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OpenTrials
Completed

NCT Number: NCT05570357

Berberine and Cinnamon in Management of Diabetes

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.

Completed

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azita Hekmatdoost

Tehran, Middle East, 19835, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 30-70 years
  • Diagnosed type-2 diabetes mellitus (based on American Diabetes Association criteria)

Exclusion criteria

  • Patients with an allergy to berberine /cinamon
  • Lactation, pregnancy
  • Patients with any malignancy
  • Patients with unrelated chronic illness
  • Patients with cardiac, liver or respiratory failure

Treatment and study plan

Berberine+Cinnamon (TDS)

Dietary Supplement

The supplements contains 400 mg Berberine, and 200 mg Cinnamon extract

Placebo (TDS)

Other

Placebo contains Maltodexterin

Primary outcomes

  1. HbA1C

    Time frame: 0 and 12th week

    HbA1C change from baseline

Secondary outcomes

  1. Fasting blood sugar

    Time frame: 0 and 12th week

    Blood sugar change from baseline

  2. Lipid profile

    Time frame: 0 and 12th week

    lipid profiles change from baseline

  3. Anthropometric measurements

    Time frame: 0 and 12th week

    weight, height, BMI, WC

  4. Blood Pressure

    Time frame: 0 and 12th week

    measuring according to the BP measurement guideline

  5. CRP

    Time frame: 0 and 12th week

    measuring the blood concentration of C-reactive protein

Sponsors and collaborators

Lead sponsor

National Nutrition and Food Technology Institute

Other

Registry information

Official study title

The Effects of Berberine and Cinnamon Supplementation on Diabetes Mangement

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 6, 2022
Registry last updated
Jun 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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