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Efficacy of jujube product in accelerating the recovery process of Covid -19 patients

Protocol summary

Study aim
Help improve respiratory symptoms and reduce hospitalization time and reduce costs and complications for patients with COVID-19
Design
Clinical trial with control group, with parallel, random, uncontrolled groups with pharmacotherapy, single center, sample size 68 people.
Settings and conduct
In addition to the treatment protocol, patients are given a corona treatment protocol with 14 cc of jujube product per day. Kosar Hospital in Semnan
Participants/Inclusion and exclusion criteria
All patients with Covid-19 symptoms in patients with a history of close contact with suspected people in the last 14 days, fever, pulmonary involvement, normal or reduced cbc, reduced lymphocyte, positive PCR involved in this study. patients with diabetes, Ketoacidosis, decompensated heart failure, severe kidney failure (GFR<30 ml/min), metabolic acidosis, severe respiratory failure, immediate need for intubation will exclude from the study.
Intervention groups
Intervention group: In addition to the treatment protocol, patients are given 7 cc of jujube product twice a day, 7 cc each. Control group: The treatment is done according to the protocol and is only for comparison with the intervention group.
Main outcome variables
3D CT Scans, dyspnea, cough, arterial oxygen saturation, PCR, CBC diff

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171213037866N2
Registration date: 2020-05-07, 1399/02/18
Registration timing: prospective

Last update: 2020-05-07, 1399/02/18
Update count: 0
Registration date
2020-05-07, 1399/02/18
Registrant information
Name
Nasim Behnoud
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4469 0358
Email address
behnoud.n@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-09, 1399/02/20
Expected recruitment end date
2020-08-20, 1399/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of jujube product in accelerating the recovery process of Covid -19 patients
Public title
Evaluation of the effect of jujube product on Covid-19 patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient does not suffer from any serious concomitant diseases of the pulmonary, cerebral, and endocrine glands The patient's ability and personal desire to fill out a personal consent form to enter the study The patient has not been intubated
Exclusion criteria:
Pregnancy and lactation Existence of any history of allergies to jujube and its products The patient's inability to take oral form There are any conditions in the patient that, according to the doctor's judgment, prevent the continuation of medical intervention. Concomitant use of corticosteroids, immunoglobulin or interferon Patient intubation Nausea and vomiting and oral intolerance Treatment-resistant hypoxemia Loss of consciousness Hemodynamic instability Hypercapnia - Respiratory fatigue Existence of any known side effects of consuming any of the components of jujube product
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 68
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization Using four blocks, we randomly arrange the patients using the rand section of the software and enter the study. The patient code table is provided to the analyst and will be used for analysis after the study.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the analyst and the recipient of the drug do not know how to allocate intervention and treatment groups. After accidentally entering the study, patients receive medication based on the received code and are unaware of the type of treatment.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2020-05-03, 1399/02/14
Ethics committee reference number
IR.SEMUMS.REC.1399.032

Health conditions studied

1

Description of health condition studied
COVID-19
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified

Primary outcomes

1

Description
Clinical symptoms (Coronavirus infection)
Timepoint
Before starting the study and daily until discharge
Method of measurement
Laboratory values and radiographic changes or CT scans and questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In addition to the treatment protocol, patients receive 7 cc of jujube twice a day, 7 cc each.
Category
Treatment - Drugs

2

Description
Control group: The treatment is done according to the protocol and is only for comparison with the intervention group.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Ali Gohari
Street address
Semnan Basij Boulevard Headquarters of Semnan University of Medical Sciences and Health Services
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3344 1022
Email
aligohari@semums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kokhaie
Street address
Semnan, Basij Boulevard, Central Headquarters of Semnan University of Medical Sciences, Deputy of Research and Technology
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
rds@semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
نسیم بهنود
Position
Non-faculty specialist physician of Semnan University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Semnan - Semnan: 17 Shahrivar Blvd., South Side of the School of Dentistry, Specialized and Subspecialty Polyclinic No. 2 - Health Center of Traditional Medicine Semnan University of Medical Sciences
City
Semnan
Province
Semnan
Postal code
9443135187
Phone
+98 23 3333 4623
Email
dr.nbehnoud@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ali Gohari
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Semnan Basij Boulevard Headquarters of Semnan University of Medical Sciences and Health Services
City
Semnan
Province
Semnan
Postal code
3518794431
Phone
+98 23 3344 1022
Email
aligohari@semums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Nasim Behnoud
Position
Non-faculty specialist physician of Semnan University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Semnan - Semnan: 17 Shahrivar Blvd., South Side of the School of Dentistry, Specialized and Subspecialty Polyclinic No. 2 - Health Center of Traditional Medicine Semnan University of Medical Sciences
City
Semnan
Province
Semnan
Postal code
3518794431
Phone
+98 23 3333 4623
Email
dr.nbehnoud@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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