The infusion of Rosa canina fruit is used in the folk medicine of Iran, Turkey and some other countries for rheumatoid arthritis, influenza, gastrointestinal diseases and also diabetes mellitus. Its hypoglycemic effects have been shown in experimental studies. The objective of this study is to assess the hypoglycemic effects of this herb in type 2 diabetic patients. In this study 60 patients with type 2 diabetes mellitus taking hypoglycemic drugs (except of insulin) with fasting blood glucose (FBG) more than 126 and less than 250 mg/dl, hemoglobin A1C (HbA1c) more than 6, without hepatic, renal and cardiac diseases and not pregnant, allocated in two groups randomly. Patients in group 1 take capsules of powdered aqueous extract of Rosa canina fruit 750 mg BD orally for 3 months. Patients in second group take placebo capsules which filled with corn starch BD orally for 3 months. FBG, 2 hours postprandial blood glucose (PBG) and HbA1c will be measured before and 2 months after interventions and two groups will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138803061957N2
Registration date:2012-09-12, 1391/06/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-09-12, 1391/06/22
Registrant information
Name
Fataneh Hashem Dabaghian
Name of organization / entity
Research Institute for Islamic and Complementary Medicine
Country
Iran (Islamic Republic of)
Phone
+98 21 3395 0152
Email address
fatanehdabaghian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Research institute for Islamic and complementary medicine
Expected recruitment start date
2012-03-10, 1390/12/20
Expected recruitment end date
2013-03-10, 1391/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Rosa canina extract in type 2 Diabetic patients
Public title
Hypoglycemic effects of Rosa canina
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Type 2 diabetes mellitus, Fasting blood glucose (FBG) more than 126 and less than 250 mg/dl, Hemoglobin A1C (HbA1c) more than 6, Taking routine hypoglycemic therapy (except of insulin), Singing written informed consent and Exclusion criteria: Three or more than 3 episodes of hypoglycemia in the previous week, Cardiac, hepatic or renal diseases, Pregnancy
Age
From 35 years old to 60 years old
Gender
Both
Phase
2
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
Randomization will be done by "Block Randomization” method. Practitioners and patients are blind about type of interventions. Both drug and placebo capsules are similar in shape, size and color. Both groups take their interventions twice daily.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Research Institute for Islamic and Complementary Medicine
Intervention: Capsules of 750 mg powdered aqueous extract of Rosa canina twice daily by mouth for 2 months. Drug was prepared in the laboratory of traditional medicine in" Research Institute for Islamic and Complementary Medicine”. Effective ingredients of this drug have not been evaluated.
Category
Treatment - Drugs
2
Description
Control: Capsules of 750 mg corn starch twice daily by mouth for 2 months. Groups are similar in shape and color of capsules.