Home » Trials » SLCTR/2021/005
Assessment of the efficacy of the indigenous polyherbal drug “Desandun Kalka” against SARS-CoV- 2 infection
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SLCTR Registration Number
SLCTR/2021/005
Date of Registration
The date of last modification
Mar 01, 2021
Scientific Title of Trial
Assessment of the efficacy of the indigenous polyherbal drug “Desandun Kalka” against SARS-CoV- 2 infection
Public Title of Trial
Assessment of efficacy of the Indigenous poly herbal drug “Desandun Kalka” against mild symptomatic patients with SARS-CoV- 2 infection - A randomized clinical trial
Disease or Health Condition(s) Studied
SARS-CoV- 2 infection
Scientific Acronym
ASDEK-COV2
Public Acronym
ASDEK-COV2
Brief title
Poly herbal formula for treatment of patients with COVID -19
Universal Trial Number
U1111-1264-9556
Any other number(s) assigned to the trial and issuing authority
FMS/USJP ERC/ COVID 15/20
What is the research question being addressed?
Is the polyherbal preparation, "Desandun kalka" efficacious in reducing the clinical symptoms and viral shedding for mild symptomatic patients with COVID-19 infection?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 2
Intervention(s) planned
Study setting: “National Institute of Infectious Diseases” (NIID) and University of Sri Jayewardenepura (USJP) will be the research study places.
Randomization method: Simple random sampling will be used to select the patients by electronic randomization (random e-numbers will be generated by using Research randomizer software) from the participants who are satisfying the eligible criteria.
3.Intervention : I. Desandun kalka (DK) will be given to the study group in addition to standard treatment and the control group will be given only the standard treatment.Test group will receive 1250 mg of DK, three times a day for 10 days, in addition to the treatment guidelines.
II. The ingredients of DK poly herbal medicine are; Dolichos biflous Linn. - Kollu Glycyrrhiza glabra Linn. – Welmee Acorus calamus Linn. ` - Wadakaha Ptrocarpus santalinus Linn. - Rathandun Santalum album Linn. - Suduhandun Rock salt - Savindalunu
III. Both intervention and control groups will receive standard treatment along with the trial drug. Standard therapy will be as guided by the circular issued by Ministry of Health, Sri Lanka, and will be carried out according to the National guide lines issued by Ministry of Health for Treating Covid 19 patients.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
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1.
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 ] |
|
2.
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 ] |
|
3.
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 ] |
|
4.
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 ] |
|
5.
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 ] |
Secondary outcome(s)
|
1.
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 ] |
|
2.
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 ] |
|
3.
Proportion of patients with 50% reduction in lymphocytopenia by assessing the full blood count |
[ Day 7 and day 10 from the time treatment begins ] |
|
4.
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 ] |
|
5.
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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Target number/sample size
152 (76 in a group)
Countries of recruitment
Sri Lanka
Anticipated start date
2021-03-10
Anticipated end date
2021-09-15
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Department of Ayurveda
Regulatory approvals
N/A
Status
Approved
Date of Approval
2021-02-03
Approval number
COVID 15/20
Details of Ethics Review Committee
| Name: | Ethics Review Committee , FMS/USJP ERC |
| Institutional Address: | Ethics Review Committee, Faculty of Medical Sciences, University of Sri Jayewardenepura Gangodawila, Nugegoda, Sri Lanka |
| Telephone: | 94-11-2758588, |
| Email: | erc.fms.usjp@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. Rameeladevi Thatparan
Medical Officer
"Bandaranaike Memorial Ayurveda Research Institute"
Old Kottawa road .Nawinna, Maharagama.
0112850333
0777317696
rameela10@gmail.com
Contact Person for Public Queries
Dr. Ananda Wijewickrama
Consultant Physician
National Institute of Infectious Diseases.
New Gothatuwa, Angoda, Sri Lanka
0112411284
0777559398
0112410031
anandawijewickrama@hotmail.com
Primary study sponsor/organization
Department of Ayurveda
Old Kottawa road ,Nawinna, Maharagama
0112896912
0112896912
departmentofayurveda@gmail.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
Yes
IPD sharing plan description
All individual Participant data collected during the trial will be shared after de-identification. Study protocol, and statistical analysis will be available immediately after the publication and up to 5 years. Data will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified and authorised for this purpose, to utilize for further research purpose in an approved proposal. The data may be requested by sending the proposals to the e mail as - rameela10@gmail.com,to obtain the data.
Study protocol available
Yes
Protocol version and date
version14, - 04.01.2021
Protocol URL
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
