An Open labeled study in efficacy of add-on Ayurveda intervention in comparison with standard in Covid-19 patients with moderate severity and with type 2 diabetes followed by 60 day follwo-up
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/12/029985
- Lead Sponsor
- AVP Research Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
(i) Confirmed case of COVID with RT-PCR method not requiring ventilator or Intensive Care Unit support at the time of induction (ii) Aged above 18 years and less than equal to 70 years willing to give informed consent. (iii) Patients with Diabetes Mellitus Type II as co-morbidity (v) Arterial SpO2 in Room air less than or equal to 95 % or more than or equal to 90% at baseline (vi) NLR more than or equal to 3 (vii) IL6 not less than 25 (viii) CT score not less than 25% and not more than 50% of Lung consolidation (CORAD Score equivalent to the same) (ix) Patients on both Remdisivir and steroids
Co-morbidities like acute and advanced stage of chronic obstructive pulmonary disease, malignancy, chronic liver diseases, recent history of cardiovascular events, renal diseases, HIV patients, Pregnant and Lactating women, acute inflammatory complications of diabetes like non-healing ulcers /severe neuropathy, Patient requiring ventilator support as decided by medical team, Type I Diabetes Mellitus, History of CVA or Stroke. Covid-19 induced hyperglycemia, any subject having any affiliation to the participating institutions will be excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Improve the response of the patient through integrative therapy <br/ ><br>2. Changes in inflammatory markers IL6, CRP <br/ ><br>3. Modulation of NLR ratio. <br/ ><br>4. Long term effect of Integrative therapy on lung, cardiac, liver and renal functions and neuropsychological symptoms. <br/ ><br> <br/ ><br>Timepoint: Timeline <br/ ><br>Day 0 <br/ ><br>Day 7 <br/ ><br>Day 11 <br/ ><br>Day 14 <br/ ><br>Day 28 <br/ ><br>Day 60 <br/ ><br>
- Secondary Outcome Measures
Name Time Method 5.Changes in Hematological and Biochemical parameter like CBC, Liver function test, Renal function test, Prothrombin time, Ferritin, D-Dimer, TroponinTimepoint: Timeline <br/ ><br>Day 0 <br/ ><br>Day 7 <br/ ><br>Day 11 <br/ ><br>Day 14 <br/ ><br>Day 28 <br/ ><br>Day 60