ClinicalTrials.gg
CompletedNCT03437902Updated May 16, 2018

Impact of Rutin and Vitamin C Combination on Oxidative Stress, Insulin Sensitivity and Lipid Profile in Type 2 Diabetic Patients

A Phase 2/3 interventional study of Rutin in combination with Vitamin C and Vitamin C in Type 2 Diabetes Mellitus, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2018-05-16.

Sponsored by Ain Shams University · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
53
Allocation
Randomized
Ages
35 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 130 studies in Diabetes Mellitus, Type 2 with a site in Egypt — 18 open to participants now, 21 under way, 5 of them phase 3. Diabetes Mellitus, Type 2 · Egypt.

Enrollment
80th of 98
53 · median 80
Started
2018
with 10 others
Phase 2/3
4 of 130
2 open now
Registered
28th of 130
by date
Lead sponsor
8 of 130
Ain Shams University

Among the 130 studies in Diabetes Mellitus, Type 2 with a site in Egypt, this one is the 80th largest by enrollment of the 98 interventional ones that give a count, is one of 11 that started in 2018, is one of 4 in phase 2/3, and was the 28th registered.

Diabetes Mellitus, Type 2

10,378 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.

Browse Diabetes Mellitus, Type 2 studies →

Open to participants now

18 of the 130 studies in Diabetes Mellitus, Type 2 with a site in Egypt are open now. Recruiting first, the newest first:

13 more — sign in →

All 18 open studies →

A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →

Who these studies take

Of the 883 Diabetes Mellitus, Type 2 studies recruiting now, 373 (42%) set no upper age limit and 384 (43%) stop at 75 or younger; 52 take children under 18; 203 take healthy volunteers.

This study: 35 Years and older · all sexes · no healthy volunteers.

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02

Study summary

The objective of this study is to investigate the effect ofRutin and Vitamin C combination in comparison with vitamin C alone on the oxidative and antioxidative status , insulin resistance and lipid profile in type 2 diabetic patients.

03

Conditions studied

  • Type 2 Diabetes Mellitus

Keywords

  • Type 2 diabetes
  • Rutin
  • Vitamin C
  • oxidative stress
  • Insulin resistance
  • lipid profile
04

Who can participate

Ages eligible
35 Years and older
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

    • Patients' age 35 years or older having type 2 diabetes mellitus.

      • Patients taking oral diabetic medications (Sulfonylurea) not taking Insulin.
      • Able to understand and willing to sign a written document

Exclusion criteria

Exclusion Criteria:

    • Pregnant and breast feeding females

      • use of vitamin supplements containing vitamin C or other antioxidants.
  • patients with renal or hepatic failure.
  • patients taking insulin as antidiabetic treatment
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
53 participants (actual)

Study arms

  • Experimental
    Rutin C group

    patients will receive Rutin 60 mg in combination with vitamin C 160 mg three times daily in addition to usual antidiabetic treatment for 8 weeks..

    Dietary Supplement: Rutin in combination with Vitamin C

  • Experimental
    Vitamin C group

    patients will receive vitamin C 500 mg once daily in addition to usual antidiabetic treatment for 8 weeks.

    Dietary Supplement: Vitamin C

  • No intervention
    Control group

    patients will receive their usual antidiabetic treatment only for 8 weeks.

Interventions

  • Dietary supplementRutin in combination with Vitamin C

    Drug pages: Rutin · Ascorbic Acid

    Rutin and Vitamin C will be supplied as tablets containing 60 mg Rutin and 160 mg Vitamin C. The use of Rutin and Vitamin C will be under the trade name of RUTA C 60 ® manufactured by KAHIRA PHARM.\& CHEM. IND. Company

  • Dietary supplementVitamin C

    Vitamin C will be supplied as capsules containing500 mg of Vitamin C. The use of Vitamin C will be under the trade name of C-Retard ® manufactured by HIKMA Quality Company.

    Also known as: Ascorbic acid

06

What researchers measure

Primary outcomes

  1. Oxidative stress marker (MDA) and antioxidant capacity (SOD) in diabetic patients

    Effect of Rutin and vitamin C combination or vitamin C alone on oxidative stress marker (MDA) and on antioxidant capacity (SOD) in diabetic patients after 8 weeks of treatment.

    Time frame: Two months

  2. Insulin resistance in diabetic patients .

    Effect of Rutin and vitamin C combination or vitamin C alone on insulin resistance in diabetic patients before i and after treatment for 8 weeks .

    Time frame: Two months

  3. Lipid profile in diabetic patients (TC,TG,HDL-c,LDL-c).

    Impact of Rutin and vitamin C combination or vitamin C alone on lipid profile in diabetic patients (TC,TG,HDL-c,LDL-c).

    Time frame: Two months

Secondary outcomes

  1. Quality of life of diabetic patients and this will be evaluated by using Quality of Life Questionnaire (Short Form 36 questions (SF-36)) .

    The effect of Rutin and vitamin C combination on quality of life of diabetic patients before and after treatment for 8 weeks and this will be evaluated by using Quality of Life Questionnaire (Short Form 36 questions (SF-36)) .

    Time frame: Two months

07

Study locations

1 site
  • Ain Shams University
    Cairo, Egypt
08

References and documents

Publications

  • Ragheb SR, El Wakeel LM, Nasr MS, Sabri NA. Impact of Rutin and Vitamin C combination on oxidative stress and glycemic control in patients with type 2 diabetes. Clin Nutr ESPEN. 2020 Feb;35:128-135. doi: 10.1016/j.clnesp.2019.10.015. Epub 2019 Nov 14. PubMed 31987106 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2018 to primary completion in May 2018, 2 months.

Of 26 non-industry phase 2/3 interventional studies under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 30. This study's 2 months is below that.

Counting every sponsor, half of 32 studies reached it within 22 months; a quarter within 13 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 10, 2018
First posted
Feb 19, 2018
StartActual
Feb 24, 2018
Primary completionActual
May 15, 2018
CompletionActual
May 15, 2018
Last update
May 16, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 16, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03437902
Responsible party
sara ramzy ragheb (Assistant Lecturer, Ain Shams University) — Principal investigator
First posted
Feb 19, 2018
Start date
Feb 24, 2018
Primary completion
May 15, 2018
Completion
May 15, 2018
Last update
May 16, 2018

Study contacts

sara R Ragheb, master
principal investigator · Ain Shams University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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