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Pilot Study of Vedic Medicine for Type 2 Diabetes

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Vedic Medicine

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus Type 2, Vedic medicine, Ayurveda, Transcendental Meditation

Eligibility Criteria

25 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Kaiser Permanente Center for Health Research

Outcomes

Primary Outcome Measures

HbA1C

Secondary Outcome Measures

Fasting Glucose

Lipids

Full Information

NCT ID

NCT00065650

First Posted

July 30, 2003

Last Updated

April 14, 2015

Sponsor

National Center for Complementary and Integrative Health (NCCIH)

1. Study Identification

Unique Protocol Identification Number

NCT00065650

Brief Title

Pilot Study of Vedic Medicine for Type 2 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

July 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

January 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus Type 2, Vedic medicine, Ayurveda, Transcendental Meditation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Vedic Medicine

Intervention Type

Behavioral

Intervention Name(s)

Vedic Medicine

Primary Outcome Measure Information:

Title

HbA1C

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Fasting Glucose

Time Frame

3 and 6 months

Title

Lipids

Time Frame

3 and 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Facility Information:

Facility Name

Kaiser Permanente Center for Health Research

City

Portland

State/Province

Oregon

ZIP/Postal Code

97227

Country

United States

12. IPD Sharing Statement

Citations:

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.

Results Reference

background

Citation

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

Results Reference

background

PubMed Identifier

17017752

Citation

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.

Results Reference

result

Links:

URL

http://www.kpchr.org/public/default.asp

Description

Kaiser Permanente Center for Health Research External Site

Learn more about this trial

Pilot Study of Vedic Medicine for Type 2 Diabetes

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