Berberine and Cinnamon in Management of Diabetes
Primary Purpose
Diabetes
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Berberine+Cinnamon
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes focused on measuring Diabetes, Berberine, Cinnamon
Eligibility Criteria
Inclusion Criteria:
- Age 20-65 years
- Diagnosed type-2 diabetes mellitus during the last 1 years
- Currently only taking oral antidiabetic agents for the last 3 months
- HbA1c 6.5-8.0%
Exclusion Criteria:
Patients with an allergy to berberine /cinamon
- Patients using insulin therapy
- Patients with raised baseline serum creatinine level (>1.5 mg/dl in men or > 1.2 mg/dl in women)
- Lactation, pregnancy
- Patients with any malignancy
- Patients with unrelated chronic illness
- Patients with cardiac, liver or respiratory failure
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Intervention
Placebo
Arm Description
Outcomes
Primary Outcome Measures
HbA1C
HbA1C change from baseline
Secondary Outcome Measures
Fasting blood sugar
Blood sugar change from baseline
blood Insulin
insulin change from baseline
Lipid profile
lipid profiles change from baseline
Full Information
NCT ID
NCT05570357
First Posted
October 2, 2022
Last Updated
October 5, 2022
Sponsor
National Nutrition and Food Technology Institute
1. Study Identification
Unique Protocol Identification Number
NCT05570357
Brief Title
Berberine and Cinnamon in Management of Diabetes
Official Title
The Effects of Berberine and Cinnamon Supplementation on Diabetes Mangement
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2022 (Anticipated)
Primary Completion Date
February 1, 2023 (Anticipated)
Study Completion Date
February 10, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Nutrition and Food Technology Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In this randomized clinical trial, patients with diabetes will be randomly assigned to receive either Berberine, and Cinnamon supplements or placebo for 12 weeks. Then the glycemic characteristics will be compared in two groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes
Keywords
Diabetes, Berberine, Cinnamon
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Berberine+Cinnamon
Intervention Description
The supplements contains 400 mg Berberine, and 200 mg Cinnamon extract, and trace amounts of vitamins and minerals
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo contains Maltodexterin
Primary Outcome Measure Information:
Title
HbA1C
Description
HbA1C change from baseline
Time Frame
12th week
Secondary Outcome Measure Information:
Title
Fasting blood sugar
Description
Blood sugar change from baseline
Time Frame
12th week
Title
blood Insulin
Description
insulin change from baseline
Time Frame
12th week
Title
Lipid profile
Description
lipid profiles change from baseline
Time Frame
12th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 20-65 years
Diagnosed type-2 diabetes mellitus during the last 1 years
Currently only taking oral antidiabetic agents for the last 3 months
HbA1c 6.5-8.0%
Exclusion Criteria:
Patients with an allergy to berberine /cinamon
Patients using insulin therapy
Patients with raised baseline serum creatinine level (>1.5 mg/dl in men or > 1.2 mg/dl in women)
Lactation, pregnancy
Patients with any malignancy
Patients with unrelated chronic illness
Patients with cardiac, liver or respiratory failure
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Azita Hekmatdoost, MD, PhD
Phone
+98-22376470
Ext
300
Email
a_hekmat2000@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Berberine and Cinnamon in Management of Diabetes
We'll reach out to this number within 24 hrs