Pilot Study of Vedic Medicine for Type 2 Diabetes - Tabular View

Tracking Information
First Received Date ^ICMJE	July 30, 2003
Last Updated Date	June 23, 2005
Start Date ^ICMJE	July 2003
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00065650 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Pilot Study of Vedic Medicine for Type 2 Diabetes
Official Title ^ICMJE
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 Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Diabetes Mellitus, Type 2
Intervention ^ICMJE	Drug: Vedic Medicine Behavioral: Vedic Medicine
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	60
Completion Date	January 2004
Primary Completion Date
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 ID ^ICMJE	NCT00065650
Responsible Party
Study ID Numbers ^ICMJE	R21 AT001324-01
Study Sponsor ^ICMJE	National Center for Complementary and Alternative Medicine (NCCAM)
Collaborators ^ICMJE
Investigators ^ICMJE
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