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

NCT03468361 | Withdrawn DMC

• 1 other identifier: IAU-DEEP
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Diurnal Enuresis; Hypertension

Outcome Measures

Primary Outcomes (2)

• Change in baseline mean Blood pressure at day 7, day 14 and 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).

  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.

• Change in baseline mean urinary output at day 7, day 14 and 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).

  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.

Study Arms (2)

Control Group

PLACEBO COMPARATOR

Patients in control group will be allowed to continue their conventional medications and with a placebo.

Other: Placebo

Intervention Group

EXPERIMENTAL

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)

Interventions

Natural Product Petroselinum crispum (Parsley) OTHER

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.

Intervention Group

Placebo OTHER

Soft gelatin capsules will be filled with 1 gram of lactose (inert pharmaceutical ingredient) and will be administered to patients once daily.

Control Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universiti Sains Malaysia: lead
• Imam Abdulrahman Bin Faisal University: collaborator

Study Sites (2)

College of Clinical Pharmacy

Dammam, Eastern Province, 31441, Saudi Arabia

Location

FAMCO

Khobar, Eastern Province, 31441, Saudi Arabia

Location

MeSH Terms

Conditions

Diurnal Enuresis; Hypertension

Condition Hierarchy (Ancestors)

Enuresis; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Dhafar M Al Shayban, PhD

  Imam Abdulrahman Bin Faisal University

  STUDY CHAIR

• Rasha Al Sheikh, MD

  FAMCO

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: March 11, 2018
• First Posted: March 16, 2018
• Study Start: March 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: January 31, 2020
• Last Updated: March 25, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

SA (2)