ClinicalTrials.gg
Status unknownNCT00839085Updated Feb 10, 2009

Comparison of Ascorbic Acid and Grape Seed Extract in Oxidative Stress Induced by on Pump Heart Surgery

An interventional study of GSE and Vit C (Ascorbic Acid) in CABG-Induced Oxidative Stress, sponsored by Tabriz University. Status unknown at 1 site in Iran. Per ClinicalTrials.gov, last updated 2009-02-10.

Sponsored by Tabriz University · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Feb 2009), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Sex
All
01

Study summary

Study aimed to compare the effect of grape seed extract and ascorbic acid in oxidative stress induced by on pump coronary artery by pass grafting surgery.

Read the detailed description

This study aimed to compare the effect of grape seed extract and ascorbic acid in oxidative stress induced by on pump coronary artery by pass grafting surgery.

There are three groups in the study. 75 candidate of coronary artery by pass grafting surgery were assigned random allocation on the groups (25 in each group).

  1. Control
  2. GSE (100 mg/6h - PO, 24h before surgery)
  3. Vit C (25 mg/kg in pump circulation during surgery)
02

Conditions studied

  • CABG-Induced Oxidative Stress

Keywords

  • CABG
  • on pump
  • Grape seed extract
  • Vit C
  • Oxidative stress
03

In context

Lead sponsor

Tabriz University is the lead sponsor of 16 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Candidates for elective CABG surgery with pump for first time
  • 3VD

Exclusion criteria

Exclusion Criteria:

  • High risk patients
  • Those who need another heart surgery beside CABG
  • Urgent patients
  • Diabetics
  • Ischemic time more than 120 min
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
72 participants (actual)

Study arms

  • No intervention
    1

    normal procedure of CABG

  • Active comparator
    2: GSE

    100 mg GSE every 6h /Po, starting one day before surgery (4 doses in 24h)

    Drug: GSE

  • Active comparator
    3: Vit C

    25 mg/kg through pump

    Drug: Vit C (Ascorbic Acid)

Interventions

  • DrugGSE

    grape seed extract (100 mg/6h), PO

    Also known as: Grape Seed Extract

  • Vit C 25 mg/ kg

    Also known as: Ascorbic Acid

06

What researchers measure

Primary outcomes

  1. LVEF

    Time frame: Before and after CABG

Secondary outcomes

  1. Total Antioxidant Capacity (TAC)

    Time frame: Before ischemia, after ischemia, after reperfusion

  2. MDA

    Time frame: Before, middle and after CABG

  3. GTX

    Time frame: Before ischemia, after ischemia, after reperfusion

  4. SOD

    Time frame: Before ischemia, after ischemia, after reperfusion

07

Study locations

1 site
  • Cardiovascular Research Center
    Tabriz, East Azerbaijan Province 51656-65811, Iran
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00839085
Lead sponsor
Tabriz University
First posted
Feb 9, 2009
Start date
Nov 2008
Primary completion
Jan 2009 (estimated)
Completion
Mar 2009 (estimated)
Last update
Feb 10, 2009

Study contacts

Hossein Babaei, Pharm D, PhD
principal investigator · Drug Applied Research Center, Tabriz Univ Med Sci
Naser Safaei, MD, Surgeon
study chair · Tabriz Univ Med Sci
Masood Pezaeshkian, MD
principal investigator · Tabriz Univ Med Sci
Alireza Yaghobi, MD
principal investigator · Tabriz Univ Med Sci
Ahmad Reza Jodati, MD
principal investigator · Tabriz Univ Med Sci
Hossein Babaei, Pharm D, PhD
study director · Tabriz Univ Med Sci
Rasoul Azarfarin, MD
principal investigator · Tabriz Univ Med Sci
Mohammad Ali Sheikhalizadeh, CCP
study director · Tabriz Univ Med Sci

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Grape Seed Extract · Ascorbic Acid

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