Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Sugar Free Chyawanprash: 60 diabetic subjects will be provided 20 gm chyawanprash per day for the study duration i.e. 84 days.
Control Intervention1: Normal Chyawanprash: 60 healthy sub
Sponsors
AYUSH
Eligibility
Inclusion criteria
Inclusion criteria: i. Age >=18 or 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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This study will find the role of Chyawanprash in diabetic subjects.Timepoint: We will evaluate the immunomodulatory effect of Chyawanprash by assessing given biochemical , immunological parameters at day 0, Day 21 and Day 84. | — |
Secondary
| Measure | Time frame |
|---|---|
| This study outcome will make a substantial background for the role of polyherbal formulation as immunity booster for other weak immunity related diseases.Timepoint: baseline at Day 0, assessment at 3 weeks and 12 weeks | — |
Countries
India
Contacts
Public ContactDr Satyendra Kumar Singh
King Georges Medical University
Outcome results
None listed