Protocol summary

Study aim
Evaluation the effect of black pepper extract and black seed and turmeric on inflammatory factors and acute phase lipid and protein profiles in patients with Covid - 19 hospitalized
Design
A clinical trial with a control group with parallel, double-blind, randomized, phase 3 groups on 60 patients will be randomized using randomized blocking method
Settings and conduct
all patients with Covid-19 in the age range of 20 to 70 years who are admitted to the covid-19 ward of Khatam al- Anbia Hospital in Shoushtar will be eligible to enter the study. The number of participants in each group is 30. Full explanations of the study are given and if they agree to enter the study, they will be given written consent. General characteristics questionnaire includes: age, sex, smoking, diet supplements and medications, history of disease and duration of illness and questions about taking antioxidant supplements. A placebo containing wheat flour is prepared in a similar way and in the same shape and color .The patients in the intervention group consume 3 grams of black pepper and turmeric extract daily in hard capsules (1 capsule of 500 mg after lunch and dinner).
Participants/Inclusion and exclusion criteria
At first, all patients with Covid-19 in the age range of 20 to 70 years who are admitted to the covid-19 ward of Khatam al-Anbia Hospital in Shoushtar will be eligible for inclusion in the study. Exclusion criteria include supplementation Less than 80% of the total is the change in the type and amount of drug used during the intervention and the unwillingness to continue cooperation in the study.
Intervention groups
Two intervention groups with herbal capsules and the control group with placebo
Main outcome variables
CBC,blood lipids(HDL، LDL , TG, CHOLESTROLE),BLOOD SUGER, PT, PTT, blood interleukin 6, D- DIMER, ALT, AST,ALP, BILLI TOTAL , DIRECT), hs-CRP,

General information

Reason for update
Acronym
طب سنتی ، درمان، کوید 19
IRCT registration information
IRCT registration number: IRCT20210804052068N1
Registration date: 2021-11-23, 1400/09/02
Registration timing: registered_while_recruiting

Last update: 2021-11-23, 1400/09/02
Update count: 0
Registration date
2021-11-23, 1400/09/02
Registrant information
Name
Sima Hashemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3622 8926
Email address
simahashemi8491@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-01-21, 1400/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of combined capsule black pepper ،sativa linn )black cumin) and Curcuma Longa on inflammation factors and lipid profiles and acute phase proteins in patients with covid-19 hospitalized
Public title
the effect of combined herbal capsule on covid-19 disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients admitted to covid-19 wards of the hospital positive pcr test Age range 20 to 70 years Willingness to participate in the study
Exclusion criteria:
The patient avoids taking the capsule changing the type and amount of medication taken during the intervention Any changes in treatment plan and disease conditions Chronic diseases such as diabetes, hypertension, cancer, obesity (body mass index above 30) History of drug and food allergies Transfer the patient to the intensive care unit عدم تمایل به ادامه همکاری در مطالعه
Age
From 20 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 30
More than 1 sample in each individual
Number of samples in each individual: 2
5 ml of blood is taken in the first and fifth days of hospitalization. Blood samples are immediately sent to the laboratory of Khatam Al-Anbia Hospital (PBUH), kept at room temperature for 30 to 45 minutes to clot and then centrifuged at 4 ° C for 15 minutes and its serum sample Is separated. Serum samples were stored at minus 80 ° C (38) and then the studied markers were measured by spectrophotometry and ELISA.
Randomization (investigator's opinion)
Randomized
Randomization description
To control the effect of confounding factors, individuals are matched in two groups in terms of age, sex, and body mass index. Purposeful sampling is performed among patients with 19 patients admitted to Khatam Al-Anbia Hospital in Shoushtar.In this way, in random selection of samples, blocking is used with the help of computer drive button, And the method of assigning individuals to the two groups studied is a random blocking method with quadruple blocks.The blocks are selected until they reach the desired volume (60 patients) based on a table of random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
All steps to be double-blind will be performed by a third party after the coding steps, which means that researchers providing care and patients will not have information on the complementary type until the end of the study. In order to further ensure that the selection bias does not occur after random allocation, the allocation conciliation method will be used by using unique two-digit codes for each person.
Placebo
Used
Assignment
Parallel
Other design features
-

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shushtar University of Medical Sciences
Street address
Rajaei St., Alhadi Hospital, Nursing Department Management Office
City
shoushtar
Province
Khouzestan
Postal code
6451684534
Approval date
2021-06-15, 1400/03/25
Ethics committee reference number
IR.SHOUSHTAR.REC.1400.002

Health conditions studied

1

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

Primary outcomes

1

Description
Age, history of disease, history of use of immunosuppressive drugs, sex, level of education, length of hospital stay, economic status, blood lipids, blood interleukins, hs-CRP
Timepoint
From the first of November 2021to the first of July 2022
Method of measurement
the studied markers are measured by spectrophotometric and ELISA methods.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients consuming herbal capsules of a combination of black pepper, black seed and turmeric
Category
Treatment - Drugs

2

Description
Control group: Patients taking placebo containing capsules filled with wheat flour
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Khatam al-Anbia Hospital in Shushtar
Full name of responsible person
sima hashemi
Street address
Shahid Rajaei crossroads-Alhadi Hospital,Director of Nursing Department
City
shoushtar
Province
Khouzestan
Postal code
6451684534
Phone
+98 61 3622 8926
Fax
+98 61 3622 8926
Email
simahashemi8491@gmail.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shooshtar University of Medical Sciences
Full name of responsible person
sima hashemi
Street address
Shahid Rajaei crossroads
City
shoushtar
Province
Khouzestan
Postal code
6451684534
Phone
+98 61 3622 8926
Fax
+98 61 3622 8926
Email
simahashemi8491@gmail.com
Grant name
Shushtar university of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shooshtar 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
Shooshtar University of Medical Sciences
Full name of responsible person
sima hashemi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
nursing
Street address
Shahid Rajaei Crossroads
City
shoushtar
Province
Khouzestan
Postal code
6451684534
Phone
+98 61 3622 8926
Email
simahashemi8491@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shooshtar University of Medical Sciences
Full name of responsible person
sima hashemi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Rajaei street , Alhadi hospital, Nursing Department Management Office
City
Shoushtar
Province
Khouzestan
Postal code
6451684534
Phone
+98 61 3622 8926
Email
simahashemi8491@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shooshtar University of Medical Sciences
Full name of responsible person
sima hashemi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Rajaei St., Alhadi Hospital, Nursing Department Management Office
City
shoushtar
Province
Khouzestan
Postal code
6451684534
Phone
+98 61 3622 8926
Email
simahashemi8491@gmail.com

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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