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effect of Hesperidin,Artemisinin- Artemisia annua, Noscapine, N-acetylcysteine, Resveratrol supplements and high dose of vitamin C on treatment, clinical symptoms of non-hospitalization and hospitalization patients with symptomatic COVID-19

Protocol summary

Study aim
Determination of the effect of Hesperidin,Artemisinin- Artemisia annua, Noscapine, N-acetylcysteine, Resveratrol supplements and high dose of vitamin C on treatment, clinical symptoms of non-hospitalization and hospitalization patients with symptomatic COVID-19
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 per 100 patients. Block randomization method was used .
Settings and conduct
The study will be performed at Imam Reza Hospital in Sirjan. 25 patients in all four groups with symptomatic Covid-19 virus will be identified with the same .Hesperidin,Artemisinin- Artemisia annua, Noscapine, N-acetylcysteine, Resveratrol supplements and high dose of vitamin C With specific doses will be received in the intervention groups and the control groups will receive the National Protocol of the Ministry of Health. In this study, the work will be a double-blind clinical trial (Participant, Evaluator, Data analyst, Data safety and Monitoring committee)
Participants/Inclusion and exclusion criteria
Inclusion criteria: COVID-19 virus infection,Clinical symptoms, Lymphocytes less than 15%, Lung involvement in CT scan, Oxygen level less than 93%, Unstable vital signs Exclusion criteria: Allergy to oral supplements and high doses of vitamin C, Pregnant and lactating women, Patients with seizures Dialysis patients
Intervention groups
Intervention group: non-hospitalization patients received Supplements and high dose of vitamin C Intervention group: hospitalization patients received Supplements and high dose of vitamin C Control group: non-hospitalization patients received Protocol of the Ministry of Health Control group: hospitalization patients received Protocol of the Ministry of Health
Main outcome variables
LDH, CBC diff, Na / K / Ca, CRP, ESR1, Weakness and nausea, Respiratory quality

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181030041504N1
Registration date: 2020-11-08, 1399/08/18
Registration timing: retrospective

Last update: 2020-11-08, 1399/08/18
Update count: 0
Registration date
2020-11-08, 1399/08/18
Registrant information
Name
masoomeh mohamadpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8860 7357
Email address
mohamadpour.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-07, 1399/07/16
Expected recruitment end date
2020-11-05, 1399/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effect of Hesperidin,Artemisinin- Artemisia annua, Noscapine, N-acetylcysteine, Resveratrol supplements and high dose of vitamin C on treatment, clinical symptoms of non-hospitalization and hospitalization patients with symptomatic COVID-19
Public title
Evaluation of the combined effect of Hesperidin,Artemisinin- Artemisia annua, Noscapine, N-acetylcysteine, Resveratrol supplements and high dose of vitamin C on treatment, clinical symptoms of non-hospitalization and hospitalization patients with symptomatic COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
COVID-19 virus infection by RT-PCR in non-hospitalization and hospitalization patients G6PD sufficient in non-hospitalization and hospitalization patients Lack of clinical response to routine outpatient treatment in non-hospitalization and hospitalization patients Clinical symptoms (fever, cough, myalgia, shortness of breath, digestive problems) in non-hospitalization and hospitalization patients Age over 12 years in non-hospitalization and hospitalization patients Patient satisfaction in non-hospitalization and hospitalization patients Lymphocytes less than 15%, respiratory distress, lung involvement on CT scan, oxygen level less than 93%, unstable vital signs, severe gastrointestinal symptoms and oral intolerance, underlying disease Except for exclusion cases hospitalization patients
Exclusion criteria:
Allergy to oral supplements and high doses of vitamin C Reluctance to continue participating in the trial for any reason Patients admitted to the intensive care unit (ICU) (patients who have been admitted to the ICU since admission) Pregnant and lactating lady Patients with seizures Dialysis patients
Age
From 12 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
For this purpose, we will use the quadruple block method (Block Randomization). Random allocation software will be used for this purpose. We prepare two sheets of paper. On a sheet we write the letter I meaning "Intervention" and on a sheet the letter S means "Standard treatment". Mix the sheets together and place them in the desk drawer. With the referral of each eligible patient, one of the leaflets will be randomly taken out and based on this extracted leaflet will be assigned to one of the two intervention groups. It should be noted that the pulled out sheets will not be returned to the drawer until all four sheets have been pulled out. After accidentally pulling out all four sheets, all the sheets are returned to the drawer and the above procedure will be continued for the next four patients until the desired sample size is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participant, Evaluator, Data analyst, Data safety and Monitoring committee
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
sirjan faculty of medical science
Street address
sirjan - Seyyed Jamaledin Asad Abadi Blvd - Parks of Traffic - Sirjan University of Medical Sciences
City
sirjan
Province
Kerman
Postal code
7816916338
Approval date
2020-10-07, 1399/07/16
Ethics committee reference number
IR.SIRUMS.REC.1399.033

Health conditions studied

1

Description of health condition studied
covid-19
ICD-10 code
RA01.0
ICD-10 code description
Severe Acute Respiratory Syndrome coronavirus

Primary outcomes

1

Description
LDH
Timepoint
Before the intervention and ten days after the intervention
Method of measurement
Blood Test

2

Description
CBC diff
Timepoint
Before the intervention and ten days after the intervention
Method of measurement
Blood Test

3

Description
Na/K/Ca
Timepoint
Before the intervention and ten days after the intervention
Method of measurement
Blood Test

4

Description
CRP
Timepoint
Before the intervention and ten days after the intervention
Method of measurement
Blood Test

5

Description
ESR1
Timepoint
Before the intervention and ten days after the intervention
Method of measurement
Blood Test

6

Description
Weakness and nausea
Timepoint
Before the intervention and ten days after the intervention
Method of measurement
Check List

7

Description
Lung involvement
Timepoint
Before the intervention and ten days after the intervention
Method of measurement
CT-Scan

Secondary outcomes

1

Description
Determination of the effect of Hesperidin,Artemisinin- Artemisia annua, Noscapine, N-acetylcysteine, Resveratrol supplements and high dose of vitamin C on on oxygen
Timepoint
10 day
Method of measurement
Pulse Oximeter

2

Description
General condition of people and vitality after treatment
Timepoint
10 day
Method of measurement
Examination and history

Intervention groups

1

Description
Intervention group: non-hospitalization patients with symptomatic COVID-19 received 1. Artemisia annua - Artemisinin ( Manufactured by Longlifenutri)150 mg every 24 hours 2. Dose of 1 g of vitamin C (Manufactured by Daroupakhsh) intravenous vitamin (2 ampoules of 500 mg in 250 cc of sodium chloride serum for 30 minutes) every 24 hours 3. Dose of 5 cc of noscapine ( Manufactured by Faran Shimi) each Eight hours 4. 500 mg dose of hesperidin (Manufactured by Swanson) every 24 hours 5. Resveratrol 500 mg (Manufactured by A Squard) every 24 hours 6. NAC 600 mg ( Manufactured by Osvah ) every 12 hours . The duration of treatment is estimated at ten days. Supplements are taken orally and vitamin C is given to patients as an injection
Category
Treatment - Drugs

2

Description
Control group: non-hospitalization patients with symptomatic COVID-19 Protocol of the Ministry of Health
Category
Treatment - Drugs

3

Description
Intervention group: hospitalization patients with symptomatic COVID-19 received 1. Artemisia annua - Artemisinin ( Manufactured by Longlifenutri)150 mg every 12hours 2. Dose of 1 g of vitamin C (Manufactured by Daroupakhsh) intravenous vitamin (2 ampoules of 500 mg in 250 cc of sodium chloride serum for 30 minutes) every 12 hours 3. Dose of 5 cc of noscapine ( Manufactured by Faran Shimi) each Eight hours 4. 500 mg dose of hesperidin (Manufactured by Swanson) every 24 hours 5. Resveratrol 500 mg (Manufactured by A Squard) every 24 hours 6. NAC 600 mg ( Manufactured by Osvah ) every 12 hours . The duration of treatment is estimated at ten days.Supplements are taken orally and vitamin C is given to patients as an injection
Category
Treatment - Drugs

4

Description
Control group: hospitalization patients with symptomatic COVID-19 Protocol of the Ministry of Health
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
بیمارستان امام رضا
Full name of responsible person
دکتر علی امجدی
Street address
خیابان هجرت - بیمارستان امام رضا
City
سیرجان
Province
Kerman
Postal code
7816916338
Phone
+98 34 4152 4452
Email
Aamjadi50@yahoo.com
Web page address
http://emamrezahp.sirums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sirjan Faculty of Medical Science
Full name of responsible person
Dr.Mahood reza Masoudi
Street address
Seyyed Jamaledin Asad Abadi Blvd - Parks of Traffic
City
Sirjan
Province
Kerman
Postal code
7816916338
Phone
+98 34 4227 3696
Email
ssm@sirums.ac.ir
Web page address
http://www.sirums.ac.ir/index.php?option=com_content&view=featured&Itemid=102&lang=en
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sirjan Faculty of Medical Science
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
Sirjan Faculty of Medical Science
Full name of responsible person
Dr.Ali,Amjadi
Position
Non-faculty specialist physician
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Seyyed Jamaledin Asad Abadi Blvd - Parks of Traffic
City
Sirjan
Province
Kerman
Postal code
7816916338
Phone
+98 34 4234 0640
Email
Aamjadi50@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rayan Research Company
Full name of responsible person
Dr. Masoomeh Mohamadpour
Position
Managing Director
Latest degree
Ph.D.
Other areas of specialty/work
Anatomical-cellular and molecular sciences
Street address
No 16, Gisha Ave
City
tehran
Province
Tehran
Postal code
1448643643
Phone
+98 21 8827 5219
Email
m.mohamadpour2817@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Rayan Research Company
Full name of responsible person
Dr. Masoomeh Mohamadpour
Position
Managing Director
Latest degree
Ph.D.
Other areas of specialty/work
Anatomical-cellular and molecular sciences
Street address
No. 16, Gisha Ave
City
tehran
Province
Tehran
Postal code
1448643643
Phone
+98 21 8827 5219
Email
m.mohamadpour2817@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Main outcome data, statistical analysis, final report, informed consent form
When the data will become available and for how long
6 months after publish the results
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Master of Medical Sciences PhD in Medical Sciences specialist Contribute to the advancement of science
From where data/document is obtainable
Email m.mohamadpour2817@yahoo.com Contact number: 09120031782 Dr. Masoomeh Mohamadpour - Tehran
What processes are involved for a request to access data/document
48-72 hours after sending the email request
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