Randomized double blind controlled trial to assess the safety and efficacy of three investigational herbal preparations (nut meg based preparation, sudarshana churna, coriandum based preparation) for the treatment of patients with COVID-19

Randomized double blind placebo controlled trial of the safety and efficacy of investigational herbal preparations for the treatment of patients with COVID-19

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2021/008

Enrollment

Unknown

Registered

2021-03-15

Start date

2021-03-15

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

COVID 19

Interventions

This study will be conducted at the Covid Centre, Base Hospital Theldeniya, Sri Lanka. Patients who fulfill the inclusion criteria will be randomized into four groups using computer-generated random n

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients who understands and agrees to comply with planned study procedures. 3. Patients who agree to the collection of nasopharyngeal swabs and venous blood per protocol. 4. Male >18 years or non-pregnant female adult >18 years of age at the time of enrolement. 5. Has a laboratory confirmed SARS-CoV-2 infection as determined by positive PCR done within 72 hrs, with a quantitative PCR cycle threshold (qPCR Ct value ) which is less than 25 and a positive Rapid antigen testing (RAT) performed at the point of admission.

Exclusion criteria

Exclusion criteria: 1. Known patients with chronic liver disease and kidney disease 2. Alanine amino transferase (ALT) or Aspartate amino transferase (AST) or Serum creatinine> 2 times the upper limit of normal. 3. Pregnancy or breast feeding. 4. Anticipated transfer to another hospital which is not a study site within 72 hours. 5. Allergy to any study medication 6. Treatment with another investigational drug or other intervention 7. Patients who are on warfarin, glucocorticoids and other immuno-suppressive medications or anti-cancer medications 8. Patients with known substance abuse

Design outcomes

Primary

Measure	Time frame
1. Percentage reduction of viral burden as measured by quantitative PCR cycle threshold values and negative percentage of rapid antigen testing (RAT ) of naso pharyngeal swabs. [D4 and D7 from the starting day of intervention] 2. Clinical improvement as assessed by 10 point ordinal scale -Mean change in the clinical status 10 point ordinal scale from Day 1 to Days 4, and 7 (Ref Ramdesivir for treament of COVID 19 N Engl J Med 2020; 383:1813-1826 ,DOI: 10.1056/NEJMoa2007764) [D4 and D7 from the starting day of intervention] 3. Clinical improvement and clinical progression Clinical improvement as assessed by % change for National Early Warning Score (NEWS): Change from Day 1 to Days 4 and 7 in NEWS. Clinical progression using the WHO ordinal outcome scale – (WHO Working Group on the Clinical characterizations and Management of COVID-19 infection. A minimal common outcome measure set for COVID-19 clinical research. Lancet Infect Dis 2020. Published Online June 12, 2020. https://doi.org /10.1016/S1473-3099(20)30483-7) [D4 and D7 from the starting day of intervention] 4. Percentage Improvement in white cell count, ALT, and AST, creatinine, CRP (C reactive protein), D Dimers, ferritin over time from D1 through D4 to D7 [D4 and D7 from the starting day of intervention] [ ] [ ] [ ] [] [ ] [] [] [ ] [ ] [ ] [] [ ] [] [ ] [] [] [] [ ] [] [ ] [] [] []	—

Measure

Time frame

1. Percentage reduction of viral burden as measured by quantitative PCR cycle threshold values and negative percentage of rapid antigen testing (RAT ) of naso pharyngeal swabs. [D4 and D7 from the starting day of intervention] 2. Clinical improvement as assessed by 10 point ordinal scale -Mean change in the clinical status 10 point ordinal scale from Day 1 to Days 4, and 7 (Ref Ramdesivir for treament of COVID 19 N Engl J Med 2020; 383:1813-1826 ,DOI: 10.1056/NEJMoa2007764) [D4 and D7 from the starting day of intervention] 3. Clinical improvement and clinical progression Clinical improvement as assessed by % change for National Early Warning Score (NEWS): Change from Day 1 to Days 4 and 7 in NEWS. Clinical progression using the WHO ordinal outcome scale – (WHO Working Group on the Clinical characterizations and Management of COVID-19 infection. A minimal common outcome measure set for COVID-19 clinical research. Lancet Infect Dis 2020. Published Online June 12, 2020. https://doi.org /10.1016/S1473-3099(20)30483-7) [D4 and D7 from the starting day of intervention] 4. Percentage Improvement in white cell count, ALT, and AST, creatinine, CRP (C reactive protein), D Dimers, ferritin over time from D1 through D4 to D7 [D4 and D7 from the starting day of intervention] [ ] [ ] [ ] [] [ ] [] [] [ ] [ ] [ ] [] [ ] [] [ ] [] [] [] [ ] [] [ ] [] [] []

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Secondary

Measure	Time frame
Adverse reaction profile, As assessed clinically on a daily basis from D1 to D7 Clinical assessment will be done using a symptom questionnaire. (Ref Ramdesivir for threament of COVID 19 N Engl J Med 2020; 383:1813-1826 ,DOI: 10.1056/NEJMoa2007764) [From D4 and D7 from starting the intervention] Adverse reaction profile on biochemical assessment on D4 and D7 (compared with baseline on D1) Percentage Change in white cell count, haemoglobin, platelets, creatinine, glucose, total bilirubin, ALT, and AST, creatinine, CRP, D Dimers, ferritin over time from D1 through D4 to D7 [From D4 and D7 from starting the intervention] Duration of hospitalization (days). [Assessed at D7, D14, D28 from the day of intervention] Proportion of patients with positive antibody response assessed using COVID antibody testing [Assessed at D7 from the day of intervention] Mortality (if any) • 07-day mortality and cause of death • 28-day mortality and cause of death [Assessed at D7 and D28 from the day of intervention] [] [ ] [ ] [ ] [ ] [] [ ] [] [] [ ] [ ] [ ] [] [ ] [ ]	—

Measure

Time frame

Adverse reaction profile, As assessed clinically on a daily basis from D1 to D7 Clinical assessment will be done using a symptom questionnaire. (Ref Ramdesivir for threament of COVID 19 N Engl J Med 2020; 383:1813-1826 ,DOI: 10.1056/NEJMoa2007764) [From D4 and D7 from starting the intervention] Adverse reaction profile on biochemical assessment on D4 and D7 (compared with baseline on D1) Percentage Change in white cell count, haemoglobin, platelets, creatinine, glucose, total bilirubin, ALT, and AST, creatinine, CRP, D Dimers, ferritin over time from D1 through D4 to D7 [From D4 and D7 from starting the intervention] Duration of hospitalization (days). [Assessed at D7, D14, D28 from the day of intervention] Proportion of patients with positive antibody response assessed using COVID antibody testing [Assessed at D7 from the day of intervention] Mortality (if any) • 07-day mortality and cause of death • 28-day mortality and cause of death [Assessed at D7 and D28 from the day of intervention] [] [ ] [ ] [ ] [ ] [] [ ] [] [] [ ] [ ] [ ] [] [ ] [ ]

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Countries

Sri Lanka

Contacts

Public ContactH.M.T.W.seneviratne

Senior lecturer

thilanka.medi@gmail.com94 -812396386

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026