NCT07055763

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Mar 2022

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 17, 2022

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 9, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

July 9, 2025

Status Verified

June 1, 2025

Enrollment Period

3.5 years

First QC Date

June 28, 2025

Last Update Submit

July 8, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Nigella sativa Oil Supplementation

EXPERIMENTAL
Combination Product: Nigella sativa (black seed)

No Intervention (Control Group)

NO INTERVENTION

Interventions

Nigella sativa (black seed)COMBINATION_PRODUCT

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.

Nigella sativa Oil Supplementation

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahria Town

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Hypertension

Interventions

Nigella sativa oil

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 28, 2025

First Posted

July 9, 2025

Study Start

March 17, 2022

Primary Completion

September 1, 2025

Study Completion

February 28, 2026

Last Updated

July 9, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations