CTRI

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

COVID -19 is an illness caused due to novel corona virus 2, now called as Severe Acute Respiratory Syndrome Corona Virus -2 (SARS CoV 2). It was first reported from Wuhan City, China. It was declared as a pandemic by WHO on March11,2020, as ith as confirmed its presence in all continents except Antarctica [1].

Ayurveda has unique methods of approaching a newly detected disease. Rather than focusing on the microbiological etiology, Ayurveda embraces a holistic technique for elaborating the details of the disease at hand, with a three pointed approach in the elaboration of an unknown disease-the natural history of the disease (VikaraPrakriti), the site of the pathological process (Adhishtanam/Srotasa) and etiological features (SamuthaanaVisesham)[2]

Study design: Multi centric, open labelled, randomised controlled trial

Site name: Department of Pulmonology, Mazumdar Shaw Medical Centre, Narayana Hrudayalaya, Bangalore

Study duration:

Period required for pre-trial preparation: three months (Including drug preparations) Period which may be needed for collecting the data: one year Period that may be required for analyzing the data: Three months (3 months)

No of groups: 2 groups

Group A-trial group- Ayurveda treatment with ongoing allopathic medicines

Group B- Standard control group–only on going allopathic medicines

“Patients who are included in the standard care will be given an option for taking AYUSH medicines (Kabasura Kudineer tablets, Shakti drops, Turmeric tablets) at the end of 14 days irrespective of the RTPCR status or continue in the standard care. If the participant is interested, the medications will be dispensed for 21 days and will be followed up till end of intervention. If the participant continues in the standard care the trial period and follow up will remain unchanged.”

Inclusion criteria

Age limit – 20 to 55 years, both Male &Female

Uncomplicated cases of COVID19 patients on Allopathic medication of stage 1 and stage 2

Patients whom ventilator support is not required

Patients with no associated comorbidities

Patients willing to give their consent to participate in the clinical trial

Exclusion criteria

COVID-19 positive patients above 55 years of age & below 20 years

Patients with associated comorbidities like hypertension, type 2 or type 1 diabetes or chronic or acute renal failure

Patients on immuno-suppression therapy

Pregnant Women or lactating mothers

Patients in advanced stage of disease requiring emergency medical intervention like pneumonia, bronchial asthma, Pre Existing Cardiac condition, organ failure.

Procedure

The study will be initiated after Institute ethics committee approval and the study will be registered in Clinical Trial registry of India. Clinical study will be carried out in adult cases of stage1 and stage2 of COVID-19 who are undergoing standard allopathic treatment. The patients presenting with signs and symptoms of stage 1 and stage 2 of COVID-19, attending the hospital and fulfilling the criteria of diagnosis and inclusion criteria, willing to give their consent to participate in the clinical trial will be registered. These registered patients will be then randomly divided by computer generated randomization sequence in group A and group B. Each registered patient will be provided the details of clinical trial by patient information sheet and after taking their consent, detailed history will be taken as per clinical research Performa and generated data will be used for research.

Group A: In this, along with ongoing allopathic medicines below mentioned Ayurveda treatment will be given to Patients presenting with stage 1 symptoms of COVID -19 like Sore throat/ congestion in throat, fever, slight cough, nasal congestion, malaise and headache

Kabasura kudineer 2 tablet taken thrice a day before food

Shakti Drops – 6 drops with 100 ml of water thrice a day before food

Patients presenting with stage 2 of COVID-19 like dry cough, breathlessness, pain and discomfort in the chest with fever. In addition to Kabasura Kudineer Tablets and Shakti Drops as mentioned in stage 1,

Turmeric plus tablets – 2 tablets thrice a day after food

Along with this, ongoing allopathic medicines will be allowed. Along with this, patients will be advised dietary and life style modifications. For this, patients will be asked to take freshly prepared easily digestible, light diet and to avoid using sweets and food which is heavy to digest, chilled, fried, oily, fermented food items, cold and refrigerated food /beverages.

Group B- Standard control group – only ongoing allopathic medicines.

Total duration of the therapy: 21 days

Follow up: for 28 days

Primary and secondary endpoint

Early recovery in the signs and symptoms of cases of stage 1 and stage 2 of COVID-19 by adding Ayurvedic medicines which are effective in fever, symptoms of respiratory tract and by enhancing immunity of body by adding Rasayana drugs

Improvement of quality life of cases of stage 1 and stage 2 of COVID-19