Effectiveness of enriched garlic extract in patients with COVID-19

Evaluation of the efficacy of Gallecina® oral capsules, a hydrogen sulfide prodrug, as an adjuvant therapy in hospitalized patients with COVID-19: a randomized placebo-controlled triple-blind clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20201111049347N1

Enrollment

248

Registered

2021-04-16

Start date

2021-04-21

Completion date

Unknown

Last updated

2021-05-26

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

Conditions

Covid-19. Coronavirus infection, unspecified

Interventions

Intervention 1: Intervention group: Based on the patient's clinical status, and treatment criteria, the following antiviral and anti-inflammatory drugs may be prescribed to the patient: Interferon bet

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Hospitalized patients with definite diagnosis of SARS-CoV-2 infection based on PCR or detection of pulmonary involvement on CT scan. Hospitalized patients aged 18 to 65 years old

Exclusion criteria

Exclusion criteria: History of garlic allergy and garlic-derived products Pregnancy and lactation period Low patient pressure at the beginning of the study (below 120/80) Malignancy, Immune deficiency, Alzheimer's, Multiple organ failure, Encephalopathy

Design outcomes

Primary

Measure	Time frame
The time to recovery, defined as the from the time of randomization and start of treatment to the first day of recovery: not hospitalized, hospitalized with not requiring supplemental oxygen and/or no longer requiring ongoing medical care (used if hospitalization was extended for infection-control reasons). Timepoint: From the time of randomization. Method of measurement: Number of days.;Time to normalize fever (in hours): From the time of randomization and start of treatment, to be normalized fever. The criteria for normalization is: Fever - =36.9°C or -axilla, =37.2 °C oral. Timepoint: every 6 hour. Method of measurement: Body temperature.;Time to improve shortness of breath (in hours): From the time of randomization and start of treatment, to be normalized respiratory rate. The criteria for normalization is: Respiratory rate - =24/minute on room air. Timepoint: every 6 hour. Method of measurement: Respiratory rate.;Time to normalize oxygen saturation (in hours): From the time of randomization and start of treatment, to be normalized oxygen saturation. The criteria for normalization is: Oxygen saturation - >94% on room air. Timepoint: every 6 hour. Method of measurement: O2 saturation measurement.;Time to improve cough (in hours): From the time of randomization and start of treatment, to be improved cough. The criteria for normalization is: Cough - mild or absent on a patient-reported scale of severe, moderate, mild, absent. Timepoint: every 6 hour. Method of measurement: Cough rate.;Number of patients with changes in oxygen delivery status. The categories are as follows: 1. hospitalized, not requiring supplemental oxygen and no longer requiring ongoing medical care (used if hospitalization was extended for infection-control reasons); 2. hospitalized, not requiring supplemental oxygen but requiring ongoing medical care (Covid-19–related or other medical conditions); 3. hospitalized, requiring any supplemental oxygen; 4. hospitalized, requiring noninvasive ventil	—

Measure

Time frame

The time to recovery, defined as the from the time of randomization and start of treatment to the first day of recovery: not hospitalized, hospitalized with not requiring supplemental oxygen and/or no longer requiring ongoing medical care (used if hospitalization was extended for infection-control reasons). Timepoint: From the time of randomization. Method of measurement: Number of days.;Time to normalize fever (in hours): From the time of randomization and start of treatment, to be normalized fever. The criteria for normalization is: Fever - =36.9°C or -axilla, =37.2 °C oral. Timepoint: every 6 hour. Method of measurement: Body temperature.;Time to improve shortness of breath (in hours): From the time of randomization and start of treatment, to be normalized respiratory rate. The criteria for normalization is: Respiratory rate - =24/minute on room air. Timepoint: every 6 hour. Method of measurement: Respiratory rate.;Time to normalize oxygen saturation (in hours): From the time of randomization and start of treatment, to be normalized oxygen saturation. The criteria for normalization is: Oxygen saturation - >94% on room air. Timepoint: every 6 hour. Method of measurement: O2 saturation measurement.;Time to improve cough (in hours): From the time of randomization and start of treatment, to be improved cough. The criteria for normalization is: Cough - mild or absent on a patient-reported scale of severe, moderate, mild, absent. Timepoint: every 6 hour. Method of measurement: Cough rate.;Number of patients with changes in oxygen delivery status. The categories are as follows: 1. hospitalized, not requiring supplemental oxygen and no longer requiring ongoing medical care (used if hospitalization was extended for infection-control reasons); 2. hospitalized, not requiring supplemental oxygen but requiring ongoing medical care (Covid-19–related or other medical conditions); 3. hospitalized, requiring any supplemental oxygen; 4. hospitalized, requiring noninvasive ventil

—

Secondary

Measure	Time frame
Incidence of adverse effects: Acute respiratory failure, hypotension, viral pneumonia, acute renal failure, anemia, decreased hemoglobin, decreased GFR, increased creatinine, hyper or hypoglycemia, increased LFT. Timepoint: End of the study. Method of measurement: Incidence of the adverse effect.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Sina Rezaei

Samisaz Pharmaceutical Co.

sina-rezaei@samisaz.com+98 51 3541 3385

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 11, 2026