A clinical trial to study the efficacy and safety of Ayurveda therapy protocol in the management of Covid-19 and its Post complications

A prospective, interventional, single-arm clinical trial to evaluate the efficacy and safety of Ayurveda therapy protocol in the management of mild to moderate COVID-19 patients and its post complications

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/07/034937

Enrollment

Registered

2021-07-16

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

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients tested positive for Covid-19 using RTPCR. 2. Willing and able to provide written informed consent prior to performing study procedures by the subject or legal guardian.

Exclusion criteria

Exclusion criteria: 1. Subject or Authorized Representative is unable to provide informed consent. 2. Subject is pregnant or breastfeeding ladies. 3. Subject is of childbearing potential and has a positive pregnancy test since admission to the hospital. 4. Intra-thoracic or intra-abdominal surgery within the 12 hours prior to consent, or ongoing impairment of hemostasis as a result of one of these procedures. 5. A history of head trauma, spinal trauma, or other acute trauma with an increased risk of bleeding. 6. Cerebral Vascular Accident (CVA) or Intracerebral Arteriovenous Malformation (AVM), cerebral aneurysm, or mass lesions of the central nervous system or melena, hematemesis. 7. Inability to take oral medication 8. Prolonged QTc-interval in baseline ECG ( >500 ms) 9. History of solid organ, allogeneic bone marrow, or stem cell transplantation. 10. Severe renal failure characterized by chronic or acute need of hemodialysis, hemofiltration or peritoneal dialysis. 11. Need of anticoagulants, antiplatelet agents, anti-thrombotics and thrombolytics during the treatment period. 12. Participation in another research study involving an investigational agent within 30 days prior to consent.

Design outcomes

Primary

Measure	Time frame
1. To evaluate the efficacy of Ayurveda treatment protocol in management of Covid-19 and PostCovid complication. 2. To determine the safety of the Ayurveda treatment protocol. 3. To assess the time taken for RTPCR to become negative and normalization of all clinical signTimepoint: During the therapy	—

Secondary

Measure	Time frame
1. To evaluate the effect of the treatment protocol in blood coagulation profile. 2. To evaluate the effect of the treatment protocol in complete blood count and basic inflammatory markers. 3. To evaluate the effect of the treatment protocol in Vitals of the subjects. (BP, HR, PR, RR, SpO2) 4. To check the impact and role of ayurvedic treatment in the changes of radiological/CT imaging scans of major organs like lungs/brain after Covid-19 infection.Timepoint: During the therapy	—

Measure

Time frame

1. To evaluate the effect of the treatment protocol in blood coagulation profile. 2. To evaluate the effect of the treatment protocol in complete blood count and basic inflammatory markers. 3. To evaluate the effect of the treatment protocol in Vitals of the subjects. (BP, HR, PR, RR, SpO2) 4. To check the impact and role of ayurvedic treatment in the changes of radiological/CT imaging scans of major organs like lungs/brain after Covid-19 infection.Timepoint: During the therapy

—

Countries

India

Contacts

Public ContactDrJHareendran Nair

Pankajakasthuri Herbal research Foundation

drshan@pkhil.com9188325339

Outcome results