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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Recruitment Status : Withdrawn (The hospitals could not enroll any patients.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

Tracking Information
First Submitted Date  ICMJE March 11, 2018
First Posted Date  ICMJE March 16, 2018
Last Update Posted Date March 25, 2020
Actual Study Start Date  ICMJE March 1, 2018
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2018)
  • 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).
  • 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diuretic Effect Evaluation of Petroselinum Crispum (Parsley) in Hypertensive Patients
Official Title  ICMJE Diuretic Effect Evaluation of Petroselinum Crispum (Parsley) in Hypertensive Patients (DEEP): Phase-I Clinical Trial
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.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Diurnal Enuresis
  • Hypertension
Intervention  ICMJE
  • 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.
  • Other: Placebo
    Soft gelatin capsules will be filled with 1 gram of lactose (inert pharmaceutical ingredient) and will be administered to patients once daily.
Study Arms  ICMJE
  • Placebo Comparator: Control Group
    Patients in control group will be allowed to continue their conventional medications and with a placebo.
    Intervention: Other: Placebo
  • Experimental: Intervention Group
    Patients in intervention group who would be taking their usual medications along with parsley in a convenient dosage form.
    Intervention: Other: Natural Product Petroselinum crispum (Parsley)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: March 23, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: March 11, 2018)
50
Estimated Study Completion Date  ICMJE January 31, 2020
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Saudi Arabia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03468361
Other Study ID Numbers  ICMJE IAU-DEEP
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Atta Abbas Naqvi, Universiti Sains Malaysia
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Universiti Sains Malaysia
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Imam Abdulrahman Bin Faisal University
Investigators  ICMJE
Study Chair: Dhafar M Al Shayban, PhD Imam Abdulrahman Bin Faisal University
Study Director: Rasha Al Sheikh, MD FAMCO
PRS Account Universiti Sains Malaysia
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP