Assessment of efficacy of the Indigenous poly herbal drug “Desandun Kalka” against mild symptomatic patients with SARS-CoV- 2 infection - A randomized clinical trial

Assessment of the efficacy of the indigenous polyherbal drug “Desandun Kalka” against SARS-CoV- 2 infection

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2021/005

Enrollment

Unknown

Registered

2021-02-28

Start date

2021-03-10

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

SARS-CoV- 2 infection

Interventions

1. Study setting: “National Institute of Infectious Diseases” (NIID) and University of Sri Jayewardenepura (USJP) will be the research study places. 2. Randomization method: Simple random sampling wi

Dolichos biflous Linn. - Kollu Glycyrrhiza glabra Linn. – Welmee Acorus calamus Linn. ` - Wadakaha Ptrocarpus santalinus Linn. - Rathandun Santalum album Linn. - Suduhandun Rock salt - Savindalunu

Eligibility

Inclusion criteria

Inclusion criteria: * Age > 18 years • Both male and female * PCR positive for SARS-CoV- 2 * The patient clinically assessed and categorized according to the tool published by Min. of Health, Sri Lanka, “Provisional Guidelines for Clinical Management of COVID-19, (March 2020)” as patients with mild symptoms of SARS COVID-19 infection and defined as below: - Respiratory Rate (RR/min) 12 – 20 - Heart Rate (HR/min) 94

Exclusion criteria

Exclusion criteria: * Pregnant and breast feeding mothers * Those with severe and moderate illness (COVID 19) * Chronic Liver Cell Disease (CLCD), * Chronic Kidney Disease (CKD) * Those who are unable to take the drug orally

Design outcomes

Primary

Measure	Time frame
A more than 50% reduction in the duration of illness (cough, fever, sore throat & anosmia) - defined below [at baseline, day 7, and day 10 from the time of treatment begins] Number of days taken for the patient to be afebrile for 72 hours [at baseline, day 7, and day 10 from the time treatment begins] Number of days taken for a more than 50% reduction in cough by clinical assessment [at baseline, day 7, and day 10 from the time treatment begins] Number of days taken for a more than 50% reduction of sore throat by clinical assessment [at baseline, day 7, and day 10 from the time treatment begins] Number of days taken for a more than 50% reduction in resolution of anosmia by clinical assessment [at baseline, day 7, and day 10 from the time treatment begins]	—

Measure

Time frame

A more than 50% reduction in the duration of illness (cough, fever, sore throat & anosmia) - defined below [at baseline, day 7, and day 10 from the time of treatment begins] Number of days taken for the patient to be afebrile for 72 hours [at baseline, day 7, and day 10 from the time treatment begins] Number of days taken for a more than 50% reduction in cough by clinical assessment [at baseline, day 7, and day 10 from the time treatment begins] Number of days taken for a more than 50% reduction of sore throat by clinical assessment [at baseline, day 7, and day 10 from the time treatment begins] Number of days taken for a more than 50% reduction in resolution of anosmia by clinical assessment [at baseline, day 7, and day 10 from the time treatment begins]

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Secondary

Measure	Time frame
Clinical improvement using the Ordinal Scale for Clinical Improvement COVID 19 Therapeutic Trial Synopsis, February 18, 2020, Geneva, Switzerland (WHO – Outcome scale, World Health Organization 2020) [Day 1, day 7 and day 10 from the time treatment begins] Proportion of patients with a negative PCR & cycle threshold (Ct) value of over 24 (negative RT-qPCR) with positive antibody response [Day 7 and day 10 from the time treatment begins] Proportion of patients with 50% reduction in lymphocytopenia by assessing the full blood count [Day 7 and day 10 from the time treatment begins] Proportion of patients with 50% reduction in degree of inflammation by evaluation of inflammatory markers (C-Reactive Protein, ESR) as per standards [ESR 1-13mm/hr for males & 1-20 mm/hr for females and CRP measured as less than 10 mg /l] [Day 7 and day 10 from the time treatment begins] Proportion of patients with any adverse effects of DK assessed by carrying out FBC, liver function tests (,AST, ALT) and renal function tests (GFR, Serum creatinine) [Day 7, day 10, and day 28 from the time treatment begins] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [.] [] [] [ .] [ ] [ ] [] [ ] [ ] [ ] [ ] [ ] [ ] [] [] [ ] [] [ ] [ ] [ ] [ ] [] [ ] [] [] [ ] []	—

Measure

Time frame

Clinical improvement using the Ordinal Scale for Clinical Improvement COVID 19 Therapeutic Trial Synopsis, February 18, 2020, Geneva, Switzerland (WHO – Outcome scale, World Health Organization 2020) [Day 1, day 7 and day 10 from the time treatment begins] Proportion of patients with a negative PCR & cycle threshold (Ct) value of over 24 (negative RT-qPCR) with positive antibody response [Day 7 and day 10 from the time treatment begins] Proportion of patients with 50% reduction in lymphocytopenia by assessing the full blood count [Day 7 and day 10 from the time treatment begins] Proportion of patients with 50% reduction in degree of inflammation by evaluation of inflammatory markers (C-Reactive Protein, ESR) as per standards [ESR 1-13mm/hr for males & 1-20 mm/hr for females and CRP measured as less than 10 mg /l] [Day 7 and day 10 from the time treatment begins] Proportion of patients with any adverse effects of DK assessed by carrying out FBC, liver function tests (,AST, ALT) and renal function tests (GFR, Serum creatinine) [Day 7, day 10, and day 28 from the time treatment begins] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [.] [] [] [ .] [ ] [ ] [] [ ] [ ] [ ] [ ] [ ] [ ] [] [] [ ] [] [ ] [ ] [ ] [ ] [] [ ] [] [] [ ] []

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Countries

Sri Lanka

Contacts

Public ContactDr. Rameeladevi Thatparan

Medical Officer

rameela10@gmail.com0112850333

Outcome results

None listed

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