NCT05570357

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable diabetes

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 6, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2023

Completed
Last Updated

June 11, 2024

Status Verified

June 1, 2024

Enrollment Period

6 months

First QC Date

October 2, 2022

Last Update Submit

June 9, 2024

Conditions

Diabetes

Keywords

DiabetesBerberineCinnamon

Outcome Measures

Primary Outcomes (1)

  • HbA1C

    HbA1C change from baseline

    0 and 12th week

Secondary Outcomes (5)

  • Fasting blood sugar

    0 and 12th week

  • Lipid profile

    0 and 12th week

  • Anthropometric measurements

    0 and 12th week

  • Blood Pressure

    0 and 12th week

  • CRP

    0 and 12th week

Study Arms (2)

Intervention

ACTIVE COMPARATOR
Dietary Supplement: Berberine+Cinnamon (TDS)

Placebo

PLACEBO COMPARATOR
Other: Placebo (TDS)

Interventions

Berberine+Cinnamon (TDS)DIETARY_SUPPLEMENT

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

Intervention
Placebo (TDS)OTHER

Placebo contains Maltodexterin

Placebo

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azita Hekmatdoost

Tehran, Middle East, 19835, Iran

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

tyramine-deoxysorbitol

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

October 2, 2022

First Posted

October 6, 2022

Study Start

July 1, 2022

Primary Completion

January 1, 2023

Study Completion

February 10, 2023

Last Updated

June 11, 2024

Record last verified: 2024-06

Locations

IR(1)