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Safety evaluation and biochemical efficacy of celery seed extract (Apium Graveolens) capsules in hypertensive patients: a randomized, triple-blind, placebo-controlled, cross-over, clinical trial

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Abstract

The present study was conducted to evaluate the safety of celery seed extract (Apium graveolens), as a medicinal herb with active ingredients such as 3-n-butylphthalide (NBP), in hypertensive patients. This study was a randomized, triple-blind, placebo-controlled, cross-over clinical trial. Hypertensive patients (51 participants) received 4 celery seed capsules (a total of 1.34 g extract per day) or 4 placebo capsules per day for 4 weeks as a supplement to their usual medication regimen. The results indicated that the celery seed capsule not only was safe for hypertensive patients but also caused a reduction in BP, FBS, and lipid profile values. Also, it had beneficial effects on kidney and liver functions. No significant change was observed in blood cells and serum electrolytes (p > 0.05). The mean reduction in BUN and SCr were 3.43 and 0.075 mg/dL, and in SGPT and SGOT were 4.08 and 3.03 U/L, respectively (p < 0.05). FBS reduced from 108.53 to 97.96 mg/dL after 4 weeks of celery administration (p < 0.01). The decrease in TC, TG, LDL, and increase in HDL were 16.37, 16.22, 11.84, and 2.52 mg/dL, respectively (p < 0.001). According to the promising results of this clinical trial, celery seed extract can be considered a safe supplement for hypertensive patients. The study is limited by the small sample size; therefore, larger randomized trials are required.

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Availability of data and materials

The data that support the findings of this study are available on request from the corresponding author.

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Abbreviations

ABPM:

24 H Ambulatory blood pressure monitoring

ALP:

Alkaline phosphatase

BMI:

Body mass index

BUN:

Blood urea nitrogen

CBC:

Complete blood count

DBP:

Diastolic blood pressure

FBS:

Fasting blood sugar

GCP:

Good clinical practice

Hb:

Hemoglobin

LDL:

Low-density lipoprotein

Lymph:

Lymphocyte number

HDL:

High-density lipoprotein

MAP:

Mean arterial blood pressure

MCHC:

Mean cell hemoglobin concentration

MCV:

Mean cell volume

NBP:

3-N-butylphthalide

PCV:

Packed cell volume

PLT:

Platelet count

PP:

Pulse pressure

RBC:

Red blood cell count

RO:

Reactive oxygen species

SBP:

Systolic blood pressure

SCr:

Serum creatinine

SGOT or AST:

Serum glutamic oxaloacetic transaminase

SGPT or ALT:

Serum glutamic pyruvic transaminase

TC:

Total cholesterol

TG:

Triglyceride

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Acknowledgements

The authors would like to gratefully acknowledge the Vice Chancellor for Research at Mashhad University of Medical Sciences for financial support. This article is a part of the results of the Ph.D. dissertation, Grant number 941237 registered in the Mashhad University of Medical Sciences, Mashhad, Iran. They would also like to gratefully thank Mr. Seyed Sadegh Assaran for his participation in blood sampling from patients in Ghaem Hospital.

Funding

Mashhad University of Medical Sciences, Grant number 941237, Seyed Ahmad Mohajeri.

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Authors

Contributions

MSR: conceptualization; data curation; data analysis; investigation; methodology; software; validation; visualization; writing—original draft; writing—review and editing. MM: conceptualization; data curation; project administration; validation; visualization. SME: statistical analysis. VSM: HPLC analysis. SAM: conceptualization; data curation; funding acquisition; methodology; project administration; supervision; resources; validation; writing—review and editing.

Corresponding author

Correspondence to Seyed Ahmad Mohajeri.

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Conflict of interest

We declare there is no conflict of interest related to this study and there was no financial support that influence its outcome.

Ethics approval

The study is in compliance with the regulations of Iran and approved by an independent ethics committee of Mashhad University of Medical Sciences, Mashhad, Iran (ethics committee reference number and approval date: IR.MUMS.REC.1394.705, 2016-02-27).

Consent to participate

Details and procedures of the study were completely explained to patients through an interview, consent to participate was obtained before the start of study treatment.

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Consent for publication gives my consent for the publication of identifiable details, which can include details within the text to be published in Inflammopharmacology.

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Shayani Rad, M., Moohebati, M., MohammadEbrahimi, S. et al. Safety evaluation and biochemical efficacy of celery seed extract (Apium Graveolens) capsules in hypertensive patients: a randomized, triple-blind, placebo-controlled, cross-over, clinical trial. Inflammopharmacol 30, 1669–1684 (2022). https://doi.org/10.1007/s10787-022-00986-0

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