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The effects of Silybum marianum (L.) Gaertn. (Silymarin) supplement consumption on metabolic status, Hs-CRP and oxidative stress in type 2 diabetic patients with overweight or obesity

The effects of Silybum marianum (L.) Gaertn. (Silymarin) supplement consumption on metabolic status, Hs-CRP and oxidative stress in type 2 diabetic patients with overweight or obesity

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201309243140N13
Enrollment
40
Registered
2013-11-16
Start date
2013-10-23
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Type 2 diabetes. Non-insulin-dependent diabetes mellitus

Interventions

Intervention 1: Intervention group will receive daily 3 tablets of silymarin with meal for 45 days (each tablets of silymarin contains 140 milligrams pure silymarin). silymarin tablets will be purchas
Goldaru Herbal Products Pharmaceutical Company. All the patients will receive the tablets on every two weeks base and will be monitored for consumption continuation and any possible adverse effects by
Treatment - Drugs
Placebo
Intervention group will receive daily 3 tablets of silymarin with meal for 45 days (each tablets of silymarin contains 140 milligrams pure silymarin). silymarin tablets will be purchased from the Live
The control group will receive daily 3 tablets of placebo with meal for 45 days. (Placebo tablets will be produced at the faculty of pharmacy of Tabriz University of medical sciences).

Sponsors

Vice chancellor for Research, Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 50 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Type 2 diabetes for at least 6 months; age between 20-50 (both of gender) years and usage of blood glucose lowering drugs. Exclusion criteria: usage of nutritional supplements in the past 3 months or during the study; usage of insulin; Pregnancy or lactation; BMI more than 35 and lower than 27; Renal and liver failure; Cardiovascular disease; Thyroid disorders; History of allergy; Smoking; Alcohol usage; Following a specific diet; Taking corticosteroids or Immunosuppressive drugs,…

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Fasting blood glucose. Timepoint: Baseline and after 45 days of intervention. Method of measurement: Enzymatic colorimetric.;Insulin resistance. Timepoint: Baseline and after 45 days of intervention. Method of measurement: HOMA-IR calculation.;Fasting insulin serum. Timepoint: Baseline and after 45 days of intervention. Method of measurement: ELISA assay.;Lipid profiles (TC, TG, LDL-C, HDL-C). Timepoint: Baseline and after 45 days of intervention. Method of measurement: Enzymatic methods for TC,TG and HDL-C For LDL-C : Freidwald’s formula: LDL-C = TC- HDL-C - (TG/5).;Hs-CRP. Timepoint: Baseline and after 45 days of intervention. Method of measurement: immunoturbidimetry.;Serum malondialdehyde (MDA). Timepoint: Baseline and after 45 days of intervention. Method of measurement: spectrophotometry.;Serum total antioxidant capacity. Timepoint: Baseline and after 45 days of intervention. Method of measurement: spectrophotometry.;GPX activity. Timepoint: Baseline and after 45 days of intervention. Method of measurement: spectrophotometry.;SOD activity. Timepoint: Baseline and after 45 days of intervention. Method of measurement: spectrophotometry.

Secondary

MeasureTime frame
Calorie and nutrients intake. Timepoint: before and after 45 dyas intervention. Method of measurement: 24-h recall Questionnaire.;Anthropometric index(weight, height,WHR and Body Mass. Timepoint: before and after 45 days intervention. Method of measurement: Analogue scale for weight and weight(Kg)/Square Height for body mass index.;Systolic and diastolic blood pressure. Timepoint: before and after 45 days intervention. Method of measurement: standard barometer.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSoraiya Ebrahimpour Koujan

Tabriz University of Medical Sciences

nutri.seam1@gmail.com00

Outcome results

None listed

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