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Investigation of traditional-Iranian medicine(Nigella sativa , Trigonella foenum- graecum, Rhus coriaria , Portulaca oleracea ) products on blood sugar in type II diabetic patients

The effect of a traditional Iranian medicine product (fenugreek + black cumin + sumac + comfrey) on the control of blood sugar indicators in patients with type II diabetes compared to the placebo group

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20141027019705N5
Enrollment
72
Registered
2025-02-18
Start date
2025-04-04
Completion date
Unknown
Last updated
2025-07-21

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 due to underlying condition

Interventions

Intervention 1: Intervention group: The intervention group, under the supervision of a relevant specialist, in addition to common diabetes treatments, received 6 capsules daily containing 4 plants: bl

Sponsors

Arak University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients with type 2 diabetes FBS 2- Fasting blood sugar equal to or higher than 126 mg to 200 mg per deciliter or random sugar equal to or higher than 180 mg per deciliter HgbA1c: 6.5 to 9 - Use of oral hypoglycemic drugs (no insulin) No use of sulfonylurea drugs: Amaryl (Glimipride), Donil (Glibenclamide), Diamicron (Gilclazide), Minodiab (Glipizide), Tolbutamide, Tolazamide and glucocorticoids (Glipizide) Gilbenes Taking a fixed dose of oral hypoglycemic drugs for at least the past 3 months Not receiving enteral or parenteral nutrition Not pregnant or breastfeeding Individuals with a body mass index above 18.5 Not having kidney, liver, cardiovascular, thyroid or cancer disease aged 20 to 65 years old

Exclusion criteria

Exclusion criteria: Having a specific disease that could interfere with the study process Allergy to the plants studied Following a special diet or taking supplements Using Oral contraceptive pill

Design outcomes

Primary

MeasureTime frame
Fasting blood glucose. Timepoint: Before the intervention begins and at the beginning of the study, all subjects will have their blood sugar levels measured. After 8 weeks of administering the intervention, all subjects will be retested using the same method and at the same initial location, and the results will be compared. Method of measurement: Fasting blood sugar is measured by enzymatic colorimetric method. Fasting insulin is measured by enzyme immunoassay method. The QUIKI index is used to calculate insulin sensitivity. To calculate the QUIKI index, fasting insulin is used in U/mlµ scale and fasting glucose is used in mg/dl scale: QUIKI = 1 / [log (FI) + log (FG)] To calculate insulin resistance, the HOMA-IR index is used. To calculate the HOMA-IR index, fasting insulin is used in U/lµ scale and fasting glucose is used in /l nmol scale: HOMA-IR = fasting insulin (µU/L) x fasting glucose (nmol/L)/22.5.;Lipid profile. Timepoint: Before the intervention begins and at the beginning of the study, all individuals will be examined for their lipid profile, and after 8 weeks of administering the desired intervention, all individuals will be retested using the same method and at the same initial location for the second phase of testing, and the results will be compared. Method of measurement: Serum cholesterol, LDL, HDL, TG are measured by colorimetric enzymatic method.;Liver enzume. Timepoint: Before the intervention begins and at the beginning of the study, all subjects' liver enzymes will be measured, and after 8 weeks of administering the desired intervention, all subjects will be retested using the same method and at the same initial location for the second phase of tests, and the results will be compared. Method of measurement: AST, ALT, and ALP are measured by the colorimetric method.

Secondary

MeasureTime frame
Blood sugar indices. Timepoint: Before the intervention, that is, at the beginning of the study, patients will be evaluated for blood sugar. After 8 weeks from the start of the intervention, all individuals will be retested using the same method and at the same initial location for the second phase of tests, and the results will be compared. Method of measurement: At the beginning and end of the study, FBS (fasting blood sugar), and fasting insulin, were measured after a 12-hour fast and two indices QUIKI and HOMA-IR were calculated. FBS was measured by the enzymatic colorimetric method. Fasting insulin was measured by the enzyme immunoassay method. The QUIKI index was used to calculate insulin sensitivity. To calculate the QUIKI index, fasting insulin was used in the U/mlµ scale and fasting glucose was used in the mg/dl scale:QUIKI = 1 / [log (FI) + log (FG)]The HOMA-IR index was used to calculate insulin resistance. To calculate the HOMA-IR index, fasting insulin in U/lµ and fasting glucose in nmol/l are used: HOMA-IR = fasting insulin (µU/L) x fasting glucose (nmol/L)/22.5.;Lipid profile indices. Timepoint: Before the intervention, that is, at the beginning of the study, patients will be evaluated for lipid profile. After 8 weeks from the start of the intervention, all individuals will be retested using the same method and at the same initial location for the second phase of tests, and the results will be compared. Method of measurement: At the beginning and end of the study, serum cholesterol, LDL, HDL, and TG are measured using the enzymatic colorimetric method.;Liver functional enzymes. Timepoint: Before the intervention, that is, at the beginning of the study, patients will be evaluated for liver functional enzymes. After 8 weeks from the start of the intervention, all individuals will be retested using the same method and at the same initial location for the second phase of tests, and the results will be compared. Method of measurement: At the beginning and

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMehdi Salehi

Arak University of Medical Sciences

m_salehi@razi.tums.ac.ir+98 918 364 8352

Outcome results

None listed

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