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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
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

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

ClinicalTrials.gov Identifier: NCT00065650     History of Changes
Other Study ID Numbers: R21 AT001324-01
Study First Received: July 30, 2003
Last Updated: June 23, 2005
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:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013