Protocol summary
-
Study aim
-
This study aims to investigate the effect of Melissa officinalis extract on glycemic status, lipid profile, apolipoprotein B, apolipoprotein A1, total antioxidant capacity and hs-CRP in patients with type II diabetes.
-
Design
-
Patients will be randomly assigned two groups. In the intervention group, patients will receive two capsules containing 350 mg Melissa officinalis extract per day for 3 months. patients in the control group will receive two capsules containing 350 mg toasted flour twice daily for 3 months.
Laboratory tests including glycemic status, lipid profile, apolipoprotein B, apolipoprotein A1, total antioxidant capacity and hs-CRP , also blood pressure and anthropometric indices will be measured at baseline and at the end study. Also, the dietary intakes and physical activity will be measured.
-
Settings and conduct
-
In this randomized double-blinded placebo-control clinical trial 70 patients with type 2 diabetes referring to the Iranian Diabetes Society and Institute of Endocrinology and Metabolism will be included.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria are: Patients aged 20 to 65 years for both sexes; BMI less than 35 kg/m2; no pregnancy or lactation; TG less than 400 mg/dl; HbA1c < % 8; using oral hypoglycemic agents. Exclusion criteria are: possess of any co-disorders including cardiovascular, liver, renal, allergic and infectious diseases as well as thyroid disorders and glaucoma; taking NSAIDS drugs or estrogen and progesterone.
-
Intervention groups
-
Intervention group: Taking orally 2 capsules of 350 mg Mellissa officinalis extract per day for 3 months. Capsules are provided in Institute of Medicinal Plants affiliated with ACECR.
Placebo group: Taking orally 2 similar capsules of toasted flour.
-
Main outcome variables
-
FBS, Fasting insulin, Total antioxidant capacity, Apo A-1, Apo B, HbA1c, TG, TC, HDL-C, LDL-C, hs-CRP, Insulin resistance (HOMA-IR)
General information
-
Reason for update
-
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT201701162709N41
Registration date:
2017-05-17, 1396/02/27
Registration timing:
prospective
Last update:
2018-03-25, 1397/01/05
Update count:
1
-
Registration date
-
2017-05-17, 1396/02/27
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
Vice Chancellor for Research, Iran University Of Medical Sciences
-
Expected recruitment start date
-
2017-05-22, 1396/03/01
-
Expected recruitment end date
-
2017-08-23, 1396/06/01
-
Actual recruitment start date
-
2017-05-22, 1396/03/01
-
Actual recruitment end date
-
2017-11-01, 1396/08/10
-
Trial completion date
-
empty
-
Scientific title
-
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
-
Public title
-
Effects of lemon balm extract on glycemic criteria, lipid profile, hs-CRP and antioxidant status in patients with type II diabetes
-
Purpose
-
Treatment
-
Inclusion/Exclusion 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:
-
Age
-
From 20 years old to 65 years old
-
Gender
-
Both
-
Phase
-
N/A
-
Groups that have been masked
-
- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
-
Sample size
-
Target sample size:
70
Actual sample size reached:
62
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
The patients will be categorized in two groups by random allocation.
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
The patients will be categorized into three groups by random allocation.
-
Placebo
-
Used
-
Assignment
-
Parallel
-
Other design features
-
The patients will be categorized in three groups by random allocation.
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2017-01-09, 1395/10/20
-
Ethics committee reference number
-
IR.IUMS.REC 1395.9411468001
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
-
FBS
-
Timepoint
-
Before the experiment and 12 weeks after intervention
-
Method of measurement
-
Enzymatic method
2
-
Description
-
Fasting insulin
-
Timepoint
-
Before the experiment and 12 weeks after intervention
-
Method of measurement
-
ELISA
3
-
Description
-
Total antioxidant capacity
-
Timepoint
-
Before the experiment and 12 weeks after intervention
-
Method of measurement
-
Colorimetry (FRAP)
4
-
Description
-
Apo A-1
-
Timepoint
-
Before the experiment and 12 weeks after intervention
-
Method of measurement
-
Immunoturbidimetry
5
-
Description
-
Apo B
-
Timepoint
-
Before the experiment and 12 weeks after intervention
-
Method of measurement
-
Immunoturbidimetry
6
-
Description
-
HbA1c
-
Timepoint
-
Before the experiment and 12 weeks after intervention
-
Method of measurement
-
High Performance Liquid Chromatography
7
-
Description
-
TG
-
Timepoint
-
Before the experiment and 12 weeks after intervention
-
Method of measurement
-
Enzymatic method
8
-
Description
-
TC
-
Timepoint
-
Before the experiment and 12 weeks after intervention
-
Method of measurement
-
Enzymatic method
9
-
Description
-
HDL-C
-
Timepoint
-
Before the experiment and 12 weeks after intervention
-
Method of measurement
-
Enzymatic method
10
-
Description
-
LDL-C
-
Timepoint
-
Before the experiment and 12 weeks after intervention
-
Method of measurement
-
Friedewald formula
11
-
Description
-
hs-CRP
-
Timepoint
-
Before the experiment and 12 weeks after intervention
-
Method of measurement
-
ELISA
12
-
Description
-
Insulin resistance (HOMA-IR)
-
Timepoint
-
before the experiment and 12 weeks after intervention
-
Method of measurement
-
Formula
Secondary outcomes
1
-
Description
-
BP
-
Timepoint
-
Before the experiment and 12 weeks after intervention
-
Method of measurement
-
Mercury 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
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Vice Chancellor for Research, Iran University Of Medical Sciences
-
Proportion provided by this source
-
100
-
Public or private sector
-
Public
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Academic
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Undecided - It is not yet known if there will be a plan to make this available
-
Study Protocol
-
No - There is not a plan to make this available
-
Statistical Analysis Plan
-
Undecided - It is not yet known if there will be a plan to make this available
-
Informed Consent Form
-
Undecided - It is not yet known if there will be a plan to make this available
-
Clinical Study Report
-
Undecided - It is not yet known if there will be a plan to make this available
-
Analytic Code
-
Undecided - It is not yet known if there will be a plan to make this available
-
Data Dictionary
-
Undecided - It is not yet known if there will be a plan to make this available