The effect of Persian Medicine Formula (Padzahr) on clinical manifestations of patients with COVID-19
Design
68 patients between the ages of 18 and 75 with a probable diagnosis of COVID-19 according to the national protocol, after applying the inclusion and exclusion criteria of the study and completing the conscious consent form with block randomization are placed in one of the intervention and control groups.
Settings and conduct
This study is a type of clinical trial that is not blind and patients who refer to Razi Hospital in Ghaemshahr are diagnosed with COVID-19 manifestation will entered. Then, 68 patients between the ages of 18 and 75 with a probable diagnosis of COVID-19 according to the national protocol, after applying the inclusion and exclusion criteria of the study and completing the conscious consent form with block randomization are placed in one of the intervention and control groups.
Participants/Inclusion and exclusion criteria
Patients between 18 and 75 years with Probable diagnosis of COVID-19 based on national Iranian protocol
Intervention groups
Intervention group: Corona standard treatment + 2 Padzahr tables: after a meal (three times a day). Control group: Corona standard treatment according to the national protocol of the Ministry of Health of Iran.
Main outcome variables
length of hospital stay
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131129015584N4
Registration date:2021-04-04, 1400/01/15
Registration timing:prospective
Last update:2021-04-04, 1400/01/15
Update count:0
Registration date
2021-04-04, 1400/01/15
Registrant information
Name
Assie Jokar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3324 3117
Email address
arezoo2003dr@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Persian Medicine Formula (Padzahr) on clinical manifestations of patients with COVID-19
Public title
The effect of Padzahr tablets on the symptoms of COVID-19
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Probable diagnosis of COVID-19 based on national Iranian protocol
Exclusion criteria:
Late 5 days from the onset of symptoms
Existence of comorbidity
Pregnancy and lactation
history of Allergy
Complicated with bacterial infection
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Before entering the intervention, each patient selected one of the 68 envelopes containing the codes 0001 to 0068, which was already randomly determined for each code using the Block randomization statistical software output table for each intervention group. Or assigned control. The participants will be assigned to the intervention groups in 17 blocks of 4 in a ratio of one to one (1: 1 Allocation) in order of allocation.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Moallem square
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Approval date
2021-02-24, 1399/12/06
Ethics committee reference number
IR.MAZUMS.REC.1399.967
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
Fever reduction time
Timepoint
Time to start reducing fever after the intervention
Method of measurement
hour
2
Description
Fever intensity
Timepoint
All days of hospitalization
Method of measurement
C
3
Description
Blood oxygen saturation
Timepoint
All days after the intervention
Method of measurement
Pulse oximetry
Secondary outcomes
1
Description
Duration of hospital stay
Timepoint
Patient discharge time
Method of measurement
day
Intervention groups
1
Description
Intervention group: Corona treatment (1- Remedicivir: 200 mg on the first day and then 100 mg daily for 4 days; 2- Dexamethasone: 8 mg daily; 3- Enoxaparin 40 mg every 12 hours or Heparin 5000 units every 8 hours) + Padzahr tablets (made by NIAK with license number 0385-94-S): 2 pieces, after meals (three times a day).
Category
Treatment - Drugs
2
Description
Control group: Corona treatment (1- Remedicivir: 200 mg on the first day and then 100 mg daily for 4 days; 2- Dexamethasone: 8 mg daily; 3- Enoxaparin 40 mg every 12 hours or Heparin 5000 units every 8 hours)