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

NCT ID: NCT03468361

Last Updated: 2020-03-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2020-01-31

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.

Conditions

Diurnal Enuresis; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Control Group

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Intervention Group

Patients in intervention group who would be taking their usual medications along with parsley in a convenient dosage form.

Group Type: EXPERIMENTAL

Natural Product Petroselinum crispum (Parsley)

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Placebo

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

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Imam Abdulrahman Bin Faisal University

OTHER

Sponsor Role: collaborator

Universiti Sains Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Atta Abbas Naqvi

Prinicipal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dhafar M Al Shayban, PhD

Role: STUDY_CHAIR

Imam Abdulrahman Bin Faisal University

Rasha Al Sheikh, MD

Role: STUDY_DIRECTOR

FAMCO

Locations

College of Clinical Pharmacy

Dammam, Eastern Province, Saudi Arabia

FAMCO

Khobar, Eastern Province, Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

IAU-DEEP

Identifier Type: -

Identifier Source: org_study_id