Hypertension Study

high blood pressure/ black seed oil

What is it? An investigative hypertension study using black seed oil.

Who can participate? Anyone 18-65 years old, with blood pressure between 135/85 -159/99.

 

Any compensation? Participants will be able to keep their digital blood pressure cuffs and will be paid $200 after study completion (after 3rd office visit). 

 

How long is the study? It is a total of 14 weeks. Two sets of 6-week treatments interrupted by a 2-week "washout" period.


What will be taken?

  • Each participant receives 12-weeks worth product (active and inactive).

  • The active product is a non-GMO cold press black seed  (Nigella sativa) oil.

  • The black seed oil is standardized to 3% thymoquinone (superior to any other oil on the market). 

  • Cold-press extracted black seed oil does not use of solvents or heat that can diminish the quality of the oil.

 
What will I need to do?
  • Take a supplement daily for a total of 12 weeks. There is a two week washout period between each 6-week treatment period.
  • Take daily blood pressures (a digital blood pressure cuff provided) and record them in a blood pressure journal. 
  • Attend 3 office visits/ orientations at the Natural Medicine of Stillwater, which includes a brief physical exam and questionnaire.
What dates and times are available for study office visits?

Orientation/ Start

  • Thursday May 2nd 5-7pm

  • Saturday May 4th 10am-12pm

  • Friday May 10th 10am 12pm


Mid-Study Follow Up

  • Thursday June 13th 5-7pm

  • Saturday June 15th 10am-12pm

  • Friday June 21st 10am 12pm


Study Conclusion/ Payment

  • Thursday July 25th 5-7pm

  • Saturday July 27th 10am-12pm

  • Friday August 2nd 10am 12pm

Accommodations can be made, on a case-by-case basis, if you are unable to make these scheduled office visit times, are traveling during one or more of these dates or become ill or are unable to meet a scheduled office visit. 
Contact Us to Learn More
651-342-1043 or email

Black Seed Oil

Introduction:

Nigella sativa (N. sativa) is a plant native to, and cultivated in, North Africa, Turkey, and the Middle East has been used throughout the world medicinally and as a food seasoning for centuries. Nigella sativa, commonly known as Black Seed. It is widely used in various traditional systems of medicine such as Ayurveda, Unani, and Siddha. The seeds of N. sativa are employed as a therapeutic tool for many different ailments and conditions. N. sativa has been shown to have antihypertensive, antimicrobial, immunomodulatory, diuretic, digestive, analgesic, antimicrobial, hypoglycemic, antioxidant, anti-inflammatory, anticancer, and antihistaminic properties, among others. Extensive preclinical, animal, and clinical research has been conducted on N. sativa’s properties. Due to its multitude of potential applications, N. sativa is among the top-ranked, evidence-based herbal medicines. Research has also revealed that most of the therapeutic properties of this plant are attributed to its essential oil constituent, thymoquinone. This paper endeavors to provide a detailed report on the characteristics, historical and modern uses, chemical composition, benefits of standardization, pharmacological activities, safety, toxicology, and recommended dosages of Nigella sativa.

Historical Uses:

Sources report Nigella sativa seeds have been used medicinally in the Middle East and Southeast Asia for over 2,000 years.  Black cumin seeds are mentioned in the Bible as well as in the Koran. People think of N. sativa as a holy plant created by God in order to relieve difficult medical conditions and in Arabic it used to be called “the blessing seed.” Greek pharmaco-botanist, Dioscorides (40-90 CE) described the use of black seeds from a plant now thought to be N. sativa as a remedy for breathing difficulties, inflammatory conditions, skin ailments, and parasites.Nigella seeds were also historically thought to be useful for the afterlife journey and were found in the tomb of Egyptian Pharaohs.

Where Ayurvedic Medicine is accepted and utilized, Nigella seed is commonly found in preparations used as remedies for abdominal bloating, gas, diarrhea, and intestinal worm infestations. In the Unani system of medicine practiced in India, Pakistan, Bangladesh, Malaysia, and Sri Lanka, dried Nigella seed (kalonji) is used for gastrointestinal conditions, asthma, headache and migraine, joint and low-back pain, nerve paralysis (hemiplegia, Bell’s palsy), jaundice, vitiligo, and other skin conditions. In the United States, the Food and Drug Administration (FDA) granted Nigella sativa Generally Recognized as Safe (GRAS) status for use as a spice, seasoning, or flavoring, Nigella sativa cold press oil has been used in the US and European markets for the last 30 years.

Current Uses and Research:

Preclinical, animal, and clinical research has demonstrated N. sativa’s beneficial effects on inflammation, microbial infections, respiratory conditions and allergies, immune function, blood pressure and cardiovascular function, blood sugar modulation, liver function, wound healing, some aspects of cancer, among others. There are approximately over 30 clinical trials evaluating the efficacy of Nigella seed preparations for a variety of conditions in humans including arthritis, cardiovascular conditions, diabetes, metabolic syndrome and obesity, respiratory conditions, and skin or cosmetic applications. Other research has investigated its use in humans for gastrointestinal conditions, seizures, mood and cognitive function, Hepatitis C, male infertility, cyclical breast pain, thyroid conditions, and liver function. Also noteworthy is the important and ongoing preclinical research investigating the effects of N. sativa’s thymoquinone constituent in various human carcinoma cell lines and animal cancer models, which will be discussed below.

Black Seed Oil:

The oil and the seed constituents of N. sativa, but primarily thymoquinone (TQ), exhibit potent anti-inflammatory effects in several inflammation-based models. Via suppression of the inflammatory mediators, prostaglandins, and leukotrienes, N. sativa extracts have demonstrated inflammation-modulating properties in experimental encephalomyelitis, colitis, peritonitis, edema, and arthritis. Research has shown that 0.45 mg Nigella seed oil (3% TQ) has been shown in an in vitro model to inhibit NO production by LPS-stimulated macrophages to a degree equivalent to 1 mg Curcumin C3, and also has been shown to potentiate the anti-inflammatory capacity of omega-3 oils. Raw oil and the TQ constituent have been shown to augment T-cell and natural killer cell-mediated immune responses, demonstrating thymoquinone’s beneficial immunomodulatory and respiratory stimulating properties. In addition, both the oil and its active ingredients expressed antimicrobial activity toward a variety of microbes and inhibitory properties toward certain types of cancer. N. sativa’s and TQ’s cardiovascular benefits have been demonstrated in both preclinical studies and clinical trials. There are a number of mechanisms behind its beneficial cardiovascular effects.

 

TQ appears to modulate inflammation and oxidative stress, improve vascular contractile responsiveness, modulate lipid profiles, modulate blood pressure, and inhibit prothrombotic events. Research has also demonstrated N. sativa constituents inhibit gluconeogenesis, regulate liver enzyme activity associated with glucose metabolism, preserve and improve proliferation of pancreatic beta cells, and prevent oxidative stress in both clinical trials and experimental models of hyperglycemia and diabetes. Other mechanisms of action attributed to N. sativa constituents are neuroprotective activity via opioid receptor stimulation and reduction of neuronal degeneration by TQ, hepatoprotective and nephroprotective activity via the antioxidant effects of thymoquinone and wound-healing activity via enhanced fibroblast proliferation and promotion of beta-fibroblast growth factor. Numerous preclinical and clinical trials demonstrate these beneficial effects and underscore Nigella sativa constituents’ multitude of potential therapeutic applications. Many studies confirm the pharmacological efficacy of Nigella sativa seed constituents, however, as a complex botanical containing more than 100 compounds, many of which have not yet been identified or studied, there is still much work to be done to reveal this plant’s full potential.

Safety:  

Nigella sativa has an excellent safety profile. When taken by mouth in food or in therapeutic amounts for short-term, Nigella sativa cold press oil has a history of safe consumption for the past 30 years. Studies in humans indicate a lack of significant adverse effects at oral dosages of 500 mg to 3 grams or 5mL daily. Human studies using more than 3 grams daily are not available, so safety at higher levels is unknown. N. sativa is also safe in children when given at lower doses.Data in pregnant women is not available, but consuming Nigella sativa as a seed on food is thought to be safe.

Side Effects:  

In clinical trials, higher doses of Nigella seed (>40 mg/kg body weight) have occasionally been associated with unspecified gastrointestinal complaints including constipation, burning sensation, vomiting, or mild nausea.

 

The following data will be collected:

  • Patient Demographics: age, sex, weight, and height

  • Daily resting (after sitting for 5-minutes) blood pressures; with provided digital blood pressure cuff.

  • MSQ-Medical Symptom/ Toxicity Questionnaire (performed in-office three times)

 

Inclusion criteria:  

  1. Subjects may be male or female, but must be between 18 and 65 years of age.

  2. Resting blood pressure between SBP 135-159/ DBP 85-99

  3. Female subjects must be non-pregnant and non-lactating.  If female subjects are of childbearing age, they may be included only if they are using reliable contraceptive measures and conduct a provided pregnancy test during office visit. 

  4. Participants must be able to understand the nature of the study and have signed consent form.

Exclusion Criteria:

  1. Any individual not meeting the inclusion criteria is excluded.

  2. Women who are pregnant or nursing.

  3. Non-pregnant women of childbearing potential who are not using reliable contraceptive measures (diaphragm, pill or IUD) on a regular basis.

  4. Subjects with congestive heart failure, resting bradycardia of 60 beats per minute or less (unless related to exercise, e.g., jogging).

  5. Subjects with severe neurological or cerebral dysfunction.

  6. Subjects who are participating in another clinical study of an investigative drug or who have participated in any clinical investigation within the past 30 days.

  7. Any subject considered not to be reliable based on the investigator interview in terms of taking medication as instructed, adherence to keeping scheduled appointments and other aspects of the protocol.

Study Procedures: If you agree to be in this study, we would ask you to do the following:

  • Schedule 3 visits to clinic (Orientation/ Start, Mid-Study Follow up and Study Conclusion/ Payment).

  • Take daily resting blood pressures (after 5-minutes sitting) daily for 14 weeks.

  • Complete daily blood pressure journals and return them at the 2nd and 3rd clinic visits. ​

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