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The Effects of the Onion-Pumpkin Extract on Blood Pressure

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ClinicalTrials.gov Identifier: NCT02353104
Recruitment Status : Completed
First Posted : February 2, 2015
Last Update Posted : February 2, 2015
Sponsor:
Information provided by (Responsible Party):
Medicus Research, LLC

Brief Summary:
This open-label, adaptive-design, pilot study was designed to evaluate the effect of Onion-Pumpkin Extract in supporting healthy blood pressure as assessed by the change in systolic and diastolic blood pressures. The effect of the product on glucose metabolism, lipid levels, and antioxidant levels would also be determined. Tolerability and safety of the study product would also be investigated.

Condition or disease Intervention/treatment Phase
Blood Pressure Dietary Supplement: Onion-Pumpkin Extract Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effects of the Onion-Pumpkin Extract on Blood Pressure: An Open-label, Adaptive-design, Pilot Study
Study Start Date : November 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Arm Intervention/treatment
Experimental: Onion-Pumpkin Extract
Take two capsules, twice daily before breakfast and dinner
Dietary Supplement: Onion-Pumpkin Extract



Primary Outcome Measures :
  1. Systolic Blood Pressure [ Time Frame: 12 weeks ]
    Change in Individual SBP Values

  2. Systolic Blood Pressure (Change in Mean SBP Values) [ Time Frame: 12 weeks ]
    Change in Mean SBP Values

  3. Diastolic Blood Pressure (Change in Individual DBP Values) [ Time Frame: 12 weeks ]
    Change in Individual DBP Values

  4. Diastolic Blood Pressure (Change in Mean DBP Values) [ Time Frame: 12 weeks ]
    Change in Mean DBP Values


Secondary Outcome Measures :
  1. Change in complete blood cell count (CBC) [ Time Frame: 12 weeks ]
  2. Change in Comprehensive Metabolic Panel (CMP) [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI ≥ 25 and ≤ 35 kg/m2
  • Blood pressure:

    • SBP: 140-160 mmHg
    • DBP: 80-90 mmHg
  • Judged by the Investigator to be in general good health on the basis of medical history
  • Females of child bearing potential must agree to use appropriate birth control methods during the entire study period.
  • Understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator.

Exclusion Criteria:

  • Subjects currently taking any antihypertensive medications
  • Subjects taking prescription blood pressure, cholesterol and/or diabetes medication.
  • Subjects currently taking dietary supplements or over the counter medication. (2 week washout allowed)
  • History or presence of cancer in the prior two years.
  • Recent history of (within 12 months) or strong potential for alcohol or substance abuse.
  • Current tobacco smokers
  • Participation in a clinical study with exposure to any non-registered drug product within 30 days prior.
  • Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk

    • Including subjects who are Bed or wheelchair-bound
  • Clinically significant abnormal Physical Examination.
  • Central Neurological disorders including but not limited to Spinal cord injuries, multiple sclerosis, and Parkinson disease.
  • Pregnant, lactating, or unwilling to use adequate contraception during the duration of the study.
  • Any other condition that, in the opinion of the investigator, would adversely affect the subject's ability to complete the study or its measures.
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Responsible Party: Medicus Research, LLC
ClinicalTrials.gov Identifier: NCT02353104    
Other Study ID Numbers: HORN1000
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: February 2, 2015
Last Verified: January 2015