Pilot Study of Vedic Medicine for Type 2 Diabetes

This study has been completed.

Sponsor:

Information provided by:

National Center for Complementary and Alternative Medicine (NCCAM)

ClinicalTrials.gov Identifier:

NCT00065650

First received: July 30, 2003

Last updated: June 23, 2005

Last verified: June 2005

History of Changes

Tracking Information
First Received Date ^ICMJE	July 30, 2003
Last Updated Date	June 23, 2005
Start Date ^ICMJE	July 2003
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00065650 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Pilot Study of Vedic Medicine for Type 2 Diabetes
Official Title ^ICMJE	Not Provided
Brief Summary	The purpose of this study is to determine the feasibility and effectiveness of a multimodality Vedic Medicine treatment protocol for the management of newly diagnosed type 2 diabetes.
Detailed Description	Maharishi Vedic Medicine (MVM) represents a synthesis of Vedic sciences, including Ayur-Veda, into a single, comprehensive, natural approach to health care. The objectives of this phase II pilot trial are to determine the feasibility, acceptability, and safety of implementing a multi-modality MVM intervention for newly diagnosed type 2 diabetics, and to measure the impact of such a protocol on overall glycemic control.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Diabetes Mellitus, Type 2
Intervention ^ICMJE	Drug: Vedic Medicine Behavioral: Vedic Medicine
Study Arm (s)	Not Provided
Publications *	Elder C. Application of the cooperative health care clinic model for the delivery of complementary/ alternative care. The Permanente Journal. Winter 2003; 7(1):55-60. Elder C. Complementary and Alternative Medicine Symposium: Integrating CAM into clinical practice: The KP northwest story. The Permanente Journal, Fall 2002, 6(4):57-59
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	60
Completion Date	January 2004
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion criteria: Kaiser Permanente members Newly diagnosed type 2 Diabetes Baseline glycosylated hemoglobin level of 6.0-7.9. Exclusion criteria: Pregnancy or nursing mother Currently taking warfarin Diagnosis of psychotic disorder or recent hospitalization for depression Unable to comply with or attend treatment sessions
Gender	Both
Ages	25 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00065650
Other Study ID Numbers ^ICMJE	R21 AT001324-01
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	National Center for Complementary and Alternative Medicine (NCCAM)
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	National Center for Complementary and Alternative Medicine (NCCAM)
Verification Date	June 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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