View older revisions Content changed at 2021-01-07, 1399/10/18

Protocol summary

Study aim
Evaluation of the effectiveness of two herbal products containing noscapine (opiucough and noscatem) in the treatment of patients with COVID 19 as well as reduction of mortality or disability due to (SARS-CoV-2)
Design
The present study was a clinical trial with a control group, with parallel, randomized groups, on 120 patients (40 patients in each group).
Settings and conduct
Sampling will be performed in Imam Reza Hospital and after obtaining informed consent from eligible patients, all of them were first matched in terms of the main clinical variable (pulmonary function test) and then randomly divided into groups 1- control, 2-intervention 1, and 3-intervention 2. The treatment time is considered 14 days.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Hospitalized patients who are strongly suspected of having COVID 19 disease in terms of clinical findings and CT scan findings, and are clinically classified and hospitalized as severe, but have no organ damage, Confirmation of RT-PCR test for SARS-CoV-2, Age under 80 years, Confirmation of pneumonia by chest x-ray, Blood oxygen saturation below 93%, The relative stability of the cardiovascular status. Exclusion criteria: pregnant and lactating women, End-stage patients
Intervention groups
Control group: routine treatment based on physician's opinion and receiving 10 cc placebo syrup (made by Mashhad University of Medical Sciences) every 8 hours for 14 days Intervention group 1: routine treatment based on physician's opinion and receiving 10 cc opioucough syrup (made by Sepidaj Co.) every 8 hours for 14 days Intervention group 2: routine treatment based on the doctor's opinion and receiving Noscatem (made by Temad Co.) syrup 10 cc every 8 hours for 14 days
Main outcome variables
Recovery time, Hospital discharge, laboratory parameters

General information

Reason for update
Due to the unavailability of Noscaough syrup and also the purity of Noscatem syrup (containing Noscapine alone).
Acronym
IRCT registration information
IRCT registration number: IRCT20180103038199N3
Registration date: 2020-08-30, 1399/06/09
Registration timing: prospective

Last update: 2021-01-07, 1399/10/18
Update count: 2
Registration date
2020-08-30, 1399/06/09
Registrant information
Name
Vahid Reza Askari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3800 2264
Email address
askariv941@mums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
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
Evaluation and comparison of the effectiveness of two herbal products containing Noscapine (Opiucough and Noscatem) on clinical symptoms and para-clinical parameters in adults hospitalized with severe COVID-19
Public title
effects of two products containing Noscapine on COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are strongly suspected of having COVID 19 disease in terms of clinical findings and CT scan findings Patients who are clinically classified and hospitalized as severe Patients who have no organ damage. Confirmation of RT-PCR test for SARS-CoV-2 Age under 80 years confirmation of pneumonia by chest x-ray Blood oxygen saturation below 93% Relative stability of the cardiovascular status
Exclusion criteria:
Pregnant women Lactating women End stage patients
Age
To 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done based on the table of random numbers using Excel software and with the Randbetween command between 120 samples. The bottles will be named including 40 bottles of syrup of control group (A) that have the same appearance as the intervention group, 40 bottles of syrup of intervention group 1 (B) that receive opiucough syrup, 40 bottles of syrup of intervention group 2 (C) that receive Noscatem syrup. Patients numbers from 000-040, 040-080 and 080-120 are considered for groups B, A, and C, respectively.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Deputy of Research and Technology of the University, Qurashi Building, Next to Hoveyzeh Cinema, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2020-05-23, 1399/03/03
Ethics committee reference number
IR.MUMS.REC.1399.283

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
Recovery time from the time of randomization of the studied patients to the improvement of clinical symptoms based on 7 common signs of improvement reported by the World Health Organization
Timepoint
before and 14 days after initiation of the intervention
Method of measurement
Relative criteria based on clinical symptoms as follows, 1: not hospitalized with resumption to normal activities, 2: not hospitalized but unable to resume normal activities, 3: hospitalized without the need for oxygen therapy, 4: hospitalized requiring supplemental oxygen, 5: hospitalized and need to receive high-speed oxygen from the nose or non-invasive ventilation or both, 6: hospitalized and need to receive oxygen using invasive ventilation or oxygen delivery from non-pulmonary routes or both, 7: death

2

Description
Hospital discharge
Timepoint
After initiation of the intervention
Method of measurement
Duration of hospitalization

Secondary outcomes

1

Description
Blood level of alanine aminotransferase (ALT)
Timepoint
Before and 14 days after initiation of the intervention
Method of measurement
spectrometer

2

Description
Blood urea nitrogen (BUN) level
Timepoint
Before and 14 days after initiation of the intervention
Method of measurement
spectrometer

3

Description
Blood creatinine level
Timepoint
Before and 14 days after initiation of the intervention
Method of measurement
spectrometer

4

Description
Blood level of aspartate aminotransferase (AST)
Timepoint
Before and 14 days after initiation of the intervention
Method of measurement
spectrometer

5

Description
Red blood cell counts
Timepoint
Before and 14 days after initiation of the intervention
Method of measurement
Cell Counter

6

Description
White blood cell counts
Timepoint
Before and 14 days after initiation of the intervention
Method of measurement
Cell Counter

7

Description
Hemoglobin level
Timepoint
Before and 14 days after initiation of the intervention
Method of measurement
Autoanalyzer

8

Description
Hematocrit level
Timepoint
Before and 14 days after initiation of the intervention
Method of measurement
Autoanalyzer

9

Description
erythrocyte sedimentation rate
Timepoint
Before and 14 days after initiation of the intervention
Method of measurement
Wintrobe method

10

Description
high-sensitivity C-reactive protein
Timepoint
Before and 14 days after initiation of the intervention
Method of measurement
ELISA kit

Intervention groups

1

Description
Control group: Routine treatment based on physician's opinion and receive placebo syrup (dextrous syrup 60% and edible color, made by Mashhad University of Medical Sciences) 10 cc every 8 hours for 14 days
Category
Placebo

2

Description
Intervention group1: Opiucough Syrup - Receive routine treatment and 10 cc of Opiucough syrup (containing 17 mg noscapine per 10 ml, commercially available, Sepidaj Co.) every 8 hours for 14 days
Category
Treatment - Drugs

3

Description
Intervention group2: Opiucough Syrup - Receive routine treatment and 10 cc of Noscatem syrup (containing 17 mg noscapine per 10 ml, commercially available, Temad Co.) every 8 hours for 14 days
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
22 Bahman Hospital, Neishabour
Full name of responsible person
Amir Beik Mohammadi
Street address
22 Bahman Hospital, Imam Ave.,
City
Neishabour
Province
Razavi Khorasan
Postal code
9177745346
Phone
+98 51 3800 2259
Email
amir_dr64@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Deputy of Research and Technology of the University , Qurashi Building, Next to Hoveyzeh Cinema, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
RIS@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Vahid Reza Askari
Position
PhD of clinical pharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Persian and Complementary Medicine, Ferdowsi complex, Vakil-Abad Blvd., Azadi Sq., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2259
Fax
Email
askariv@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Vahid Reza Askari
Position
PhD of clinical pharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Persian and Complemantary Medicine, Ferdowsi Complex, Vakil-Abad Blvd., Azadi Sq., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2259
Fax
Email
askariv@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Vahid Reza Askari
Position
PhD of clinical pharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Persian and Complementary Medicine, Ferdowsi Complex, Vakil-Abad Blvd., Azadi Sq., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2259
Fax
Email
askariv@mums.ac.ir

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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