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Study aim
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Evaluation of the effect of Ajwain extract as an add-on therapy on blood pressure control, lipid profile, and fasting blood sugar in patients with hypertension
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Design
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A controlled, parallel-group, double-blind, randomized clinical trial on 80 patients. Individual block randomization and computer statistical software were used for randomization.
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Settings and conduct
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Eligible patients will be individually allocated to the two groups using individual block randomization and statistical software. To maintain blinding, the capsules for both groups are completely identical in appearance and labeled with anonymous codes, and the participants, caregivers, researchers, assessors are kept blind to the patients' group allocation. The study location is the Cardiology Clinic of Afshar Hospital in Yazd.
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Participants/Inclusion and exclusion criteria
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Participants:
Patients with hypertension referred to the cardiology clinic of Afshar Hospital in Yazd.
Inclusion Criteria:
Diagnosis of Hypertension; Use of Antihypertensive Medication; Informed Consent and Protocol Adherence
Exclusion Criteria:
Pregnancy or Lactation; Specific Diseases; Acute Infectious or Inflammatory Diseases; History of Allergy to Ajwain; History of Severe Drug Side Effects; Consumption of Alcohol; Use of Calcium Channel Blockers
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Intervention groups
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In this study, two parallel intervention groups will participate.
The active intervention group will receive a capsule containing 250 mg of standardized Ajwain Extract orally, twice a day, for 8 consecutive weeks.
In contrast, the control group will also consume a placebo capsule containing edible starch powder, with the same dose and in the same manner. The placebo capsules have been prepared to be visually completely similar to the Ajwain extract to fully maintain the blinding principle.
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Main outcome variables
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Change in mean systolic blood pressure; change in mean diastolic blood pressure