026 — Present [monthly]

    Unknown PHASE3

  2. Sep 2025 — Present [monthly]

    Unknown PHASE3

  3. Sep 2024 — Sep 2025 [monthly]

    Unknown PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Unknown PHASE3

    Status: Unknown StatusUnknown

  5. Jan 2021 — Jul 2024 [monthly]

    Unknown Status PHASE3

Show 2 earlier versions
  1. Jun 2018 — Jan 2021 [monthly]

    Unknown Status PHASE3

  2. Jan 2017 — Jun 2018 [monthly]

    Unknown Status PHASE3

    First recorded

Sep 2011

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • DongGuk University
  • Seoul National University Hospital
Data source: Seoul National University Hospital

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations