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 |
| Secondary identifying numbers | N/A |
- 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
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
| Study design | Single-centre, interventional, randomised double-blind placebo-controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Pycnogenol® |
| Primary outcome measure | 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 |
| Secondary outcome measures | 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 |
| Overall study start date | 01/08/2003 |
| Completion date | 01/08/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
85724-5155
United States of America
Sponsor information
Horphag Research Ltd (Switzerland)
Industry
Industry
P.O. Box 80
Avenue Louis-Casai 71
Cointrin
Geneva
CH-1216
Switzerland
| Website | http://www.horphag.com |
|---|---|
"ROR" |
https://ror.org/003n34405 |
Funders
Funder type
Industry
Horphag Research Ltd (Switzerland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
