Ignite Creation Date:
2024-05-05 @ 11:16 PM
Last Modification Date:
2024-10-26 @ 10:31 AM
Study NCT ID:
NCT01296308
Status:
COMPLETED
Last Update Posted:
2012-07-17
First Post:
2011-02-14
Brief Title:
Complementary and Integrative Therapy for Diabetic Neuropathy
Sponsor:
Universität Duisburg-Essen
Organization:
Universität Duisburg-Essen
Study Overview
Official Title:
Effectiveness of a Complementary and Integrative Therapy in Diabetic Neuropathy Patients
Status:
COMPLETED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CIT-DN
Brief Summary:
Despite the long tradition of complementary and alternative medicine CAM therapies there are hardly any interventional trials on type 2 diabetes mellitus Hence this pilot study aims to investigate the influence of a two weeks integrative inpatient therapy on the quality of life in 50 patients suffering from diabetic neuropathy Integrative treatment includes aspects of conventional and traditional European and Chinese medicine mind-body medicine physical therapy and lifestyle modification nutrition advices stress management and exercise training The observational design intends four measurement points tree months before T0 directly before T1 directly after treatment T2 and three months follow-up T3 The subjective evaluation of the neuropathy-related quality of life was combined with neurophysiologic instruments QST to measure neuropathic symptoms Also pain intensity locus of control interpretation of illness coping style anxietydepression life satisfaction and several biomarkers HbA1c ABI WHR and BMI are measured In addition a qualitative interview should give a view to patient perspective of therapy process
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None