Trials Sponsors Conditions Drugs Pricing

Conditions

Cardiac Autonomic Neuropathy Type 2 Diabetes

Keywords

Cardiac Autonomic Neuropathy

Outcome Measures

Primary Outcomes (1)

Primary Efficacy of α-lipoic Acid in patients with cardiac autonomic neuropathy
check the Heart rate variability(HRV) Index
up to 24weeks

Secondary Outcomes (1)

Secondary Efficacy of α-lipoic Acid in patients with cardiac autonomic neuropathy
up to 24weeks

Other Outcomes (1)

Number of Patients with Adverse events as a Measure of Safety
up to 24weeks

Study Arms (2)

α-lipoic acid

ACTIVE COMPARATOR

α-lipoic acid PO medication, 600mg per day, for 6weeks α-lipoic acid PO medication, 1200mg per day, for 6weeks

Drug: α-lipoic acid

No treatment group

NO INTERVENTION

No Intervention

Interventions

α-lipoic acidDrug

α-lipoic acid 600mg PO medication,Per day, For 6weeks α-lipoic acid 1200mg PO medication,Per day, For 6weeks

Also known as: Neuropaid OD Tablet

α-lipoic acid

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

Eligibility Criteria

Age20 Years - 80 Years

Sexall

Healthy VolunteersNo

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

You may qualify if:

Established Cardiac Autonomic Neuropathy in type 2 diabetes.
aged 20 years to 80 years

Sponsors & Collaborators

The Catholic University of Korea
Otherlead

Study Sites (3)

The Catholic University of Korea

Seoul, Seoul, 137-701, South Korea

Eulji General Hospital

Seoul, Seoul, South Korea

Sejong General Hospital

Seoul, Seoul, South Korea

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Thioctic Acid

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Carboxylic AcidsOrganic ChemicalsThiophenesSulfur CompoundsCoenzymes

Study Officials

Bong Yun Cha, MD, PhD
The Catholic University of Korea
PRINCIPAL INVESTIGATOR

Enrollment

91 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor

Study Record Dates

First Submitted

February 3, 2014

First Posted

February 6, 2014

Study Start

January 2010

Date type not reported

This date has not been verified as actual or estimated.

The Effect of α-lipoic Acid Treatment in Patient With Cardiac Autonomic Neuropathy

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (1)

Study Arms (2)

α-lipoic acid

No treatment group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention 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

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (1)

Study Arms (2)

α-lipoic acid

No treatment group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations