Protocol summary
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Study aim
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Preparation of two oral herbal remedies including decoction and capsule and evaluation of their efficacy in patients with COVID-19 via a randomized clinical trial.
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Design
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Randomized Concurrent Controlled Trial
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Settings and conduct
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68 patients are selected based on national guidelines for diagnosis and treatment of COVID-19 requiring hospitalization and drug treatment. Thirty-four patients receive routine treatment, and 34 receive herbal remedies (decoction every 8 hours and capsules every twelve hours) plus routine treatment for 2 weeks.To randomly assign the patients to two groups of treatment and placebo by a third person and using a computer program with simple randomization method, the random sample number is generated and each patient will be assigned a number.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
1. Patients with one or more of the following symptoms in addition to acute respiratory disease (ARI):
• RR> 30
• PO2 <93%
• Pulmonary infiltration in chest x-ray
2. Age range of 18 to 75 years in both genders
3. Patient not intubated.
4. Lack of any serious concomitant disease of the heart, brain, or lungs, metabolic disorders, and etc.
Exclusion criteria:
1. Pregnancy and lactation
2. Any history of allergy to any of the herbal product components
3. Inability to take a drug per-oral
4. Need for intubation
5. Any condition that precludes continuance of medical intervention based on the judgment of a physician.
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Intervention groups
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34 patients receive routine interventions according to the instructions of the Ministry of Health and 34 patients receive herbal treatment (decoction every 8 hours and capsule every 12 hours) with routine interventions based on the instructions of the Ministry of Health for 2 weeks.
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Main outcome variables
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The rate of radiologic improvement in chest x-ray or CT scan based on expert evaluation
General information
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Reason for update
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In the intervention section, examples of drug components were given, which according to the project executers, for perfect conformity with approved proposal and the ongoing project, components were completed with supplemented corrections.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180712040449N2
Registration date:
2020-04-01, 1399/01/13
Registration timing:
registered_while_recruiting
Last update:
2020-04-28, 1399/02/09
Update count:
1
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Registration date
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2020-04-01, 1399/01/13
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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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2020-03-23, 1399/01/04
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Expected recruitment end date
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2020-06-18, 1399/03/29
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Formulation and evaluation of their efficacy of herbal capsule and decoction in patients with COVID-19 via a randomized clinical trial.
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Public title
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Effect of oral multi-herbal preparation on COVID-19
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with one or more of the following symptoms in addition to acute respiratory disease (ARI):• RR> 30• PO2 <93%• Pulmonary infiltration in chest x-ray• Clinical judgment of a specialist
Age range of 18 to 75 years in both genders
Lack of any serious concomitant disease of the heart, brain, or lungs, metabolic disorders, and etc.
The patient’s ability and own will to fill out a personal consent form for inclusion in the study
Patient not intubated.
Exclusion criteria:
Pregnancy and lactation
Any history of allergy to any of the herbal product components
Inability to take a drug per-oral
Any condition that precludes continuance of medical intervention based on the judgment of a physician.
Need for intubation
Nausea and vomiting and oral intolerance
Resistant hypoxemia
Reduced level of consciousness
Hemodynamic instability
Hypercapnia - respiratory fatigue
Any manifestation of known side effects of any of the herbal product components
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Age
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From 18 years old to 75 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
68
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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To randomly assign the patients to two groups of treatment and placebo by a third person and using a computer program with simple randomization method, the random sample number is generated and each patient will be assigned a number.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not 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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2020-03-22, 1399/01/03
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Ethics committee reference number
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IR.TUMS.VCR.REC.1399.024
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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U07.1
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ICD-10 code description
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Covid-19
Primary outcomes
1
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Description
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O2 saturation percentage
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Timepoint
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Clinical examination and pulse oximetry at baseline, days 3, 6, 9, 12 and 14
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Method of measurement
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Pulse Oximeter
2
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Description
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Lung inflammation
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Timepoint
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CT scan at baseline, days 7 and 14
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Method of measurement
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CT scan
Intervention groups
1
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Description
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Intervention group: 34 patients receive herbal treatment including 150 ml of decoction (Matricaria chamomilla L., Zataria multiflora Boiss., Glycyrrhiza glabra L., Ziziphus jujuba Mill., Ficus carica L., Urtica dioica L., Althaea officinalis L., Hyssopus officinali L.) 3 times a day and capsule (Lyophilized powder from hydroalcoholic 70% extracts of Punica granatum L., Rheum palmatum L. and seed powder of Nigella sativa L.) 2 times a day with routine interventions based on the instructions of the Ministry of Health for 2 weeks.
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Category
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Treatment - Drugs
2
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Description
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Control group:34 patients receive routine interventions according to the instructions of the Ministry of Health for 2 weeks.
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Category
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Treatment - Drugs
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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Tehran 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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Yes - There is 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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Yes - There is a plan to make this available
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Title and more details about the data/document
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The documentation including the primary and secondary outcomes of patients that will be available
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When the data will become available and for how long
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From the start of the clinical study to one year after the completion of the clinical study
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To whom data/document is available
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If another researcher wants to perform a clinical study in this field and needs our information to do the study, the information will be provided with confidentiality. - If patients have side effects, and their doctors need the treatment information. -If a health authority's health policy requires our study information, then the information is provided with confidentiality.
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Under which criteria data/document could be used
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If the applicant is authenticated, his request will be discussed with other researchers involved in the study, and the result will be informed to him.
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From where data/document is obtainable
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Mehrdad Karimi
mehrdadkarimi@yahoo.com
0098 21 66976527
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What processes are involved for a request to access data/document
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At first, the applicants must send their request to the correspond author of the study, whose email address is on the IRCT site, and after verifying the applicant's identity, including one of the upon items, the correspond author requests information of the researchers who are present in the study and is sent to applicants. This period, after the applicant's authentication, will take about two weeks.
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Comments
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