NCT00065650

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_2 diabetes-mellitus-type-2

Timeline
Completed

Started Jul 2003

Shorter than P25 for phase_2 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 31, 2003

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2004

Completed
Last Updated

April 15, 2015

Status Verified

April 1, 2015

First QC Date

July 30, 2003

Last Update Submit

April 14, 2015

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus Type 2Vedic medicineAyurvedaTranscendental Meditation

Outcome Measures

Primary Outcomes (1)

  • HbA1C

    3 months

Secondary Outcomes (2)

  • Fasting Glucose

    3 and 6 months

  • Lipids

    3 and 6 months

Interventions

Vedic MedicineDRUG

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Kaiser Permanente members
  • Newly diagnosed type 2 Diabetes
  • Baseline glycosylated hemoglobin level of 6.0-7.9.

You may not qualify if:

  • Pregnancy or nursing mother
  • Currently taking warfarin
  • Diagnosis of psychotic disorder or recent hospitalization for depression
  • Unable to comply with or attend treatment sessions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227, United States

Location

Related Publications (3)

  • 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.

    BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 17017752RESULT

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

July 30, 2003

First Posted

July 31, 2003

Study Start

July 1, 2003

Study Completion

January 1, 2004

Last Updated

April 15, 2015

Record last verified: 2015-04

Locations

US(1)