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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

An Open-labeled study to investigate efficacy of add-on personalized Ayurveda intervention in Covid-19 Patients with moderate diseases severity with type 2 diabetes followed by 60 day follow-up of post-viral syndrome post Covid-19 in comparison to standalone treatment based on ICMR guidelines - AAIC

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/12/029985
Enrollment
100
Registered
2020-12-23
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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: Add-on personalised Ayurveda intervention to ICMR Guideline on Covid-19: Internal Medication: Panchathikthakam Kashayam - (Ref: Bhaishajya Ratnavali Jwara adhikara 113 sloka). Ashtanga

Sponsors

AVP Research Foundation
Lead Sponsor
PSG Institute of Medical Sciences Research
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: (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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
1. Improve the response of the patient through integrative therapy 2. Changes in inflammatory markers IL6, CRP 3. Modulation of NLR ratio. 4. Long term effect of Integrative therapy on lung, cardiac, liver and renal functions and neuropsychological symptoms. Timepoint: Timeline Day 0 Day 7 Day 11 Day 14 Day 28 Day 60

Secondary

MeasureTime frame
5. Changes in Hematological and Biochemical parameter like CBC, Liver function test, Renal function test, Prothrombin time, Ferritin, D-Dimer, TroponinTimepoint: Timeline Day 0 Day 7 Day 11 Day 14 Day 28 Day 60

Countries

India

Contacts

Public ContactSujith Eranezhath

AVP Research Foundation

cso@avpresearch.org

Outcome results

None listed

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