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Recruitment Status : Withdrawn (The hospitals could not enroll any patients.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
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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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
Placebo Comparator: Control Group
Patients in control group will be allowed to continue their conventional medications and with a 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.
- 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).
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|Ages Eligible for Study:||18 Years to 45 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
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
|College of Clinical Pharmacy|
|Dammam, Eastern Province, Saudi Arabia, 31441|
|Khobar, Eastern, Saudi Arabia, 31441|
|Study Chair:||Dhafar M Al Shayban, PhD||Imam Abdulrahman Bin Faisal University|
|Study Director:||Rasha Al Sheikh, MD||FAMCO|
|Responsible Party:||Atta Abbas Naqvi, Prinicipal Investigator, Universiti Sains Malaysia|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|