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NCT05570357 | Not yet recruiting | Diabetes


Berberine and Cinnamon in Management of Diabetes
Sponsor:

National Nutrition and Food Technology Institute

Information provided by (Responsible Party):

Dr Azita Hekmatdoost

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.

Condition or disease

Diabetes

Intervention/treatment

Berberine+Cinnamon

Placebo

Phase

Phase 2

Phase 3

Study Type : Interventional
Estimated Enrollment : 42 participants
Masking : Triple
Primary Purpose : Treatment
Official Title : The Effects of Berberine and Cinnamon Supplementation on Diabetes Management
Actual Study Start Date : November 1, 2022
Estimated Primary Completion Date : February 1, 2023
Estimated Study Completion Date : February 10, 2023
Arm Intervention/treatment

Active Comparator: Intervention

Dietary Supplement: Berberine+Cinnamon

Placebo Comparator: Placebo

Other: Placebo

Ages Eligible for Study: 20 Years to 65 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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

Berberine and Cinnamon in Management of Diabetes

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Berberine and Cinnamon in Management of Diabetes

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