Efficacy of Date Palm Leaf Extract (Phoenix dactylifera) in Patients with COVID-19 Hospitalized in Ganjavian Hospital in Dezful

• Register: IRCT
• Last refreshed on: 30 November 2020
• Main ID: IRCT20201015049036N1
• Date of registration: 2020-11-27
• Prospective Registration: No
• Primary sponsor: Dezfoul University of Medical Sciences
• Public title: Efficacy of Date Palm Leaf Extract (Phoenix dactylifera) in Patients with COVID-19 Hospitalized in Ganjavian Hospital in Dezful
• Scientific title: Efficacy of Palm Leaf Extract (Phoenix dactylifera) in Patients with COVID-19 Patients Admitted to Ganjavian Hospital in Dezful with Mild to Moderate Stages: A Randomized Clinical Trial
• Date of first enrolment: 2020-09-12
• Target sample size: 100
• Recruitment status: Complete
• URL: http://en.irct.ir/trial/51772
• Study type: interventional
• Study design: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: The study will be conducted in cooperation with infectious and internal specialists and pulmonary specialists, Randomization description: Patients with inclusion criteria and with respect to their genders will be assessed clinically. The patients will be divided into to two groups randomly: drug recipients and placebo recipients. The patients will be assigned certain codes, and only the pharmacy team will be aware of the nature of the two groups. The physician in chief, the nurses and the patients are not aware of whether they are receiving drug or placebo.placebo of the syrup, Blinding description: Patients use drugs and placebo that are in exactly the same containers and labels but have different codes, and except for the pharmacy team, none of the treating physicians, nurses, and patients are aware of those codes.
• Phase: 2

Countries of recruitment

Iran (Islamic Republic of)

Contacts

• Name: Mohammad Dorchin
• Affiliation: Dezfoul University of Medical Sciences

• Name: Mohammad Dorchin
• Affiliation: Dezfoul University of Medical Sciences

Key inclusion & exclusion criteria

Inclusion criteria: Patients >12 years of age (male/female) with mild to moderate disease, which can be determined by clinical criteria (dry cough, fever and dyspnea) and paraclinical indices PO2, PCR, CT Scan, CRP, CBC
Signing the form of consent by persons >18 years of age or the guardians of the under-aged patients
Exclusion criteria: Dissatisfaction of patients or the patients' guardians
Any allergic reactions from the use of the palm extract
Critically ill patients or the cases where the physician in chief may not recommend this intervention for hospitalized patients

Age minimum: 12 years
Age maximum: 80 years
Gender: Both

Health Condition(s) or Problem(s) studied

Coronavirous (COVID19).
Corona virus infection, unspecified

U07.1

Intervention(s)

Intervention 1: Intervention group: treatment- medicine: Phoenix medicine (contains hydro alcoholic solution, Phoenix leaf extract, Vitamin C and Strawberry flavoring) 5 times/day, each time 5 ml. Intervention 2: Control group: treatment-placebo: contains hydro alcoholic solution, Vitamin C , Strawberry flavoring, without Phoenix leaf extract) 5 times/day, each time 5 ml.

Primary Outcome(s)

Virus diagnosis. Timepoint: At the beginning of entering the plan, at the end of the first week of treatment and at the end of the second week of treatment. Method of measurement: PCR.

WBC: white blood cell. Timepoint: At the beginning of entering the plan, at the end of the first week of treatment and at the end of the second week of treatment. Method of measurement: Comparison with normal standard range in blood test.

ESR: erythrocyte sedimentation rate used to monitor inflammatory diseases. Timepoint: At the beginning of entering the plan, at the end of the first week of treatment and at the end of the second week of treatment. Method of measurement: Comparison with normal standard range in blood test.

CRP: reactive protein in blood for detect the inflammation. Timepoint: At the beginning of entering the plan, at the end of the first week of treatment and at the end of the second week of treatment. Method of measurement: Comparison with normal standard range in blood test.

Fever. Timepoint: At the beginning of entering the plan, at the end of the first week of treatment and at the end of the second week of treatment. Method of measurement: Thermometer.

Lung infection. Timepoint: At the beginning of entering the plan, at the end of the first week of treatment and at the end of the second week of treatment. Method of measurement: CT Scan.

PaO2: oxygen pressure in arterial blood. Timepoint: At the beginning of entering the plan, at the end of the first week of treatment and at the end of the second week of treatment. Method of measurement: Record the degree of oxygen pressure.

Source(s) of Monetary Support

University

Ethics review

Status: Approved
Approval date: 06/10/2020
Contact:

Ethics Committee Dezful University of Medical Sciences