Kabasura Kudineer, Shakti drops and Turmeric plus in the management of COVID-19
- Conditions
- Coronavirus as the cause of diseases classified elsewhere,
- Registration Number
- CTRI/2020/07/026371
- Lead Sponsor
- Sriveda Sattva Private Limited Sri Sri Tattva
- Brief Summary
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.â€
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.
“Patients who are included in the standard care willbe given an option for taking AYUSH medicines(Kabasura Kudineer tablets, Shakti drops,Turmeric tablets) at the end of 14 days irrespectiveof the RTPCR status or continue in the standardcare. If the participant is interested, the medicationswill be dispensed for 21 days and will be followedup till end of intervention. If the participantcontinues in the standard care the trial period andfollow up will remain unchanged.â€
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
- Age limit – 20 to 55 years, both Male &Female 2.
- Uncomplicated cases of COVID19 patients on Allopathic medication of stage 1 and stage 2 3.
- Patients whom ventilator support is not required 4.
- Patients with no associated comorbidities 5.patientswillingtogivetheirconsenttoparticipateintheclinicaltrial.
- COVID-19 positive patients above 55 years of age & below 20years 2.
- Patients with associated comorbidities like hypertension, type 2 or type 1 diabetes or chronic or acute renal failure or pre -existing cardiac conditions.
- Patients on immuno-suppression therapy 4.
- Pregnant Women or lactating mothers.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 1,14,21 and 28 the day
- Secondary Outcome Measures
Name Time Method Improvement of quality life of cases of stage 1 and stage 2 of COVID-19 1 and 28 th day
Trial Locations
- Locations (1)
Mazumder Shaw Medical Centre Narayana Hrudayalaya, Bangalore
🇮🇳Bangalore, KARNATAKA, India
Mazumder Shaw Medical Centre Narayana Hrudayalaya, Bangalore🇮🇳Bangalore, KARNATAKA, IndiaDr Ranganath RPrincipal investigator9740200774rrpulmo@gmail.com