Pilot Study of Vedic Medicine for Type 2 Diabetes

This study has been completed.

First Received: July 30, 2003 Last Updated: June 23, 2005 History of Changes

Sponsor:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00065650

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: Vedic Medicine Behavioral: Vedic Medicine	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Estimated Enrollment:	60
Study Start Date:	July 2003
Estimated Study Completion Date:	January 2004

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.

Eligibility

Ages Eligible for Study:	25 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00065650

Locations

United States, Oregon
Kaiser Permanente Center for Health Research
Portland, Oregon, United States, 97227

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

More Information

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

Study ID Numbers:	R21 AT001324-01
Study First Received:	July 30, 2003
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00065650 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

Diabetes Mellitus Type 2
Vedic medicine
Ayurveda
Transcendental Meditation

Additional relevant MeSH terms:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on November 27, 2009