Evaluation of Immuno-Modulatory Potential of Selected Ayurvedic Formulations in Diabetic People

Not Applicable

Completed

Conditions: Health Condition 1: E119- Type 2 diabetes mellitus without complications

Registration Number: CTRI/2021/07/034740

Lead Sponsor: AYUSH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

i.Age Ã¢â?°Â¥18 or Ã¢â?°Â¤ 75 years at time of signing Informed Consent Form.

ii.Subjects quarantined in the COVID Care centers and frontline healthcare workers.

iii.Cases that have been assigned as mild or very mild cases of COVID suspect.

iv.Cases presenting with fever and/or upper respiratory tract illness (Influenza like illness, ILI).

v.Suspected cases, whose test reports are awaited.

vi.No difficulty in swallowing oral medications.

vii.Must agree not to enroll in another study of an investigational agent prior to completion of study.

Exclusion Criteria

i.Allergies, known to be allergic to research drugs or drug excipients;

ii.Subject weight is less than 40 kg

iii.Cases, who test +ve for COVID-19

iv.Pneumonia with/without signs of severe disease.

v.Patients being referred/admitted to Dedicated COVID Health Centers or Dedicated COVOID Hospitals.

vi.Cases with ARDS or Septic shock.

vii.Patients who have participated in other clinical trials within 1 month.

viii.Known patients with impaired renal function (estimated creatinine clearance <60 mL / min.

ix.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 > 3 times ULN and total bilirubin levels > 2 times ULN.

x.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.