Effectiveness and safety of Rosa Canina in treatment of patients with Type 2 Diabetes Mellitus

Comparison of safety and effectiveness of Herbi Norm400 (Produced By Persian Darou Company) with standard treatment (Metformin and exercise) in decreasing percent of glycated hemoglobin in patients with Type 2 Diabetes Mellitus

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2015122317994N4

Enrollment

110

Registered

2016-08-04

Start date

2016-04-18

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

Non-insulin-dependent diabetes mellitus. Non-insulin-dependent diabetes mellitus

Interventions

Treatment - Drugs

Intervention 1: Diet, exercise, Metformin 500 mg tablets (depending on the degree of the disease, from one to three tablets per day) plus placebo capsule three times a day for 24 weeks. Intervention 2

Placebo

Diet, exercise, Metformin 500 mg tablets (depending on the degree of the disease, from one to three tablets per day) plus placebo capsule three times a day for 24 weeks.

Diet, exercise, Metformin 500 mg tablets (depending on the degree of the disease, from one to three tablets per day) plus placebo Herbi norm400 three times a day (one hour before or two hours after a

Eligibility

Sex/Gender

All

Age

40 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria:Patients with diagnosed Type 2 diabetes mellitus (at least 3 months and a maximum of 5 years passed from diagnosis)); Age of patients 40 to 65 years; Glycosylated hemoglobin is less than 8%; The patient is treated with Metformin; The patient sign a consent form. Exclusion criteria:Insulin therapy; Type 1 diabetes patients; Patients who take complete dose of metformin (4 metformin 2000mg); Patients who take drugs that suppress the immune system; Pregnant, lactating women or women of childbearing potential who are not willing to use adequate contraception; Untreated thyroid disease patients; Kidney disease patients (and / or the level of liver enzymes ALT, AST greater than 3 times the normal value); Glomerular Filtration Rate (GFR) less than 60cc per min; Psychological disorders that cause any inability to cope with study protocol; Patients who take variable (not fixed) medications used to treat or reduce the symptoms of Type 2 Diabetes Mellitus.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Changes in the glycated hemoglobin at week 24 compared to baseline. Timepoint: Monthly for 6 months. Method of measurement: laboratory kit.	—

Secondary

Measure	Time frame
Fasting plasma glucose. Timepoint: Monthly for 6 months. Method of measurement: laboratory kit.;Post-prandial plasma glucose (PPG) after 2h. Timepoint: Monthly for 6 months. Method of measurement: laboratory kit.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMansour Shamsipour

Environment Research center

+98 21 0098

Outcome results

None listed

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