Trials Sponsors Conditions Drugs Pricing

Conditions

Type 2 Diabetes Mellitus

Keywords

DiabetesDiabetes MellitusHerbalfood supplement

Outcome Measures

Primary Outcomes (1)

Change in HbA1C concentrations and fasting glucose levels
6 months from last patient in

Study Arms (2)

DbXell

EXPERIMENTAL

Drug: DbXell three times daily for 12 weeks and then switching to Placebo of DbXell for 12 additional months Other: Lifestyle modification Each study subject will be provided with and instructed to follow a lifestyle modification (particularly regarding dietary advice and exercise) during the subject's participation in the study.

Dietary Supplement: DbXell

Placebo

PLACEBO COMPARATOR

Drug: Placebo of DbXell Placebo of DbXell three times daily for 12 weeks and then switching to DbXell for 12 additional weeks Other: Lifestyle modification Each study subject will be provided with and instructed to follow a lifestyle modification (particularly regarding dietary advice and exercise) during the subject's participation in the study.

Dietary Supplement: Placebo

Interventions

DbXellDietary supplement

DbXell

PlaceboDietary supplement

Placebo

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female subjects with age of 18-70 years Established type 2 diabetes mellitus as defined by the American Diabetes Association, but of duration less than 10 years.
Suboptimal glycemic control as judged by HbA1c over target but not more than 8.0%.Current medication of not more than 2 oral hypoglycemic agents. No current or past insulin or GLP1 therapy.

Sponsors & Collaborators

Laniado Hospital
Otherlead
KGS Research
Othercollaborator

Study Sites (1)

Laniado Hospital, Diabetes Unit

Netanya, 42150, Israel

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

Mark J Niven, MD
Laniado Hospital
PRINCIPAL INVESTIGATOR

Enrollment

20 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Dr Mark J NIVEN Director of Endocrine and Diabetes Unit

Study Record Dates

First Submitted

April 2, 2014

First Posted

April 28, 2014

Study Start

July 2014

Date type not reported

This date has not been verified as actual or estimated.

Role of DbXell in the Treatment of Subjects With Mildly Uncontrolled Type 2 Diabetes Mellitus

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

DbXell

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

DbXell

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations