Protocol summary
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Study aim
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The effect of Trehala Manna on inflammatory biomarkers and clinical symptoms in covid-19 patients.
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Design
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A double blinded, parallel, randomized controlled clinical trial
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Settings and conduct
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Generation of the allocation sequence will be implemented by second investigator of study and enrollment of participants, and assignment of participants to intervention or control group will be done by the first investigator. This study will be implemented in Imam Reza Hospital (501AJA). Researcher, patients and data analysts will be blinded.
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Participants/Inclusion and exclusion criteria
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Age between 18-65
Written informed consent
Covid-19 patients (PCR positive test or clinical symptoms such as fever > 38, respiratory rate ≥ 24, dry cough, myalgia, asthenia, anosmia, and or anorexia
Admission to general corvid-19 unit in hospital
Patients who estimate that reside in hospital at least 7 days.
Non ICU patients
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Intervention groups
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Intervention: 2 sachets of Trehala Manna q12h (two times/day)
Placebo: 2 sachets of Maltodextrin q12h (two times/day)
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Main outcome variables
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C- reactive protein as an inflammatory biomarker
General information
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Reason for update
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The change in the spread of the COVID-19 disease following the waves of the pandemic caused a change in the expected date for the start of patient recruitment, and the study was carried out a few months after registration.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20211029052904N1
Registration date:
2021-12-30, 1400/10/09
Registration timing:
prospective
Last update:
2023-12-20, 1402/09/29
Update count:
2
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Registration date
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2021-12-30, 1400/10/09
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-12-06, 1400/09/15
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Expected recruitment end date
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2022-02-04, 1400/11/15
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Actual recruitment start date
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2022-05-01, 1401/02/11
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Actual recruitment end date
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2022-10-03, 1401/07/11
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Trial completion date
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2022-10-03, 1401/07/11
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Scientific title
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The effects of Trehala Manna (Shekar Tighal) on inflammatory and biochemistry biomarkers, and clinical outcomes in Covid-19 patients; A randomized double-blind placebo-controlled trial
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Public title
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The effects of Skekar Tighal on covid-19
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age between 18-65
Written informed consent
Covid-19 patients (PCR positive test or clinical symptoms such as fever > 38, respiratory rate ≥ 24, dry cough, myalgia, asthenia, anosmia, and or anorexia
Admission to general corvid-19 unit in hospital
Patients who estimate that reside in hospital at least 7 days.
Non ICU patients
Exclusion criteria:
Did not write informed consent
Pregnancy and lactation
Smoking
Usage of other herbal medicine
Hypertension (definition by ACC/AHA SBP/DBP ≥ 130/80)
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
60
Actual sample size reached:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Each patient will be recruited into intervention or control group using a valid random number making website: https://www.sealedenvelope.com/simple-randomiser/v1/lists. Eligible patients will be randomly allocated in a ratio of 1:1 to receive intervention or placebo with a block size of four.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The sealed and opaque envelopes prepared by a blinded herbal pharmacologist along with similar sachets that only varied in label (A or B) containing Trehala Manna or placebo. These are provided to the first investigator without specifying which package is the intervention or the placebo. The content of envelope determines A or B. After implementing statistical analysis, we will open envelopes to reveal labels.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-12-22, 1400/10/01
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Ethics committee reference number
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IR.AJAUMS.REC.1400.253
Health conditions studied
1
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Description of health condition studied
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Covid-19
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ICD-10 code
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J12.81
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ICD-10 code description
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Pneumonia due to SARS-associated coronavirus
Primary outcomes
1
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Description
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C reactive protein
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Timepoint
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At baseline (day 0) and end of the study (day 8)
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Method of measurement
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ELISA commercial diagnostic kit
2
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Description
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Assess the severity of cough
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Timepoint
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At baseline (day 0) and end of the study (day 8)
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Method of measurement
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Visual Analogue Scale
3
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Description
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Alanine transaminase
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Timepoint
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At baseline (day 0) and end of the study (day 8)
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Method of measurement
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Spectrophotometry
4
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Description
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Aspartate transaminase
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Timepoint
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At baseline (day 0) and end of the study (day 8)
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Method of measurement
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Spectrophotometry
Secondary outcomes
1
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Description
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Hospitalization days
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Timepoint
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Continuous
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Method of measurement
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Discharge day minus first day
Intervention groups
1
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Description
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Intervention group: 2 sachets of Trehala manna (refined Shekar Tighal) daily, 5 grams per sachet (a total of 10 grams per day in the form of a drink solution) for 7 days. In addition to the usual treatment protocols for patients.
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Category
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Treatment - Other
2
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Description
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Control group: 2 sachets of Maltodextrin daily (each sachet contains 5 grams and a total of 10 grams as a drink solution). In addition to the usual treatment protocols for patients.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Artesh University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Information about the study will be published after the nonidentifying individuals and when the project is completed.
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When the data will become available and for how long
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6 months after final manuscript
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To whom data/document is available
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Only for researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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For further analysis
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From where data/document is obtainable
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Mahdi keshani Mahdikeshani1@yahoo.com
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What processes are involved for a request to access data/document
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After reviewing the request and full transparency about the purposes of using the data, the data will be provided.
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Comments
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