Safety profile and metabolic effects of Rosa damascena extract in patients with type II diabetes and healthy volunteers: A triple blind and acarbose controlled phase II and III clinical trial
Background: The worldwide increase in type 2 diabetes mellitus is becoming a major health concern. Rosa damascena extract had shown to have an intensive non-competitive inhibitory effect on α-glucosidase in an animal study. We aimed to assess the safety and efficacy of Rosa damascena (RD) Mill on blood sugar in diabetic and normal population.
Methods: Subjects were 12 men and 20 women aged 18 to 75 years with type II diabetes of at least 6 months duration who were drug naive as diabetic group; and 7 men and 21 women aged between 18 and 75 years non diabetic volunteers as healthy group.Inclusion criteria in diabetic patients were a body-mass index between 25 and 40 kg/m2, HbA1C between 6.5% and 8% and fasting blood sugar less than 200mg/dl. Exclusion criteria were pregnancy, breast feeding, renal or hepatic failure and uncontrolled or complicated diabetes.In a triple-blind, placebo and acarbose-controlled randomized trial, we randomly allocated diabetic patients and normal volunteers to 100 mg acarbose, 200 or 400 mg RD-methanolic extract or placebo daily. We followed up the participants for 15 days regarding the possible side effects and any changes in laboratory.parameters. Analyses were done by intention to treat.
General information
Acronym
Rosa damascena extract in patients with type II diabetes
IRCT registration information
IRCT registration number:IRCT138809221774N2
Registration date:2012-07-21, 1391/04/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-07-21, 1391/04/31
Registrant information
Name
Mojgan Sanjari
Name of organization / entity
Kerman University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 34 1322 2506
Email address
msanjari@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
kerman university of medical sciences
Expected recruitment start date
2009-03-20, 1387/12/30
Expected recruitment end date
2010-03-20, 1388/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety profile and metabolic effects of Rosa damascena extract in patients with type II diabetes and healthy volunteers: A triple blind and acarbose controlled phase II and III clinical trial
Public title
Safety profile and metabolic effects of Rosa damascena extract in patients with type II diabetes and healthy volunteers: A triple blind and acarbose controlled phase II and III clinical trial
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria in diabetic patients were a body-mass index between 25 and 40 kg/m2, HbA1C between 6.5% and 8% and fasting blood sugar less than 200mg/dl. Exclusion criteria were pregnancy, breast feeding, renal or hepatic failure and uncontrolled or complicated diabetes
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
kerman university of medical sciences
Street address
kerman university of medical sciences
City
kerman
Postal code
Approval date
2010-01-01, 1388/10/11
Ethics committee reference number
88.71
Health conditions studied
1
Description of health condition studied
diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Blood Sugar 2 Hours Postprandial
Timepoint
Days 0-8-15 after start of the internention
Method of measurement
mg/dl-analysor
2
Description
Fasting Blood Sugar
Timepoint
Days 0-8-15 after start of the internention
Method of measurement
mg/dl-analysor
3
Description
fructosamine
Timepoint
Days 0-15 after start of the intervention
Method of measurement
mg/dl-chromatography
Secondary outcomes
1
Description
urine analysis
Timepoint
days 0-8-15 ofter intervention
Method of measurement
microscopic & macroscopic - laboratory analyzer
2
Description
Complete Blood Count
Timepoint
Days 0-8-15 ofter intervention
Method of measurement
laboratory analyzer
3
Description
Haemoglobin A1C
Timepoint
days 0 of the study
Method of measurement
percent - nycocard reader2
4
Description
liver fanctional tests
Timepoint
days 0-8-15 ofter intervention
Method of measurement
mg/dl-laboratory analyzer
Intervention groups
1
Description
first group: swallowing of 200 mg Rosa damascena (RD)-methanolic extract daily for 15 days
Category
Treatment - Drugs
2
Description
second group:swallowing of 400 mg RD-methanolic extract daily for 15 days
Category
Treatment - Drugs
3
Description
third group: swallowing of placebo pills daily for 15 days
Category
Placebo
4
Description
forth group: swallowing of 100 mg acarbose daily for 15 days with lunch meal
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour hospital ,kerman Iran
Full name of responsible person
Dr. Mahboubeh Mashyekhi
Street address
Afzalipour hospital ,kerman Iran
City
kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kerman University of Medical Sciences PhYsiology resaerch center of
Full name of responsible person
Dr.Hamid Najafi pour
Street address
Physiology research center, Ebne sina Ave, Jahad Blvd, Kerman, Iran
City
kerman
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, Kerman University of Medical Sciences PhYsiology resaerch center of