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Effects of lemon balm extract on depression, anxiety, sleep quality and hs-CRP in comparison with control group in patients with type II diabetes and depression

Effects of lemon balm extract on depression, anxiety, sleep quality and hs-CRP in comparison with control group in patients with type II diabetes and depression

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201709239472N16
Enrollment
60
Registered
2017-10-09
Start date
2017-10-23
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 mellitus. Non-insulin-dependent diabetes mellitus

Interventions

Treatment - Drugs
Placebo
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 Institute of Medicinal
Placebo group: Taking orally 2 similar capsules of toasted flour per day for 3 months

Sponsors

private
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria are: getting at least 11 scores in the Beck Depression Inventory (BDI-II); 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), anti depression or estrogen and progesterone.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Sleep quality. Timepoint: Before the experiment and 12 weeks after intervention. Method of measurement: Pittsburgh Sleep Quality Index.;Depression. Timepoint: Before the experiment and 12 weeks after intervention. Method of measurement: Beck Depression Questionnaire.;FBS. Timepoint: Before the experiment and 12 weeks after intervention. Method of measurement: Enzymatic method.;Hs-CRP. Timepoint: Before the experiment and 12 weeks after intervention. Method of measurement: ELISA.;Anxiety. Timepoint: Before the experiment and 12 weeks after intervention. Method of measurement: Beck Anxiety Questionnaire.

Secondary

MeasureTime frame
BP. Timepoint: Before the experiment and 12 weeks after intervention. Method of measurement: Digital 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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMostafa Safari

Iran University Medical of Scienses

mo.safari68@gmail.com+98 25 3882 5181

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 9, 2026