1. Home
  2. Approved trials
  3. » فارسی

Effect of Opontia Cactus extract on improving pulmonary and clinical function in patients with Covid-19

Protocol summary

Study aim
Determining the effect of Opuntia cactus extract on improving blood oxygenation, shortening the length of hospital stay, improving headaches, reducing myalgia and shortening the period of weakness and lethargy of patients
Design
Matched clinical trial with control group, double blinded
Settings and conduct
In this double blind randomized clinical trial with parallel design, 48 patients with moderate Covid-19 severity inpatients in Imam Ali hospital will be allocated to intervention or standard treatment using balanced block randomization method.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Lung CT scan or PCR are appropriate for Covid-19 disease Age 18 to 60 years The oxygen saturation more than 90% Exclusion criteria: Taking supplements Receiving mechanical ventilation Multi organ failure
Intervention groups
Twenty-fore patients will receive 250 cc syrup of Opuntia cactus daily, for 7 days in the morning, and another 24 patients in control group will receive 250 cc syrup of apple extract. Shortness of breath, body aches, headaches, weakness, venous blood oxygen and body temperature will be checked.
Main outcome variables
Improving pulmonary function, measured by measuring venous blood oxygen؛ Improving clinical performance by following the patient's clinical symptoms such as body temperature, body aches, cough, shortness of breath, headache, and weakness.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200504047298N2
Registration date: 2020-06-15, 1399/03/26
Registration timing: prospective

Last update: 2020-06-15, 1399/03/26
Update count: 0
Registration date
2020-06-15, 1399/03/26
Registrant information
Name
Zeinab Siami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4602 2136
Email address
z.siami@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-10, 1399/04/20
Expected recruitment end date
2020-07-26, 1399/05/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Opontia Cactus extract on improving pulmonary and clinical function in patients with Covid-19
Public title
Effect of Opuntia Cactus extract in patients with Covid-19
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have CT scan or PCR data in accordance with Covid-19 Patients aged 18 to 60 years Patients who have not hypoxemia (oxygen saturation more than 90%)
Exclusion criteria:
Patients who taking herbal supplements are excluded Patients who were receiving mechanical ventilation or extracorporeal membrane oxygenation (ECMO) ، are excluded Patients with signs of multiorgan failure at screening (Exclusion criteria included alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 5 times the upper limit of the normal range or estimated creatinine clearance of less than 50 ml per minute (by the Cockcroft–Gault formula)) are excluded
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
In the current study, patients were randomly allocated into two groups of intervention and conventional treatment by balanced block randomization technique with 4 blocks.R software generated random numbers chains 1 to 6 until the desired sample size was achieved. Preparation of sequences of random allocation of cases and putting them in sealed envelopes (airtight) and numbered with a five-digit serial number were performed by a third person who was not involved in the study design.
Blinding (investigator's opinion)
Double blinded
Blinding description
The treatment group is given a glass of cactus opuntia syrup and the control group is replaced by a syrup of apple extract in a simmilar colour and same glass. Whoever is given cactus syrup and who is given placebo syrup is considered to be blind for the patient and the researcher. So the patients and the researcher are in no way aware of the division of the control and medication group and receive their treatment and care process according to the country's guideline treatment.
Placebo
Used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Alborz University of Medical Sciences
Street address
Emam Ali Hospital, Azimeyeh, Karaj
City
Karaj
Province
Alborz
Postal code
3154686695
Approval date
2020-05-01, 1399/02/12
Ethics committee reference number
IR.ABZUMS.REC.1399.024

Health conditions studied

1

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

Primary outcomes

1

Description
Improving lung function
Timepoint
Before starting the intervention, Up to 14 days daily after starting the intervention
Method of measurement
Measurement of venous blood Oxygen

Secondary outcomes

1

Description
Improving clinical performance
Timepoint
Before starting the intervention, Up to 14 days after starting the intervention
Method of measurement
Clinical symptoms include cough, shortness of breath, body aches, headaches, weakness, and body temperature are examined daily.

Intervention groups

1

Description
Intervention group: Cactus Opuntia is purchased from a reputable greenhouse in the form of cactus leaves and is extracted by the extraction machine in 250 cc bottles and is brought to the hospital daily for patients. In addition to standard treatment based on national guidelines, cactus extract 250 cc daily is given daily in the morning for 7 days and the patient is followed up for the next 7 days.
Category
Treatment - Other

2

Description
Control group: Control group: In this group, in addition to standard treatment based on national guidelines, 250 cc of aloe vera syrup is given daily.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Ali hospital
Full name of responsible person
Zeinab Siami
Street address
Emam Ali hospital, Azimeyeh, Karaj
City
Karaj
Province
Alborz
Postal code
3154686695
Phone
+98 26 3252 7576
Email
z.siami@abzums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mohammad Noorisepehr
Street address
Deputy of Research and Technology, Saffarian Alley, Golshahr
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3705
Email
Research@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Karaj University of Medical Sciences
Full name of responsible person
Zeinab Siami
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Emam Ali hospital, Azimieh, Karaj
City
Karaj
Province
Alborz
Postal code
3154686695
Phone
+98 26 3252 7576
Email
z.siami@abzums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Zeinab Siami
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Emam Ali hospital, Azimieh, Karaj
City
Karaj
Province
Alborz
Postal code
3154686695
Phone
+98 26 3252 7576
Fax
Email
z.siami@abzums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Zeinab Siami
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Emam Ali hospital, Azimieh, Karaj
City
Karaj
Province
Alborz
Postal code
3154686695
Phone
+98 26 3252 7576
Fax
Email
z.siami@abzums.ac.ir

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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Patient data will be published in average numbers not as a distinct ones.
When the data will become available and for how long
Access starts 6 months after printing results
To whom data/document is available
The data will be available to researchers working at academic and scientific institutions and industries
Under which criteria data/document could be used
No other conditions are allowed for the use of data and documentation
From where data/document is obtainable
z.siami@abzums.ac.ir
What processes are involved for a request to access data/document
The data will be sent via email no later than one month after the request.
Comments
Loading...