Pycnogenol® to reduce use of commercial anti-hypertensive medications: a randomised, double-blind, placebo-controlled, prospective, 15-week study

ISRCTN	ISRCTN44961472
DOI	https://doi.org/10.1186/ISRCTN44961472
Protocol serial number	N/A
Sponsor	Horphag Research Ltd (Switzerland)
Funder	Horphag Research Ltd (Switzerland)

Submission date: 18/10/2007
Registration date: 31/10/2007
Last edited: 31/10/2007

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Ronald Watson
Scientific

Mel and Enid Zuckerman College of Public Health
University of Arizona, Health Science Center
1295 N. Martin
P. O. Box 245155 [FedEx building 202 room 252]
Tucson
85724-5155
United States of America

Study information

Primary study design	Interventional
Study design	Single-centre, interventional, randomised double-blind placebo-controlled study
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Pycnogenol®, a natural product, a "complementary or alternative medicine", will reduce the use of antihypertensive medicines (Angiotensin Converting Enzyme [ACE] inhibitors) and Cardiovascular Disease (CVD) risk factors in subjects with both hypertension and type 2 diabetes.
Ethics approval(s)	Ethics approval received from the Human Subjects Protection Program at University of Arizona on the 16th August 2003 (ref: 03-129).
Health condition(s) or problem(s) studied	Cardiovascular risk factors in diabetes
Intervention	Oral administration of Pycnogenol® pills (25 mg, 5 times a day) or matched inactive placebo for 12 weeks. Total duration of follow-up is 15 weeks.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Pycnogenol®
Primary outcome measure(s)	Measured at 12th week of treatment: 1. Blood pressure, measured on the left arm after 10 minutes rest (Korotkoff sounds I and V were taken as the systolic and diastolic blood pressures) 2. Serum endothelin-1 3. Fasting Low Density Lipoprotein (LDL)-cholesterol 4. Glycosylated haemoglobin (HbA1c) 5. Fasting plasma glucose 6. Urinary albumin concentration
Key secondary outcome measure(s)	Measured at 4th and 8th week of treatment: 1. Blood pressure, measured on the left arm after 10 minutes rest (Korotkoff sounds I and V were taken as the systolic and diastolic blood pressures) 2. Serum endothelin-1 3. Fasting Low Density Lipoprotein (LDL)-cholesterol 4. Glycosylated haemoglobin (HbA1c) 5. Fasting plasma glucose 6. Urinary albumin concentration
Completion date	01/08/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	80
Key inclusion criteria	1. Men and women, 40 - 75 years of age 2. Non-insulin dependent type 2 diabetes 3. Receiving pharmaceutical treatment (ACE-inhibitors) for hypertension 4. Pre-trial systolic blood pressure of 130 - 150 mmHg
Key exclusion criteria	1. Type 1 diabetes 2. Use of insulin 3. Any supplements other than single daily multivitamin 4. Having any major illness such as cancer, asthma, or heart failure 5. Any previous cardiac events 6. Pregnancy, or being nursing mother
Date of first enrolment	01/08/2003
Date of final enrolment	01/08/2007

Locations

Countries of recruitment

United States of America

Study participating centre

Mel and Enid Zuckerman College of Public Health

Tucson
85724-5155
United States of America

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan