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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
National Nutrition and Food Technology Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes focused on measuring Diabetes, Berberine, Cinnamon

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 2, 2022
    Last Updated
    October 5, 2022
    Sponsor
    National Nutrition and Food Technology Institute
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    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

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    Berberine and Cinnamon in Management of Diabetes

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