Effects of lemon balm extract on glycemic criteria, lipid profile, hs-CRP and antioxidant status in patients with type II diabetes

Effects of lemon balm extract on glycemic criteria, lipid profile, apolipoprotein B, apolipoprotein A-1, antioxidant capacity and hs-CRP in comparison with control group in patients with type II diabetes

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT201701162709N41

Enrollment

Registered

2017-05-17

Start date

2017-05-22

Completion date

Unknown

Last updated

2018-04-30

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

Conditions

Type 2 diabetes mellitus. Non-insulin-dependent diabetes mellitus

Interventions

Intervention 1: Intervention group: Taking orally 2 herbal capsules of 350 mg mellissa officinalis extract per day ( one after Lunch and one after Dinner) for 3 months. Capsules are provided in Instit

Eligibility

Sex/Gender

All

Age

20 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria are: Patients aged 20 to 65 years for both sexes; The body mass index less than 35 kg/m2; no pregnancy or lactation; triglycerides less than 400 mg/dl; HbA1c < % 8; using a common diabetes drug (metformin and glibenclamide). Exclusion criteria are: Lack of any co-disorders including cardiovascular, liver, renal, allergic and infectious diseases as well as thyroid disorders and glaucoma; taking non steroidal anti-inflammatory drugs (NSAIDS) or estrogen and progesterone.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
FBS. Timepoint: Before the experiment and 12 weeks after intervention. Method of measurement: Enzymatic method.;Fasting insulin. Timepoint: Before the experiment and 12 weeks after intervention. Method of measurement: ELISA.;Total antioxidant capacity. Timepoint: Before the experiment and 12 weeks after intervention. Method of measurement: Colorimetry (FRAP).;Apo A-1. Timepoint: Before the experiment and 12 weeks after intervention. Method of measurement: Immunoturbidimetry.;Apo B. Timepoint: Before the experiment and 12 weeks after intervention. Method of measurement: Immunoturbidimetry.;HbA1c. Timepoint: Before the experiment and 12 weeks after intervention. Method of measurement: High Performance Liquid Chromatography.;TG. Timepoint: Before the experiment and 12 weeks after intervention. Method of measurement: Enzymatic method.;TC. Timepoint: Before the experiment and 12 weeks after intervention. Method of measurement: Enzymatic method.;HDL-C. Timepoint: Before the experiment and 12 weeks after intervention. Method of measurement: Enzymatic method.;LDL-C. Timepoint: Before the experiment and 12 weeks after intervention. Method of measurement: Friedewald formula.;Hs-CRP. Timepoint: Before the experiment and 12 weeks after intervention. Method of measurement: ELISA.;Insulin resistance (HOMA-IR). Timepoint: before the experiment and 12 weeks after intervention. Method of measurement: Formula.	—

Measure

Time frame

FBS. Timepoint: Before the experiment and 12 weeks after intervention. Method of measurement: Enzymatic method.;Fasting insulin. Timepoint: Before the experiment and 12 weeks after intervention. Method of measurement: ELISA.;Total antioxidant capacity. Timepoint: Before the experiment and 12 weeks after intervention. Method of measurement: Colorimetry (FRAP).;Apo A-1. Timepoint: Before the experiment and 12 weeks after intervention. Method of measurement: Immunoturbidimetry.;Apo B. Timepoint: Before the experiment and 12 weeks after intervention. Method of measurement: Immunoturbidimetry.;HbA1c. Timepoint: Before the experiment and 12 weeks after intervention. Method of measurement: High Performance Liquid Chromatography.;TG. Timepoint: Before the experiment and 12 weeks after intervention. Method of measurement: Enzymatic method.;TC. Timepoint: Before the experiment and 12 weeks after intervention. Method of measurement: Enzymatic method.;HDL-C. Timepoint: Before the experiment and 12 weeks after intervention. Method of measurement: Enzymatic method.;LDL-C. Timepoint: Before the experiment and 12 weeks after intervention. Method of measurement: Friedewald formula.;Hs-CRP. Timepoint: Before the experiment and 12 weeks after intervention. Method of measurement: ELISA.;Insulin resistance (HOMA-IR). Timepoint: before the experiment and 12 weeks after intervention. Method of measurement: Formula.

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Secondary

Measure	Time frame
BP. Timepoint: Before the experiment and 12 weeks after intervention. Method of measurement: Mercury sphygmomanometer.;Body mass index. Timepoint: Before the experiment and 12 weeks after intervention. Method of measurement: Weight (kg) /height2 (m2).;Weight. Timepoint: Before the experiment and 12 weeks after intervention. Method of measurement: Seca scale.;Waist circumference. Timepoint: Before the experiment and 12 weeks after intervention. Method of measurement: Elastic tape.;Physical activity. Timepoint: Before intervention and 6 and 12 weeks after intervention. Method of measurement: International Physical Activity Questionarre.;Energy intake. Timepoint: Before intervention and 6 and 12 weeks after intervention. Method of measurement: 24-hour dietary recall.	—

Measure

Time frame

BP. Timepoint: Before the experiment and 12 weeks after intervention. Method of measurement: Mercury sphygmomanometer.;Body mass index. Timepoint: Before the experiment and 12 weeks after intervention. Method of measurement: Weight (kg) /height2 (m2).;Weight. Timepoint: Before the experiment and 12 weeks after intervention. Method of measurement: Seca scale.;Waist circumference. Timepoint: Before the experiment and 12 weeks after intervention. Method of measurement: Elastic tape.;Physical activity. Timepoint: Before intervention and 6 and 12 weeks after intervention. Method of measurement: International Physical Activity Questionarre.;Energy intake. Timepoint: Before intervention and 6 and 12 weeks after intervention. Method of measurement: 24-hour dietary recall.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarzad Shidfar

Iran University Of Medical Science

shidfar.f@iums.ac.ir+98 21 8670 4711

Outcome results

None listed

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