Protocol summary

Summary
This study aims to investigate the effect of Melissa officinalis extract on depression, anxiety, sleep quality and hs-CRP in comparison with control group in patients with type II diabetes and depression. In this randomized double-blinded placebo-control clinical trial 60 patients with type 2 diabetes with depression reffering to the Institute of Endocrinology and Metabolism will be included. 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. Patients will be randomly assigned to intervention or control groups. In intervention group, patients will receive capsules containing 350 mg Melissa officinalis extract twice per day for 3 months. While, patients at the control group will receive placebo capsules containing 350 mg toasted flour twice daily during 3 months. All laboratory test including fasting blood sugar and hs-CRP , in addition Severity of depression and anxiety (by Beck inventory for depression and anxiety), sleep quality (by Pittsburgh sleep quality questionnaire), blood pressure and anthropometric indices will be measured at baseline and week 12 of the study. Also, the dietary intakes and physical activity will be measured.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201709239472N16
Registration date: 2017-10-09, 1396/07/17
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-10-09, 1396/07/17
Registrant information
Name
Naheed Aryaeian
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4750
Email address
aryaeian.n@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
private sector
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
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
Purpose
Treatment
Inclusion/Exclusion 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.
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The patients will be categorized in three groups by random allocation.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Iran University Of Medical Science
Street address
Hemmat highway,Tehran,Iran
City
Tehran
Postal code
Approval date
2017-08-28, 1396/06/06
Ethics committee reference number
IR.IUMS.FMD.REC 1396.9413468004

Health conditions studied

1

Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E10, E11,
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
Sleep quality
Timepoint
Before the experiment and 12 weeks after intervention
Method of measurement
Pittsburgh Sleep Quality Index

2

Description
Depression
Timepoint
Before the experiment and 12 weeks after intervention
Method of measurement
Beck Depression Questionnaire

3

Description
FBS
Timepoint
Before the experiment and 12 weeks after intervention
Method of measurement
Enzymatic method

4

Description
hs-CRP
Timepoint
Before the experiment and 12 weeks after intervention
Method of measurement
ELISA

5

Description
Anxiety
Timepoint
Before the experiment and 12 weeks after intervention
Method of measurement
Beck Anxiety Questionnaire

Secondary outcomes

1

Description
BP
Timepoint
Before the experiment and 12 weeks after intervention
Method of measurement
Digital sphygmomanometer

2

Description
Body mass index
Timepoint
Before the experiment and 12 weeks after intervention
Method of measurement
Weight (kg) /height2 (m2)

3

Description
Weight
Timepoint
Before the experiment and 12 weeks after intervention
Method of measurement
Seca scale

4

Description
Waist circumference
Timepoint
Before the experiment and 12 weeks after intervention
Method of measurement
Elastic tape

5

Description
Physical activity
Timepoint
Before intervention and 6 and 12 weeks after intervention
Method of measurement
International Physical Activity Questionarre

6

Description
Energy intake
Timepoint
Before intervention and 6 and 12 weeks after intervention
Method of measurement
24-hour dietary recall

Intervention groups

1

Description
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 Plants affiliated with ACECR
Category
Treatment - Drugs

2

Description
Placebo group: Taking orally 2 similar capsules of toasted flour per day for 3 months
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
The Institute of Endocrinology and Metabolism Research (Iran University Of Medical Sciences)
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
private
Full name of responsible person
Mostafa Safari
Street address
Iran University of Medical Sciences, next to the Tower and Milad Hospital, Hemmat Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
private
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University Medical of Scienses
Full name of responsible person
Mostafa Safari
Position
Student Masters
Other areas of specialty/work
Street address
Iran University of Medical Sciences, next to the Tower and Milad Hospital, Hemmat Highway
City
Tehran
Postal code
Phone
+98 25 3882 5181
Fax
Email
mo.safari68@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University Medical of Scienses
Full name of responsible person
Nahid Aryaeian
Position
associate professor
Other areas of specialty/work
Street address
Iran University of Medical Sciences, next to the Tower and Milad Hospital, Hemmat Highway
City
Tehran
Postal code
Phone
+98 912 309 3353
Fax
Email
n-aryaeian@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
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Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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