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

Phase 4

Recruiting

• Conditions: Coronavirus as the cause of diseases classified elsewhere. Ayurveda Condition: A type of Jwara (Kapha-Vata-Samasargaj-Jawara i.e. Sannipataj-Jawara)),

• Registration Number: CTRI/2021/07/034937
• Lead Sponsor: Pankajakasthuri herbal research foundation

Brief Summary

TheCOVID 19 is now spreading throughout the world because of its high infectivityand communicability. Also, there is a lack in the proper management of thedisease. So, any contribution in the knowledge of treatment of COVID 19 fromany source could be of great value to the medical profession. Thus, the presentstudy is proposed to understand the safety and efficacy of Ayurveda therapyprotocol in managing the patients infected with SARS COV2/COVID 19 infection.The treatment protocol comprises a blend of poly herbo mineral formulations,which is formulated with the help of antiviral phytomolecules and processed andpurified natural metallic compounds as per Ayurveda principles. The drug usedin the treatment protocol comprises systematic herbal formulations withappropriate combinations, which are reported to have remarkable antiviral,antipyretic, immunomodulatory effects in treating patients. In the presentprospective, interventional, single-arm clinical trial to evaluate the efficacyand safety of Ayurveda therapy protocol as a standalone antiviral therapymanaging mild to moderate COVID-19 patients and its post complications. This Ayurvedatherapy protocol consist of a combination of three drugs and an eye drops i.e. PulmoCardcaps, Acalogen caps, Opthoxy eye drops and ZingiVir-H tablets. Adult subjectswho meet all inclusion criteria with COVID 19 positive assessment and mildCOVID 19 infection-related symptoms shall be screened into the study. In thepresent prospective, interventional, single-arm clinical trial to evaluate theefficacy and safety of Ayurveda therapy protocol in the management of mild tomoderate COVID-19 patients and its post complications. During this study, wewill know the efficacy and safety of Ayurveda therapy protocol in themanagement of COVID-19 and its Post complications. Further, we can assess thetime taken for RTPCR to become negative and normalize all clinical signs. Inaddition to this, we will also measure the following during the study period.1. To evaluate the effect of the treatment protocol in the blood coagulationprofile. 2. To evaluate the effect of the treatment protocol in complete bloodcount and basic inflammatory markers. 3. To evaluate the effect of thetreatment protocol on the Vitals of the subjects. (BP, HR, PR, RR, SpO2).Safety assessments will be done by assessing any adverse events or SAE in thestudy patients during the treatment period. Paper CRF shall be used in thestudy for data collection. Statistical analysis shall be done, and the studyresults shall be published. A clinical study report shall be prepared and willbe submitted to relevant regulatory authorities.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-02-08
• Study Start: 2021-07-23

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

• Subject or Authorized Representative is unable to provide informed consent.
• Subject is pregnant or breastfeeding ladies.
• Subject is of childbearing potential and has a positive pregnancy test since admission to the hospital.
• 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.
• A history of head trauma, spinal trauma, or other acute trauma with an increased risk of bleeding.
• Cerebral Vascular Accident (CVA) or Intracerebral Arteriovenous Malformation (AVM), cerebral aneurysm, or mass lesions of the central nervous system or melena, hematemesis.
• Inability to take oral medication 8.
• Prolonged QTc-interval in baseline ECG (>500 ms) 9.
• Severe renal failure characterized by chronic or acute need of hemodialysis, hemofiltration or peritoneal dialysis.
• Need of anticoagulants, antiplatelet agents, anti-thrombotics and thrombolytics during the treatment period.
• Participation in another research study involving an investigational agent within 30 days prior to consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pankajakasthuri Ayurveda Medical college Kattakkada Trivandrum; 🇮🇳 Thiruvananthapuram, KERALA, India

Pankajakasthuri Ayurveda Medical college Kattakkada Trivandrum

🇮🇳Thiruvananthapuram, KERALA, India

DrJHareendran Nair

Principal investigator

9447096201

md@pkhil.com