NCT00065650CompletedPhase 2
Pilot Study of Vedic Medicine for Type 2 Diabetes
National Center for Complementary and Integrative Health (NCCIH)1 site in 1 country60 target enrollmentStarted: July 1, 2003Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- HbA1C
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
HbA1C
Time Frame: 3 months
Secondary Outcomes
- Lipids(3 and 6 months)
- Fasting Glucose(3 and 6 months)
Investigators
Study Sites (1)
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