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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT138809221774N2

Enrollment

Registered

2012-07-21

Start date

2009-03-20

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

diabetes mellitus. Non-insulin-dependent diabetes mellitus

Interventions

Intervention 1: first group: swallowing of 200 mg Rosa damascena (RD)-methanolic extract daily for 15 days. Intervention 2: second group:swallowing of 400 mg RD-methanolic extract daily for 15 days. I

Treatment - Drugs

Placebo

first group: swallowing of 200 mg Rosa damascena (RD)-methanolic extract daily for 15 days

second group:swallowing of 400 mg RD-methanolic extract daily for 15 days

third group: swallowing of placebo pills daily for 15 days

forth group: swallowing of 100 mg acarbose daily for 15 days with lunch meal

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Blood Sugar 2 Hours Postprandial. Timepoint: Days 0-8-15 after start of the internention. Method of measurement: mg/dl-analysor.;Fasting Blood Sugar. Timepoint: Days 0-8-15 after start of the internention. Method of measurement: mg/dl-analysor.;Fructosamine. Timepoint: Days 0-15 after start of the intervention. Method of measurement: mg/dl-chromatography.	—

Secondary

Measure	Time frame
Urine analysis. Timepoint: days 0-8-15 ofter intervention. Method of measurement: microscopic & macroscopic - laboratory analyzer.;Complete Blood Count. Timepoint: Days 0-8-15 ofter intervention. Method of measurement: laboratory analyzer.;Haemoglobin A1C. Timepoint: days 0 of the study. Method of measurement: percent - nycocard reader2.;Liver fanctional tests. Timepoint: days 0-8-15 ofter intervention. Method of measurement: mg/dl-laboratory analyzer.	—

Measure

Time frame

Urine analysis. Timepoint: days 0-8-15 ofter intervention. Method of measurement: microscopic & macroscopic - laboratory analyzer.;Complete Blood Count. Timepoint: Days 0-8-15 ofter intervention. Method of measurement: laboratory analyzer.;Haemoglobin A1C. Timepoint: days 0 of the study. Method of measurement: percent - nycocard reader2.;Liver fanctional tests. Timepoint: days 0-8-15 ofter intervention. Method of measurement: mg/dl-laboratory analyzer.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mojgan Sanjari

Kerman university of Medical sciences

msanjari@kmu.ac.ir+98 341322225070

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026