Naturopathic Treatment for the Prevention of Cardiovascular Disease (Cardio pilot)

The Canadian College of Naturopathic Medicine

Status and phase: Completed; Phase 3

Conditions: Cardiovascular Disease

Treatments: Other: Conventional medical treatment (Atorvastatin,Fluvastatin,Lovastatin,Pravastatin,Rosuvastatin,Simvastatin); Other: Naturopathic medicine. May include: fish oil, plant sterols, soluble fiber, cinnamon, coQ10 and exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT00718796

CP/CUPW4

Details and patient eligibility

About

This study is designed to test the ability of a comprehensive naturopathic approach to reduce important risk factors for the development of cardiovascular disease. Treatment will take place over the course of one year and the comparator/control group will be followed by their medical doctors and be given conventional care.

Full description

Interventions will consist of an individualized treatment approach guided by an expert panel of clinicians who treat patients with cardiovascular disease. These interventions will consist of a combination of dietary, lifestyle and specific recommendations for supplementation. As this is a pragmatic study, blinding will not be attempted nor is appropriate.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 to 65 years old
• CUPW worker
• prescreening indicates higher than normal TC/HDL ratio

Exclusion criteria

• Experienced an MI or stroke within past 6 months

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

300 participants in 2 patient groups

1

Experimental group

Description:

Individualized naturopathic treatment consisting of dietary and lifestyle advice and individualized supplementation

Treatment:

Other: Naturopathic medicine. May include: fish oil, plant sterols, soluble fiber, cinnamon, coQ10 and exercise

2

Active Comparator group

Description:

Current care control provided by participants' medical doctor

Treatment:

Other: Conventional medical treatment (Atorvastatin,Fluvastatin,Lovastatin,Pravastatin,Rosuvastatin,Simvastatin)