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CTRI Number  CTRI/2020/06/025998 [Registered on: 20/06/2020] Trial Registered Prospectively
Last Modified On: 18/06/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Efficacy of An Ayurvedic Preparation Raj Nirwan Bati (RNB) on symptomatic COVID-19 Patients 
Scientific Title of Study   To Determine the Efficacy of An Ayurvedic Preparation Raj Nirwan Bati (RNB) on symptomatic COVID-19 Patients: A Double-Blind Randomized Controlled Trial 
Trial Acronym  RNB 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Raj Kumar 
Designation  Vice Chancellor 
Affiliation  Uttar Pradesh University of Medical Sciences 
Address  Uttar Pradesh University of Medical Sciences, Saifai, Etawah

Etawah
UTTAR PRADESH
206130
India 
Phone  9450610933  
Fax  05688276509  
Email  rajkumar1959@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Naresh Pal Singh 
Designation  Professor (Junior Grade) 
Affiliation  Uttar Pradesh University of Medical Sciences 
Address  Department of Community Medicine, Uttar Pradesh University of Medical Sciences, Saifai, Etawah

Etawah
UTTAR PRADESH
206130
India 
Phone  09458641119  
Fax  05688276509  
Email  nareshpalsingh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Raj Kumar 
Designation  Vice Chancellor 
Affiliation  Uttar Pradesh University of Medical Sciences 
Address  Uttar Pradesh University of Medical Sciences, Saifai, Etawah

Etawah
UTTAR PRADESH
206130
India 
Phone  9450610933  
Fax  05688276509  
Email  rajkumar1959@gmail.com  
 
Source of Monetary or Material Support  
Uttar Pradesh University of Medical Sciences, Saifai, Etawah, UP 
 
Primary Sponsor  
Name  Uttar Pradesh University of Medical Sciences 
Address  Saifai, Etawah, UP 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ramakant Rawat  Uttar Pradesh University of Medical Sciences  Isolation Ward, COVID-19 Hospital, Saifai, Etawah
Etawah
UTTAR PRADESH 
6395926272
05688276509
ramakant.gsvm@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, UPUMS, Saifai, Etawah  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  Sugar gelatin capsule with 4 small balls of sugar twice a day empty stomach for 12 days 
Intervention  Raj Nirwan Bati capsule  1. Mercury (Para) 2. Sulphur (Gandhak) 3. Gold (Sona) 4. Silver (Chandi) 5. Clamina Perpeta 6. Arsenic Trioxide (Hartal Bhasma) 7. Black pepper (Kaali Mirch) 8. Naag Damanti (Snake Plant) 9. Celery (Azwaiyan) 10. Zinc 11. Niramish (Mahamash oil) One Raj Nirwan Bati capsule of 125 mg (1 Ratti) twice a day empty stomach for 12 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. RT-PCR confirmed SARS-CoV-2 infected symptomatic patients admitted to the COVID-19 hospital of UPUMS
2. Patients falling in mild, moderate and severe category of COVID-19 illness
3. Patients more than 18 years of age
 
 
ExclusionCriteria 
Details  1. All critically ill patients of COVID-19
2. Patients not providing informed written consent for the study
3. Pregnant and lactating females
4. Patients of Chronic kidney disease (CKD) more than stage three
5. Asymptomatic cases
6. Study participants becoming critically ill during the course of intervention.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Micro-biologically becoming RT-PCR negative for SARS-CoV-2  Micro-biologically RT-PCR results for SARS-CoV-2 shall be evaluated at baseline, day 6 and day 12 
 
Secondary Outcome  
Outcome  TimePoints 
1. Persistence of symptoms beyond day 5 in mild cases and day 7 in moderate cases
2. Worsening of clinical features beyond day 5 except severe cases
3. Changes in bio-chemical parameters like LDH, CRP, SGPT, SGOT
4. Changes in haematological parameters
5. Radiological worsening.
 
These parameters will be evaluated on day 1, day 6 and day 12 after start of intervention. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   30/06/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   1. Raj kumar, Ramakant Yadav, Ramakant Rawat, Prashant Kumar Bajpai, Indra Kumar Sharma, Sushil Kumar, Prashant Yadav. Role of Raj Nirvan Bati in treatment of COVID19 RT-PCR positive cases. IJSRM June 2020; Accepted for publication 2. 1. Raj kumar, Ramakant Yadav, Ramakant Rawat, Prashant Kumar Bajpai, Indra Kumar Sharma, Sushil Kumar, Prashant Yadav. Raj Nirvan Bati (A novel ayurvedic preparation) in RT PCR positive COVID19 cases: An interventional study. IJMSCR June 2020;3(3) 
Brief Summary  

Name of title:

To Determine the Efficacy of An Ayurvedic Preparation, Raj Nirwan Bati (RNB) on Symptomatic COVID-19 Patients: A Double-Blind Randomized Controlled Trial

Aim and Objectives:

1.     To determine the efficacy of an ayurvedic preparation Raj Nirwan Bati (RNB) in treatment of symptomatic COVID-19 Patients.

2.     To find out the duration of conversion of symptomatic patients to asymptomatic

3.     To find out the duration for becoming RT-PCR negative

4.     To evaluate the therapeutic response of RNB on bio-chemical and haematological profile.

 

Material and Methods:

Study design: A double-blind randomized controlled trial

Study units: Symptomatic patients diagnosed to be infected with SARS-CoV-2 and suffering from COVID-19 illness.

Place of study: Patients admitted in the indoor department of COVID-19 hospital at Uttar Pradesh University of Medical Sciences, Saifai, Etawah, Uttar Pradesh.

Study Duration: June 2020 onwards till the outcome variables in the study patients are met.

Sample Size: 30 cases in Intervention group and 30 in Control group

Study intervention tool: An ayurvedic preparation by the name of Raj Nirwan Bati (RNB).

Inclusion criteria:

1.     RT-PCR confirmed SARS-CoV-2 infected symptomatic patients admitted to the COVID-19 hospital of UPUMS

2.     Patients falling in mild, moderate and severe category of COVID-19 illness

3.     Patients more than 18 years of age

Exclusion Criteria:

1.     All critically ill patients of COVID-19

2.     Patients not providing informed written consent for the study

3.     Pregnant and lactating females

4.     Patients of Chronic kidney disease (CKD) more than stage three

5.     Asymptomatic cases

6.     Study participants becoming critically ill during the course of intervention.

 

Methodology:

As an initial step, all suspected or laboratory confirmed patients coming to COVID-19 hospital of UPUMS, Saifai, Etawah shall be screened both clinically and by repeat laboratory tests to confirm the SARS-CoV-2 infection status and make the diagnosis of COVID-19. Those patients providing the consent and fall in mild, moderate and severe category of COVID-19 illness shall comprise our study units or subjects. Patients with fever, dry cough, myalgia and other non-specific symptoms will be categorized as “mild illness” while “moderate illness” will have above symptoms along with dyspnoea on exertion or tachypnoea (Respiratory rate > 18/minute and oxygen saturation > 94%. The “severe illness” category of patients will be having any of the above sign and symptom with oxygen saturation between 90-94%.

After the initial screening, random allocation of these patients will be done in the intervention group and control group. Both groups or arms of the RCT will comprise of a sample of 30 patients in each study group. A battery of bio-chemical, haematological, micro-biological, radiological and other specific tests required for the management of co-morbid disease shall be performed on the selected study patients. The intervention group of patients will receive the Raj Nirwan Bati (RNB) in dose of 125 mg (1 Ratti) tablet twice a day with 5 to 10 ml honey/desi ghee empty stomach for duration of 12 days. On the other hand, the control group of patients will be administered placebo in the form of calcium tablet.

All the patients of both intervention and control group will receive the allopathic treatment as per standard protocols of the university. Regular vitals monitoring will be done of all the patients. Their repeat naso-pharyngeal swab will be taken for SARS-CoV-2 infection by RT-PCR examination on day 6 and 12 of RNB therapy. Routine investigations like complete blood count, Liver function tests, Renal function tests, LDH, CPK, CRP, Chest X-ray PA view, Ultrasonographic examination will be done at the time of admission and will be repeated on day 6 and day 12 of the illness.

The outcome variable of the study will be in the form of status of patients 

1. RT-PCR report negative at day 6 of intervention

2. Persistence of symptoms beyond day 5 in mild cases and day 7 in moderate cases

3. Worsening of clinical features beyond day 5 except severe cases

4. Changes in bio-chemical parameters like LDH, CRP, SGPT, SGOT

5. Changes in haematological parameters

6. Radiological worsening.

Statistical Analysis:

Data thus collected shall be entered in Excel spreadsheet and analysed using spss statistical software (version 21) using appropriate tests.

 
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