To study the Effectiveness of herbal formulation - Aayudh Advance as a supplementary treatment for the Corona Virus 2019 (Covid-19) infected patients

Phase 2

Completed

• Conditions: Coronavirus as the cause of diseases classified elsewhere,

• Registration Number: CTRI/2020/05/025161
• Lead Sponsor: Ms Shukla Ashar Impex Pvt Ltd

Brief Summary

The study product, Aayudh Advance is a herbal liquid formulation containing mixtures of extracts and essential oils in water medium with sweetener. All the ingredients of formulation are mentioned in the scriptures of the Ayurveda.

In the present study, total 74 mild symptomatic COVID 19 patients were enrolled in the study. Out of which 60 patients completed trial as per the protocol while 14 were withdrawn from the study due to early discharge from the hospital.

The Aayudh Advance was found to be 100% safe without any side effects. Further, there was no occurrences of drug to drug interaction when given concomitantly with Standard Care of Treatment in mild symptomatic covid-19 patients.

The reduction in viral load (inferred by increase in CT value of E gene and RDRP gene) in case of Aayudh Advance treatment was found statistically significant (p<0.01) as compared to Standard of Care alone.

Further % recovery was 15.38 % more in case of Aayudh advance treatment group as compared to Standard of Care alone.

So we can conclude that, test product “Aayudh Advanceâ€, when given concomitantly with standard of care, was 100% safe, more effective as virucidal to reduce viral load, devoid of any drug-drug interaction and increase recovery rate as compared to standard of care alone when tested in mild symptomatic COVID-19 patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-16
• Study Completion: 2020-06-15
• Last Update Posted: 2020-10-27

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 1)Subject willing to sign informed consent.
• 2)Subject age group of 18 years and above of both gender.
• 3)All patients with COVID-19 RT-PCR positive (within 7 days)/ any Covid-19 test kit, admitted to the hospital / healthcare center will be eligible.
• 4)Patients who are having mild to moderate symptoms of Covid-19 disease and tested positive for Covid-19 test.

Exclusion Criteria

• 1)Patient younger than18 years age.
• 2)Women who are pregnant or who intend to become pregnant for the next three months after taking the drug.
• 3)Patients allergic to type medications or any of the ingredient of the formulation.
• 4)Patients with a neurological history (seizures, epilepsy, etc.).
• 5)Patients with a previous history of psychiatric illnesses (depression, anxiety, suicide attempt).
• 6)Patients with severe cardiac pathologies or relevant chronic diseases that in the judgment of the clinician recommend the non-inclusion of the patient in the study.
• 7)Patients who are on artificial ventilation or oxygen supply.
• 9)Patients with severe hypertension, diabetes and other chronic diseases shall be excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1)Rate of Recovery	Every 3-4 days from patient enrollment till recovery of patient and discharged from hospital
2)Symptom Resolution: Fever	Every 3-4 days from patient enrollment till recovery of patient and discharged from hospital
3)Symptom Resolution: Cough	Every 3-4 days from patient enrollment till recovery of patient and discharged from hospital
4)Symptom Resolution: Shortness of breath	Every 3-4 days from patient enrollment till recovery of patient and discharged from hospital

Secondary Outcome Measures

Name	Time	Method
1)Questioning about any number of supplemental side effects observed.	2)Details of any adjunctive medication required during treatment due to supplemental treatment with herbal formulation - Aayudh Advance.

Trial Locations

Locations (1)

Smt. NHL Municipal Medical College & SVPIMSR; 🇮🇳 Ahmadabad, GUJARAT, India

Smt. NHL Municipal Medical College & SVPIMSR

🇮🇳Ahmadabad, GUJARAT, India

Dr Jayesh Dutt

Principal investigator

949426008607

drjayeshjdutt@gmail.com