Reduction of hospitalization period and failure to enter the critical phase and mortality.
Design
A clinical trial with a control group with a randomized parallel group.
Settings and conduct
In Amir Al-Momenin Hospital in Qom in two groups of intervention and control as follows:
Intervention group: FT® powder recipient along with the protocol of the Ministry of Health.
Control group: receive only the treatment protocol of the Ministry of Health.
Participants/Inclusion and exclusion criteria
Major entry conditions:
1. Inpatients diagnosed with Covid 19. 2. Patients with Covid 19 who wish to participate in the study. 3. No serious heart disease, liver, kidney, blood pressure above 160 mm Hg. 4. Patients who do not receive insulin. 5. Non-pregnancy in women. 6. A maximum of 48 hours have passed since the beginning of the patient's hospitalization.
Major conditions of non-entry:
1. Dissatisfaction with continuing treatment 2. Need to receive medical services in the intensive care unit.
Intervention groups
1. Intervention Description: Intervention group: Ministry of Health treatment protocol + FT® powder
Category: Therapy - Drugs
۲. Intervention description: Control group: Treatment protocol of the Ministry of Health
Classification: Control
Main outcome variables
1. Hospitalization days
۲. Clinical and vital signs
3. Mortality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150819023685N3
Registration date:2021-08-16, 1400/05/25
Registration timing:registered_while_recruiting
Last update:2021-08-16, 1400/05/25
Update count:0
Registration date
2021-08-16, 1400/05/25
Registrant information
Name
Samira Khani
Name of organization / entity
Qom University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 25 3783 2370
Email address
skhani@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-21, 1400/01/01
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of feneel_terminalia chebula (FT®)powder on clinical and paraclinical symptoms in patients with Covid 19.
Public title
Evaluation of the effectiveness of black halilah and fennel powder in clinical symptoms of patients with coronavirus.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inpatients diagnosed with Covid 19.
Patients with Covid 19 who wish to participate in the study
No serious heart disease, liver, kidney, blood pressure above 160 mm Hg
Patients who do not receive insulin
Non-pregnancy in women.
A maximum of 72 hours have passed since the beginning of the patient's hospitalization.
Exclusion criteria:
1. Dissatisfaction with continuing treatment.
2. Need to receive medical services in the intensive care unit.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Using the site https://www.sealedenvelope.com In the random list section, by entering the grouping A, B and the number of samples 70, as well as the volume of 2,4,8 blocks, we get a random list.
I consider one group as the intervention group and the other as the control group. Patients who meet the inclusion criteria are included in one of the groups according to the random list obtained.
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 Qom University of Medical Sciences
Street address
Safashahr St. - 1/1 Alley, Alley No. 4, No. 83
City
QOM
Province
Ghoum
Postal code
3713649373
Approval date
2020-07-21, 1399/04/31
Ethics committee reference number
IR.MUQ.REC.1399.154
Health conditions studied
1
Description of health condition studied
Covid19
ICD-10 code
U07.1
ICD-10 code description
Covid19
Primary outcomes
1
Description
Days of hospitalization
Timepoint
Daily
Method of measurement
View patient records
2
Description
Clinical signs
Timepoint
Before treatment and 2, 4, 7 days of treatment
Method of measurement
The severity of each of the patient's clinical symptoms is measured based on the visual analog scale in patients.
3
Description
Vital Signs
Timepoint
During hospitalization on a daily basis
Method of measurement
Monitoring device
Secondary outcomes
1
Description
Mortality
Timepoint
Daily patient follow-up
Method of measurement
View patient records
Intervention groups
1
Description
Intervention group: TherapIntervention group: Treatment protocol of the Ministry of Health + FT® powder, which contains a combination of black halibut powder and fennel with a natural sweetener and flavoring, which is prepared by a pharmacist. Pour a glass of beer and stir and sip.
Category
Treatment - Drugs
2
Description
Control group: This group includes patients who receive the routine medication regimen of the Ministry of Health and do not use the herbal powder that the intervention group receives; In this group, drugs such as remdesivir, corticosteroids, etc., which are commonly prescribed by doctors for patients with Quid 19, are used.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr.Shahid Beheshti_Amir Al-Momenin Hospital
Full name of responsible person
Mohammad Mahdi Fallahpour khoshdel
Street address
Amir Al-Momenin Hospital,Shahid Beheshti Blvd,Qom,3719964797,IRAN.