Protocol summary

Study aim
Investigating the effect of oral supplementation containing jujube and saffron on recovery and controlling the symptoms of patients with covid-19
Design
A clinical trial with control group, parallel groups, double-blind, randomized, phase 2-3 on 60 patients. Random allocation software has used for randomization.
Settings and conduct
Valiasr Hospital, Birjand; After obtaining informed written consent, patients will be randomly divided into 2 groups (placebo and supplement). A standard treatment will be provided for both. The duration of the intervention is 2 weeks and the received dose is equal to 15 ml of the supplement three times a day after each meal orally. Tests and examinations of patients will be performed daily. During the study, with the exception of the pharmacist (who has no role in the clinical study and evaluations), the rest of the project partners, including infectious disease specialists, radiologists, nurses, and project analysts, will not know how the drug and placebo are allocated.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Clinical or paraclinical confirmation of Covid-19; Absence of underlying disease including diabetes, thyroid disorders, cardiovascular, autoimmune, hemorrhagic, and other lung diseases; No pregnancy and lactation. Exclusion criteria: Patients with a severe form of Corona disease (patients under ventilator, patients with oxygen saturation percentage below 88 mm Hg, and patients admitted to the ICU), Patient's unwillingness to continue the project; Sensitivity to the components of supplement.
Intervention groups
Intervention group includes patients with Corona who receive supplements containing jujube and saffron. Comparison group includes patients with Corona who receive placebo intervention.
Main outcome variables
radiological changes, duration of hospitalization, body temperature, cough rate, CBC indices

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160305026917N2
Registration date: 2021-05-25, 1400/03/04
Registration timing: prospective

Last update: 2021-05-25, 1400/03/04
Update count: 0
Registration date
2021-05-25, 1400/03/04
Registrant information
Name
Sayyedeh Fatemeh Askari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3238 1919
Email address
stud0653219921@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-21, 1400/04/30
Expected recruitment end date
2022-01-20, 1400/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of oral supplementation containing jujube and saffron on recovery and controlling the symptoms of patients with covid-19
Public title
The effect of jujube and saffron supplement on Covid-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Clinical or paraclinical confirmation of disease Absence of underlying disease including diabetes, thyroid disorders, cardiovascular, autoimmune, and hemorrhagic and other lung diseases No pregnancy and breastfeeding.
Exclusion criteria:
Patients with severe forms of the disease (patients under ventilator, patients with oxygen saturation below 88 mm Hg, and patients admitted to the ICU The patient's unwillingness to continue participating in the project Sensitivity to the components of the supplement.
Age
From 15 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized double-blind controlled clinical trial randomization using random allocation software According to the randomization, each supplement or placebo sample is assigned a number and the patient will not be informed about taking the drug or placebo (Numbers from 1 to 60).
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients will be notified to participate in the study and obtaining a consent form but they will be blind to the supplements or placebo. During the study, with the exception of the pharmacist (who has no role in the clinical study and evaluations), the rest of the project partners, including infectious disease specialists, radiologists, nurses, and project analysts, will not know how the drug and placebo are allocated. Supplement and placebo are also identical in appearance so that they are not recognizable to patients.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Birjand University of Medical Sciences
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Approval date
2021-05-17, 1400/02/27
Ethics committee reference number
IR.BUMS.REC.1400.054

Health conditions studied

1

Description of health condition studied
Covid-19
ICD-10 code
U07.1
ICD-10 code description
Covid-19

Primary outcomes

1

Description
Investigation of radiological changes
Timepoint
0 (before the intervention), 7th, 14th day after intervention
Method of measurement
Computed tomography scan

2

Description
Coughing
Timepoint
0 (before the start of the intervention) - 14th day after intervention
Method of measurement
Based on Visual Analogue Scale

3

Description
Complete blood count indices
Timepoint
0 (before the intervention), 7th, 14th day after intervention
Method of measurement
Complete blood count test

Secondary outcomes

1

Description
Duration of hospitalization
Timepoint
After the patient is discharged
Method of measurement
The number of days of hospitalization

2

Description
Body temperature
Timepoint
0 (before the start of the intervention) - 14th day after intervention
Method of measurement
Thermometer

Intervention groups

1

Description
Intervention group: Standard treatment will be performed and a saffron-jujube supplement will be prescribed with it for 30 patients. The duration of the intervention is 2 weeks and the received dose is equal to 15 ml of the supplement three times a day after each meal orally. On the zero-day, during consumption, and on the 7th and 14th days of the intervention, the relevant variables are measured.
Category
Treatment - Drugs

2

Description
Control group: Standard treatment will be performed and placebo will be prescribed with it for 30 patients. The placebo does not contain saffron and jujube. The duration of the intervention is 2 weeks and the received dose is equal to 15 ml of the supplement three times a day after each meal orally. On the zero-day, during consumption, and on the 7th and 14th days of the intervention, the relevant variables are measured.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr Hospital, Birjand
Full name of responsible person
Sayyedeh Fatemeh Askari
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1919
Email
sfaskari98@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Toba kazemi
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1919
Email
sfaskari98@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Sayyedeh Fatemeh Askari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Phytopharmaceuticals
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1919
Email
sfaskari98@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Sayyedeh Fatemeh Askari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Phytopharmaceutical
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1919
Email
sfaskari98@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Sayyedeh Fatemeh Askari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Phytopharmaceutical
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1919
Email
sfaskari98@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
Undecided - It is not yet known if there will be a plan to make this available
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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