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Diuretic Effect Evaluation of Petroselinum Crispum (Parsley) in Hypertensive Patients (DEEP)

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ClinicalTrials.gov Identifier: NCT03468361
Recruitment Status : Withdrawn (The hospitals could not enroll any patients. Therefore, the authors decided to withdraw the study.)
First Posted : March 16, 2018
Last Update Posted : March 25, 2020
Sponsor:
Collaborator:
Imam Abdulrahman Bin Faisal University
Information provided by (Responsible Party):
Atta Abbas Naqvi, Universiti Sains Malaysia

Brief Summary:

The use of alternative therapy, particularly herbal treatment is becoming prevalent among patients. Many herbs are in-use for various ailments such as diabetes, digestive problems, fever, hepatitis and hypertension etc. The common belief is, herbs are safe and easy to access as compared to conventional therapy, however, most of the studies reported different side effects which may be toxic at times. These adverse effects are mostly due to incorrect use or lack of patient education.

Parsley is a plant with antioxidant, diuretic and antimicrobial properties. Literature reported use of parsley as a diuretic by different communities in throughout the world. In vitro studies in animal have also reported the diuretic effect as well as proposed mechanisms for the use of parsley as diuretic however none of the studies have been conducted to investigate the diuretic effect of parsley in humans. This study aims to evaluate the diuretic and hence antihypertensive effect of parsley in hypertensive patients.


Condition or disease Intervention/treatment Phase
Diurnal Enuresis Hypertension Other: Natural Product Petroselinum crispum (Parsley) Other: Placebo Not Applicable

Detailed Description:
Parsley botanically known as Petroselinum crispum, belongs to the family Umbeliferae, originated from Mediterranean region however, it is cultivated almost throughout the world now-a-days. The plant has reported folkloric uses in different parts of the world; in Iran the seeds of the plant is used for different pharmacological effects including antimicrobial, kidney stones, digestive disorders etc., in Turkey the leaves of this plant is used to treat hypertension, diabetes and as a diuretic in Morocco the leaves are used for arterial hypertension, diabetes, high blood pressure and cardiac diseases in Spain the leaves of this plant are used to treat hypertension, diabetes, prostititis and anemia whereas in Serbia the leaves of the plant are used to treat urinary tract diseases and infections. Though the aforementioned literature supports the diuretic and anti-hypertensive potential of parsley however no in-vivo studies have been reported to establish its diuretic activity in human subjects. Some studies have reported diuretic activity for seed aqueous extract in rats. Still, to evaluate the effect in human subjects, an in-vivo phase-I clinical study is needed to support the pre-clinical in-vivo and in-vitro diuretic effects of this plant. Our study aims to investigate the diuretic and anti-hypertensive activity of parsley in hypertensive individuals currently using conventional medication.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Diuretic Effect Evaluation of Petroselinum Crispum (Parsley) in Hypertensive Patients (DEEP): Phase-I Clinical Trial
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control Group
Patients in control group will be allowed to continue their conventional medications and with a placebo.
Other: Placebo
Soft gelatin capsules will be filled with 1 gram of lactose (inert pharmaceutical ingredient) and will be administered to patients once daily.

Experimental: Intervention Group
Patients in intervention group who would be taking their usual medications along with parsley in a convenient dosage form.
Other: Natural Product Petroselinum crispum (Parsley)
Parsley herb, in fresh form will be obtained from the local market available. The herb will be properly washed with distilled water and dried properly for 10 to 15 days under shade in the lab. Soft gelatin capsules will be filled with parsley powder (dried herb) in amount normally recommended in daily routine (1g) will be administered to patients once daily.




Primary Outcome Measures :
  1. Change in baseline mean Blood pressure at day 7, day 14 and 21 [ Time Frame: For observing any change in mean blood pressure, a blood pressure monitor will be used to determine any variation in blood pressure in millimeters of mercury (mm of Hg). A total of four readings will be taken at baseline day 0, day 7, day 14 and day 21. ]
    For observing any change in mean blood pressure, a blood pressure monitor will be used to determine any variation in blood pressure in millimeters of mercury (mm of Hg).

  2. Change in baseline mean urinary output at day 7, day 14 and 21 [ Time Frame: For observing any change in mean urinary output a total of four readings will be taken at baseline day 0, day 7, day 14 and day 21. ]
    For observing any change in mean urinary output, a urine container will be used to determine any variation in urinary output in millimeters (ml).



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any male or female patients with hypertension and already using conventional medications i.e. antihypertensive drugs. The consent forms will be provided to the patients and only those patients which are willing to participate will be included in the study. Patients with more than 3 co-morbidities and at high-risk conditions will not be included in the study.

Exclusion Criteria:

  • Geriatric, pregnant and lactating patients will not be included in the study. More important, patients on diuretic medications as well as diabetes, will also be excluded from the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03468361


Locations
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Saudi Arabia
College of Clinical Pharmacy
Dammam, Eastern Province, Saudi Arabia, 31441
FAMCO
Khobar, Eastern, Saudi Arabia, 31441
Sponsors and Collaborators
Universiti Sains Malaysia
Imam Abdulrahman Bin Faisal University
Investigators
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Study Chair: Dhafar M Al Shayban, PhD Imam Abdulrahman Bin Faisal University
Study Director: Rasha Al Sheikh, MD FAMCO
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Responsible Party: Atta Abbas Naqvi, Prinicipal Investigator, Universiti Sains Malaysia
ClinicalTrials.gov Identifier: NCT03468361    
Other Study ID Numbers: IAU-DEEP
First Posted: March 16, 2018    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Enuresis
Diurnal Enuresis
Urination Disorders
Urologic Diseases
Behavioral Symptoms
Elimination Disorders
Mental Disorders