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Effectiveness of Liversil an herbal medicine in reducing insulin dependence in type 2 diabetic patients

Investigating the effectiveness of Liversil an herbal medicine (Silybum marianum seed extract) in reducing insulin dependence in type 2 diabetic patients in a clinical trial.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20080901001157N21
Enrollment
116
Registered
2024-09-07
Start date
2024-09-22
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Diabetes. Type 2 diabetes mellitus

Interventions

Intervention 1: Intervention group: Patients in this group take one capsule of 240 mg Liversil in the morning and one capsule at night after meals. Intervention 2: Control group: Patients in this grou

Sponsors

Iranian academic center for education culture and research
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 60 Years

Inclusion criteria

Inclusion criteria: Insulin-dependent type 2 diabetic patients with mild to moderate severity Age 60-40 years Having type 2 diabetes treated with insulin with diabetic diet or/with blood sugar lowering drugs Their fasting blood glucose level should not be more than 160 mg/dl with medication or diet At least 2 months before the start of the study, the average level of fasting blood glucose should not be more than 160 mg/dl and HbA1c should not be more than 8.5 percent. Signing the consent form to participate in the project

Exclusion criteria

Exclusion criteria: Patients with diabetic foot ulcer and gangrene or any serious illness (including renal failure, chronic liver failure, heart failure, pulmonary infection and proliferative retinopathy) Painful diabetic neuropathy Active neoplastic disease History of cancer less than 5 years Patients with depression Smoking and alcohol patients and patients who tend to change a specific exercise or diet program.

Design outcomes

Primary

MeasureTime frame
Glycosylated hemoglobin. Timepoint: At starting of the study and after 3 months. Method of measurement: Glycosylated hemoglobin will be determined in laboratory by commercial standard kit.;Insulin unit required daily. Timepoint: At starting of the study and after 3 months. Method of measurement: Insulin unit is measured by insulin syringe.;Fasting blood glucose. Timepoint: At starting of the study and after 3 months. Method of measurement: Blood glucose level will be determined in laboratory by commercial standard kit.

Secondary

MeasureTime frame
Triglyceride. Timepoint: At starting of the study and after 3 months. Method of measurement: Blood triglyceride level will be determined in laboratory by commercially available kit.;Cholesterol. Timepoint: At starting of the study and after 3 months. Method of measurement: Blood cholesterol level will be determined in laboratory by commercially available kit.;Low-density lipoprotein. Timepoint: low-density lipoprotein. Method of measurement: Blood low-density lipoprotein level will be determined in laboratory by commercially available kit.;High-density lipoprotein. Timepoint: At starting of the study and after 3 months. Method of measurement: Blood High-density lipoprotein level will be determined in laboratory by commercially available kit.;Aspartate aminotransferase. Timepoint: At starting of the study and after 3 months. Method of measurement: Blood aspartate aminotransferase level will be determined in laboratory by commercially available kit.;Alanine aminotransferase. Timepoint: At starting of the study and after 3 months. Method of measurement: Blood alanine aminotransferase level will be determined in laboratory by commercially available kit.;Blood urea nitrogen. Timepoint: At starting of the study and after 3 months. Method of measurement: Blood blood urea nitrogen level will be determined in laboratory by commercially available kit.;Creatinine. Timepoint: At starting of the study and after 3 months. Method of measurement: Blood creatinine level will be determined in laboratory by commercially available kit.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFallah Huseini Hasan

Iranian academic center for education culture and research

huseini_fallah@yahoo.com+98 26 3476 4010

Outcome results

None listed

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