CTRI Number |
CTRI/2020/07/026371 [Registered on: 05/07/2020] Trial Registered Prospectively |
Last Modified On: |
25/11/2020 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda |
Study Design |
Other |
Public Title of Study
|
Kabasura Kudineer, Shakti drops and Turmeric plus in the management of COVID-19 |
Scientific Title of Study
|
A clinical study to evaluate the effect of AYUSH medicines in the management of COVID-19 |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Ranganatha R |
Designation |
Consultant and HeadPulmonology, Mazumder Shaw Medical Centre |
Affiliation |
Narayana Hrudayalaya, Bangalore |
Address |
Department of Pulmonology
Room No 31
Mazumdar Shaw Medical Centre
Unit of Narayana Hrudayalaya, Bangalore
Bangalore KARNATAKA 560099 India |
Phone |
9740200774 |
Fax |
|
Email |
rrpulmo@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Ranganatha R |
Designation |
Consultant and HeadPulmonology, Mazumder Shaw Medical Centre |
Affiliation |
Mazumder Shaw Medical Centre Narayana Hrudayalaya, Bangalore |
Address |
Department of Pulmonology
Room No 31
Mazumdar Shaw Medical Centre
Narayana Hrudayalaya, Bangalore
Bangalore KARNATAKA 560099 India |
Phone |
|
Fax |
|
Email |
rrpulmo@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr M Ravi Kumar Reddy |
Designation |
Chief Scientific Officer |
Affiliation |
Sri Sri Tattva |
Address |
Research and Development Block , Room No 1
Sriveda Sattva Pvt Ltd 54/56 39th A Cross 11th Main Road 4th
T Block Jayanagar Bangalore Karnataka India 560041
Bangalore
KARNATAKA
Bangalore KARNATAKA 560041 India |
Phone |
09346857001 |
Fax |
|
Email |
dr.ravireddy@srisritattva.com |
|
Source of Monetary or Material Support
|
Sriveda Sattva Private Limited -Sri Sri Tattva
54/56 39th A Cross 11th Main Road 4th
T Block Jayanagar Bangalore Karnataka India 560041 |
|
Primary Sponsor
|
Name |
Sriveda Sattva Private Limited Sri Sri Tattva |
Address |
Sriveda Sattva PvtLtd 54/56 39th A Cross11th Main Road 4th T Block Jayanagar Bangalore Karnataka India 560041 |
Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Ranganath R |
Mazumder Shaw Medical Centre Narayana Hrudayalaya, Bangalore |
258/A, Bommasandra Industrial Area, Hosur Road , Anekal Taluk , Bangalore, Karnataka - 560099 Bangalore KARNATAKA |
9740200774
rrpulmo@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Narayana Health Medical Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
1.Kabasura kudineer
2.Shakti Drops
3.Turmeric plus tablets |
1.Kabasura kudineer 2 tablets taken thrice a day before food
2.Shakti Drops – 6 drops with 100 ml of water thrice a day before food
3.Turmeric plus tablets – 2 tablets thrice a day after food |
Comparator Agent |
only ongoing allopathic medicines |
only ongoing allopathic medicines |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
55.00 Year(s) |
Gender |
Both |
Details |
1. 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 |
|
ExclusionCriteria |
Details |
1. 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.
3. Patients on immuno-suppression therapy
4. Pregnant Women or lactating mothers |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
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
|
Outcome |
TimePoints |
Improvement of quality life of cases of stage 1 and stage 2 of COVID-19 |
1 and 28 th day |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" |
Phase of Trial
|
Phase 3/ Phase 4 |
Date of First Enrollment (India)
|
13/07/2020 |
Date of Study Completion (India) |
Date Missing |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
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. “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.” 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
|