Effects of Shilajit (Momiai) on COVID-19 disease

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210508051225N1

Enrollment

110

Registered

2021-06-14

Start date

2022-05-22

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19. COVID-19, virus identified

Interventions

Intervention 1: 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 COV

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Severity of clinical presentations of COVID-19. Timepoint: At the beginning of the study (before intervention initiation) and 7, 14, and 28 days after Shilajit use. Method of measurement: 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.;Oxygen saturation:fraction of inspired oxygen ratio (SPO2:FiO2). Timepoint: At the beginning of the study (before intervention initiation) and 7, 14, and 28 days after Shilajit use. Method of measurement: Pulse oxymeter.;Axillary temperature. Timepoint: At the beginning of the study (before intervention initiation) and daily afterwards. Method of measurement: mercury thermometer.;Incidence of respiratory distress. Timepoint: At the beginning of the study (before intervention initiation) and anytime during the study period. Method of measurement: Patient records data/Physician examination.;Ventilation need. Timepoint: At the beginning of the study (before intervention initiation) and anytime during the study period. Method of measurement: Patient records data/Physician examination.;Intensive Care Unit admission. Timepoint: At the beginning of the study (before intervention initiation) and anytime during the study period. Method of measurement: Patient records data/Physician examination.;Duration of Intensive Care Unit admissio	—

Measure

Time frame

Severity of clinical presentations of COVID-19. Timepoint: At the beginning of the study (before intervention initiation) and 7, 14, and 28 days after Shilajit use. Method of measurement: 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.;Oxygen saturation:fraction of inspired oxygen ratio (SPO2:FiO2). Timepoint: At the beginning of the study (before intervention initiation) and 7, 14, and 28 days after Shilajit use. Method of measurement: Pulse oxymeter.;Axillary temperature. Timepoint: At the beginning of the study (before intervention initiation) and daily afterwards. Method of measurement: mercury thermometer.;Incidence of respiratory distress. Timepoint: At the beginning of the study (before intervention initiation) and anytime during the study period. Method of measurement: Patient records data/Physician examination.;Ventilation need. Timepoint: At the beginning of the study (before intervention initiation) and anytime during the study period. Method of measurement: Patient records data/Physician examination.;Intensive Care Unit admission. Timepoint: At the beginning of the study (before intervention initiation) and anytime during the study period. Method of measurement: Patient records data/Physician examination.;Duration of Intensive Care Unit admissio

—

Secondary

Measure	Time frame
All-cause mortality. Timepoint: any time during the study period. Method of measurement: Incidence of death due to any cause during the study period.;Hospital admission duration. Timepoint: during the study period. Method of measurement: Days from admission to discharge or decease.;Intensive Care Unit admission duration. Timepoint: during the study period. Method of measurement: Days from admission in the Intensive care unit to discharge or decease.;Intensive Care Unit admission. Timepoint: During the study period. Method of measurement: Incidence of Intensive Care Unit admission.;Time to Intensive Care Unit admission. Timepoint: During the study period. Method of measurement: Days from hospital admission to Intensive Care Unit referral.;Ventilation requirement. Timepoint: During the study period. Method of measurement: Incidence of ventilation requirement.;Time to ventilation. Timepoint: During the study period. Method of measurement: Days from admission to initiation of mechanical ventilation.	—

Measure

Time frame

All-cause mortality. Timepoint: any time during the study period. Method of measurement: Incidence of death due to any cause during the study period.;Hospital admission duration. Timepoint: during the study period. Method of measurement: Days from admission to discharge or decease.;Intensive Care Unit admission duration. Timepoint: during the study period. Method of measurement: Days from admission in the Intensive care unit to discharge or decease.;Intensive Care Unit admission. Timepoint: During the study period. Method of measurement: Incidence of Intensive Care Unit admission.;Time to Intensive Care Unit admission. Timepoint: During the study period. Method of measurement: Days from hospital admission to Intensive Care Unit referral.;Ventilation requirement. Timepoint: During the study period. Method of measurement: Incidence of ventilation requirement.;Time to ventilation. Timepoint: During the study period. Method of measurement: Days from admission to initiation of mechanical ventilation.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNarjes Bahri

Gonabad University of Medical Sciences

nargesbahri@yahoo.com+98 51 5722 3028

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026