Antidiabetic Potiential of Moringa and Dom Extract | NCT05898750

Studies
Antidiabetic Potiential of Moringa and Dom Extract

NCT05898750

Sponsor

Deraya University

Status

Completed

Last Update Posted

Sep 26, 2023Actual

Enrollment

25Actual

Phase

Early Phase 1

Conditions

Diabetes

Interventions

MorDom

Countries

Egypt

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

Sep 2023

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

Apr 22, 2023Actual

Primary Completion Date

Jun 22, 2023Actual

Completion Date

Jun 30, 2023Actual

First Submitted Date

May 22, 2023

First Submission Date that Met QC Criteria

Jun 1, 2023

First Posted Date

Jun 12, 2023Actual

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

Sep 24, 2023

Last Update Posted Date

Sep 26, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

The Antidiabetic potential of Hyphaene thebaica fruits and Moringa oleifera leaves will be investigated in diabetic patients (type 2). The patients will be maintained on tea of both drugs for 6 weeks. The fasting blood glucose levels of patients will be checked on a daily basis. Other blood biomarkers will be also reported such as insulin concentration, Lipid profile, liver enzymes, c-peptide and glycated hemoglobin

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

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
experimental group	Experimental		Dietary Supplement: MorDom
Control group	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MorDom	Dietary Supplement	oral powder in tea bags contains 4gm twice daily (equal concentration of each drugs)	experimental group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood glucose level	measured by fast blood test	3 months

Secondary Outcomes

Measure	Description	Time Frame
blood level of lipid profile	Blood samples were drawn to measure levels of LDL, HDL, triglycerides, total cholesterol	two weeks
Liver enzymes	Blood samples were drawn to measure levels of ALT and AST

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

diabetic patients type 2

Exclusion Criteria:

liver failure
heart failure
renal failure

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Soad A. Mohamad		Minya		05673	Egypt

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

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Browse Branches

Not provided