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NCT00065650 Clinical Trial

Pilot Study of Vedic Medicine for Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00065650
Other study ID # R21AT001324-01
Secondary ID
Status Completed
Phase Phase 2
First received July 30, 2003
Last updated April 14, 2015
Start date July 2003
Est. completion date January 2004

Study information
Verified date April 2015
Source National Center for Complementary and Integrative Health (NCCIH)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date January 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 25 Years to 80 Years
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Vedic Medicine

Behavioral:
• Vedic Medicine

Locations
Country Name City State
United States Kaiser Permanente Center for Health Research Portland Oregon

Sponsors (1)
Lead Sponsor Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Elder C, Aickin M, Bauer V, Cairns J, Vuckovic N. Randomized trial of a whole-system ayurvedic protocol for type 2 diabetes. Altern Ther Health Med. 2006 Sep-Oct;12(5):24-30. — View Citation

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

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1C 3 months No
Secondary Fasting Glucose 3 and 6 months
Secondary Lipids 3 and 6 months
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