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A study to assess the effectiveness of Ayurvedic formulation in addition to standard of care in COVID-19 positive patients in a tertiary hospital.

Effect of an Ayurvedic Formulation as add-on to standard of care in COVID-19 positive patients in a tertiary hospital

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/04/024882
Enrollment
60
Registered
2020-04-27
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Interventions

Intervention1: Kashaya(Decoction): 90-100 ml of kashaya of Tinospora cordifolia stem added with 2gms of finelly powdered dried Piperlongum fruit,once in the morning before breakfast and once in the ev

Sponsors

Ministry of AYUSH Government of India
Lead Sponsor
Medanta Institute of Education and Research
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Age > 18 years Written Informed consent is documented COVID-19 positive clinical symptoms and (subsequently) confirmed by the current recommended confirmatory test. Can take oral medicines Mild-moderate grade of the disease Subject may be discontinued from the study if confirmatory test results are available subsequently and are negative for COVID 19 infection.

Exclusion criteria

Exclusion criteria: Known sensitivity to any of the ingredients Bleeding haemorrhoids Serious stages of the illnesses ICU admitted patients Pre-existing GI symptoms like nausea or vomiting

Design outcomes

Primary

MeasureTime frame
Percentage of patients progressing to serious/critical stage of disease Progress of disease as per clinical severity score (COCSS) No. of days of treatment, hospitalisation, type of care and site of treatment at hospital, oxygen support requirement, days of ventilation required, period of convalescence and return to normal life activity No. of days taken to test negative for COVID, total days to discharge frm hospital Profiling acc to tridosha Defining the disease according to AyurvedaTimepoint: Observed and recorded on all days of the treatment as relevant Recorded on the days when the investigation is done Recorded on the days when the medication is changed in type or dose Recorded as average of pO2 in a day Recorded as volume of O2 supplied etc

Secondary

MeasureTime frame
No. of days to first clinical symptoms, and what it is No. of days to and of GI symptoms and what they are No. of days of fever and quality of fever (intermittent/remittent, severity, management) No. of days to Cytokine storm, Severity. No. of days it takes to need for ICU mngmnt No. of days of oxygen support/Frequency of need, Scale of hypoxia, Need for High flow oxygen, Number of days to and of Orogastric feeding Other complications The impact on laboratory parametersTimepoint: Observed and recorded on all days of the treatment as relevant Recorded on the days when the investigation is done Recorded on the days when the medication is changed in type or dose Recorded as average of pO2 in a day Recorded as volume of O2 supplied etc

Countries

India

Contacts

Public ContactMr.Kuldeep K Chauhan
drsushilakataria@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026