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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
  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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 22, 2014