Protocol summary
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Study aim
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Identifying effects of Shilajit (Mumiai) on clinical course and outcomes of COVID-19 disease
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Design
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Phase 3 parallel-group triple-blind randomized controlled trial on 110 patients.
Randomization will be done using the permuted block randomization approach with variable sizes (2 and 4).
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Settings and conduct
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Study location: COVID ward of the Bohlool Gonabadi hospital, Gonabad city;
Study population: All patients with a moderate form of COVID-19 disease who are refered to Allameh Bohlool Gonabadi Hospital.
Type of blinding: Triple-blinded;
Blinding process: Blinding will be performed using capsules with the same shape and color as the capsules in the intervention group. Therefore, patient, clinician, and enumerator will be blinded about the content of the capsules and type of treatment. Type of treatment will be determined as A and B for the analyst; therefore, he will be unaware of the nature of the treatment.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Diagnosed moderate COVID-19 disease (based on the World Health organization laboratory and clinical criteria); Receiving standard medication for moderate disease based on COVID-19 management protocols; Age between 18 and 75 years old; Signing the informed consent form.
Non-inclusion criteria:
Pregnancy or lactation; Immune suppression conditions; History of chronic pulmonary diseases; Severe kidney failure, liver failure, heart failure; underlying diseases (diabetes and hypertension).
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Intervention groups
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Participants in the intervention group will receive two 500mg Shilajit capsules per day for 2 weeks and the control group will also receive placebo capsules for two weeks.
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Main outcome variables
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Clinical improvement up to 14 days after treatment; Cough; Headache; Sore throat; Chills; Smell disorder; Myalgia; Axillary Temperature; SPO2: FiO2 ratio.
General information
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Reason for update
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Updating the sampling actual date and actual sample size.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210508051225N1
Registration date:
2021-06-14, 1400/03/24
Registration timing:
prospective
Last update:
2026-01-06, 1404/10/16
Update count:
1
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Registration date
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2021-06-14, 1400/03/24
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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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2022-05-22, 1401/03/01
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Expected recruitment end date
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2024-02-20, 1402/12/01
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Actual recruitment start date
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2022-03-08, 1400/12/17
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Actual recruitment end date
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2024-12-20, 1403/09/30
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Trial completion date
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2024-12-20, 1403/09/30
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Scientific title
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Comparison of the effects of Shilajit (Momiai) with placebo on clinical course, severity indices, admission duration and mortality rate in patients with moderate Coronavirus disease 2019 (COVID-19): A triple -blind randomized controlled trial
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Public title
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Effects of Shilajit (Momiai) on COVID-19 disease
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Diagnosis of moderate COVID-19 disease (based on the World Health Organization laboratory and clinical criteria)
Receiving standard and routine medications for moderate COVID-19 based on management protocols for COVID-19
age between 18 and 75 years old
signing the written informed consent form
Exclusion criteria:
Pregnancy
Lactation
Immune deficiency conditions (receiving chemotherapy, organ or bone marrow transplantation, autoimmune diseases)
History of chronic pulmonary disease
Participating or being registered for other trials
Severe renal failure (GFR< 30ml/min)
Liver failure
Heart failure (EF<40%)
History underlying diseases including diabetes and hypertension
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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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- Participant
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
110
Actual sample size reached:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization will be done using the permuted block randomization approach with variable sizes of 2 and 4. The analyzer will use online randomization website to generate the randomization list. The allocation randomization will also be concealed using opaque sealed envelopes with random sequences.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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Capsules with shape and color similar to the intervention group capsules will be used for blinding. Patients, therapist physician, enumerator and statistician will be blinded regarding the content of the capsules. Type of treatment will be determined as A and B for the analyst; therefore, he will be unaware of the nature of the treatment.
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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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none
Ethics committees
1
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Ethics committee
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Approval date
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2021-05-03, 1400/02/13
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Ethics committee reference number
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IR.GMU.REC.1400.012
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, virus identified
Primary outcomes
1
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Description
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Severity of clinical presentations of COVID-19
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Timepoint
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At the beginning of the study (before intervention initiation) and 7, 14, and 28 days after Shilajit use
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Method of measurement
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The criteria proposed by the World Health Organization will be used to determine COVID-19 severity and to assess the changes in disease severity during the study. Based on the criteria disease severity is defined based on a score between 0 and 8 as follows: (0) no clinical or virologic sign of infection (1) no limitation in activity (2) limitation in activity (3) hospital admission without oxygen therapy (4) hospital admission with oxygen therapy with mask or nasal cannula (5) hospital admission with non-invasive oxygen therapy or high flow oxygen (6) hospital admission with intubation or mechanical ventilation (7) hospital admission with supported ventilation including extracorporeal membrane oxygenation, vasopressors, or renal replacement therapy (8) death
2
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Description
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Oxygen saturation:fraction of inspired oxygen ratio (SPO2:FiO2)
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Timepoint
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At the beginning of the study (before intervention initiation) and 7, 14, and 28 days after Shilajit use
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Method of measurement
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Pulse oxymeter
3
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Description
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Axillary temperature
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Timepoint
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At the beginning of the study (before intervention initiation) and daily afterwards
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Method of measurement
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mercury thermometer
4
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Description
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Incidence of respiratory distress
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Timepoint
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At the beginning of the study (before intervention initiation) and anytime during the study period
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Method of measurement
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Patient records data/Physician examination
5
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Description
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Ventilation need
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Timepoint
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At the beginning of the study (before intervention initiation) and anytime during the study period
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Method of measurement
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Patient records data/Physician examination
6
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Description
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Intensive Care Unit admission
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Timepoint
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At the beginning of the study (before intervention initiation) and anytime during the study period
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Method of measurement
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Patient records data/Physician examination
7
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Description
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Duration of Intensive Care Unit admission
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Timepoint
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anytime during the study period
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Method of measurement
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Patient records data/Physician examination
8
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Description
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Time of death
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Timepoint
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anytime during the study period
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Method of measurement
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Patient records data/Physician examination
9
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Description
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Respiratory rate
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Timepoint
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At the beginning of the study (before intervention initiation) and daily afterwards
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Method of measurement
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Patient records data/Physician examination
Secondary outcomes
1
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Description
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All-cause mortality
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Timepoint
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any time during the study period
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Method of measurement
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Incidence of death due to any cause during the study period
2
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Description
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Hospital admission duration
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Timepoint
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during the study period
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Method of measurement
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Days from admission to discharge or decease
3
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Description
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Intensive Care Unit admission duration
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Timepoint
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during the study period
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Method of measurement
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Days from admission in the Intensive care unit to discharge or decease
4
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Description
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Intensive Care Unit admission
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Timepoint
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During the study period
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Method of measurement
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Incidence of Intensive Care Unit admission
5
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Description
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Time to Intensive Care Unit admission
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Timepoint
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During the study period
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Method of measurement
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Days from hospital admission to Intensive Care Unit referral
6
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Description
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Ventilation requirement
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Timepoint
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During the study period
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Method of measurement
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Incidence of ventilation requirement
7
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Description
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Time to ventilation
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Timepoint
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During the study period
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Method of measurement
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Days from admission to initiation of mechanical ventilation
Intervention groups
1
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Description
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Intervention group: The intervention group will receive two 500mg Shilajit capsules per day for two weeks. Intervention group will also receive medical treatments based on moderate COVID-19 treatment protocols.
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Category
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Treatment - Drugs
2
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Description
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Control group: The control group will receive two placebo capsules per day for two weeks. Control group will also receive medical treatments based on moderate COVID-19 treatment protocols.
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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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A-10-1269-11
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Gonabad 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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available