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Clinical trial of Ayurvedic Medicines in Patients with Asymptomatic and/or Mild Symptoms of COVID-19

Evaluation of Immuno-Modulatory Potential of Ayurvedic Medicines in Patients with Mild Symptoms of COVID-19: Single Blinded, Randomized and Controlled Study - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/10/028537
Enrollment
90
Registered
2020-10-22
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: Chyawanprash (Sugar Free) Along with Standard medicine as per ICMR protocol for 21 days and post treatment follow up till 28th day: Dose: 12-24 gm (1-2 teaspoons) morning and evening, A

Sponsors

Shree Baidyanath Ayurved Bhawan Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age more than 18 or less than 75 years at time of signing Informed Consent Form. COVID positive by RTPCR Cases that have been assigned as mild or very mild or asymptomatic cases of COVID. Cases presenting with fever and/or upper respiratory tract illness (Influenza like illness, ILI). No difficulty in swallowing oral medications. Must agree not to enroll in another study of an investigational agent prior to completion of study.

Exclusion criteria

Exclusion criteria: Allergies, known to be allergic to research drugs or drug excipients; Subject weight is less than 40 kg Pneumonia with/without signs of severe disease. COVID Cases with ARDS or Septic shock. Patients who have participated in other clinical trials within 1 month. Known patients with impaired renal function (estimated creatinine clearance During the screening or within 24 hours before screening, patients were found to have any of the following laboratory parameter abnormalities (based on local laboratory reference range):-ALT or AST level 5 times the upper limit of normal range (ULN) or-ALT or AST more than 3 times ULN and total bilirubin levels more than 2 times ULN. Being pregnant or breastfeeding, or having a positive pregnancy test at the time of pre-dose inspection, or planning to become pregnant within 3 months of study treatment.

Design outcomes

Primary

MeasureTime frame
Serum levels of Immunological panel CD4, CD8, NK cell panel CD16/CD56 Serum CRP levels Inflammatory mediators like IL-6 and TNF alpha Change in clinical symptom presentation in Fever, Cough, breathlessness, fatigue and myalgia, loss of taste and smell on 5 point ordinal Timepoint: From Baseline to End of the Study

Secondary

MeasureTime frame
Changes in random blood sugar Hematological parameters like WBS, RBC and platelet count etc. Requirement of admission to Dedicated COVID Hospital Duration of hospital admission Requirement of ICU admission Timepoint: from Baseline to End of the Study

Countries

India

Contacts

Public ContactDr Anurag Gupta

Shree Baidyanath Ayurved Bhawan Pvt. Ltd.

vaidya@baidyanath.co.in9971009222

Outcome results

None listed

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