Berberine and Cinnamon in Management of Diabetes | NCT05570357

Studies
Berberine and Cinnamon in Management of Diabetes

NCT05570357

Sponsor

National Nutrition and Food Technology Institute

Status

Completed

Last Update Posted

Jun 11, 2024Actual

Enrollment

44Actual

Phase

Not Applicable

Conditions

Diabetes

Interventions

Berberine+Cinnamon (TDS)
Placebo (TDS)

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2022Actual

Primary Completion Date

Jan 1, 2023Actual

Completion Date

Feb 10, 2023Actual

First Submitted Date

Oct 2, 2022

First Submission Date that Met QC Criteria

Oct 5, 2022

First Posted Date

Oct 6, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 9, 2024

Last Update Posted Date

Jun 11, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr Azita Hekmatdoost, Prof., National Nutrition and Food Technology InstitutePrincipal Investigator

Lead Sponsor

National Nutrition and Food Technology InstituteOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Active Comparator		Dietary Supplement: Berberine+Cinnamon (TDS)
Placebo	Placebo Comparator		Other: Placebo (TDS)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Berberine+Cinnamon (TDS)	Dietary Supplement	The supplements contains 400 mg Berberine, and 200 mg Cinnamon extract	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HbA1C	HbA1C change from baseline	0 and 12th week

Secondary Outcomes

Measure	Description	Time Frame
Fasting blood sugar	Blood sugar change from baseline	0 and 12th week
Lipid profile	lipid profiles change from baseline	0 and 12th week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Azita Hekmatdoost		Tehran	Middle East	19835	Iran

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C076628	tyramine-deoxysorbitol

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided