Effect Of Nigella Sativa Oil for the Treatment of Hypertension

My research explores the antihypertensive effects of Nigella sativa (black seed) oil in managing high blood pressure. Hypertension is a growing global health concern, often insufficiently controlled by standard medications. Nigella sativa, known for its bioactive compound thymoquinone, possesses antioxidant, anti-inflammatory, and vasodilatory properties, making it a potential natural remedy for blood pressure regulation.

Study Overview

• Status: Active, not recruiting
• Conditions: Hypertension
• Intervention / Treatment: Combination product: Nigella sativa (black seed)

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan
      • Bahria Town

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 30 to 70 years
• Diagnosed with mild to moderate hypertension (BP ≥140/90 mmHg)
• Willing to participate and provide written informed consent
• Not currently on any herbal or nutritional supplements

Exclusion Criteria:

• History of smoking or alcohol consumption
• Pregnant, postmenopausal, or breastfeeding women
• Use of dietary supplements or medications containing antioxidants, caffeine, estrogen, or steroids
• Individuals engaging in regular vigorous physical exercise
• Those adding extra salt to their meals
• Known allergy to Nigella sativa or black seed oil

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nigella sativa Oil Supplementation	Combination product: Nigella sativa (black seed); Participants in Group 1 (intervention group) will receive Nigella sativa (black seed) oil at a dosage of 0.5 ml, administered orally twice daily-once before breakfast and once before bedtime-for a duration of 12 weeks. The oil, sourced from a standardized local supplier, is rich in thymoquinone, known for its antioxidant and vasodilatory properties. Blood pressure will be measured at baseline and biweekly intervals using a calibrated digital sphygmomanometer to monitor changes in systolic and diastolic values. Participants will also be monitored regularly for any adverse effects.
No Intervention: No Intervention (Control Group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Structured Patient History Questionnaire	A pre-designed, structured questionnaire will be used at baseline to collect demographic information, medical history, medication use, dietary habits, and lifestyle factors. This is a qualitative tool without a scoring system but is essential for eligibility confirmation and contextual analysis	12 Months

Collaborators and Investigators

• Sponsor: Superior University

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2022
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: June 28, 2025
• First Submitted That Met QC Criteria: July 8, 2025
• First Posted (Actual): July 9, 2025

Study Record Updates

• Last Update Posted (Actual): July 9, 2025
• Last Update Submitted That Met QC Criteria: July 8, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: MSAHSW/Batch-Fall23/924

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No