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CTRI Number  CTRI/2020/10/028364 [Registered on: 12/10/2020] Trial Registered Prospectively
Last Modified On: 04/05/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda
Nutraceutical 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to evaluate the effectiveness and safety of Vedicinals-9-a Herbal Formulation in Mild to Moderate COVID-19 Patients. 
Scientific Title of Study   Randomized, Open Label, Parallel efficacy, Active Control, Multi-Centre Exploratory Trial to Evaluate Efficacy and Safety of Vedicinals-9, a Herbal Formulation as an Adjunct Treatment to Standard of Care for the management of Mild to Moderate COVID-19 Patients. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
EPRD0202-010920_V1R1_28.09.2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Govinda Narke 
Designation  Principal Investigator 
Affiliation  Sai Baba Health Care 
Address  Department of Community Medicine, Quarantine care, Room 1, Office No. 3, Pushkraj Apartment, S.No. 674, Near Sat-Toti Police Chowki, Behind 8 No. Shala, Beside Namdev Shimpi Karyalay, Kasba Peth, Pune

Pune
MAHARASHTRA
411011
India 
Phone  9011078989  
Fax    
Email  narkegovinda@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Yogendra Kumar Choudhary 
Designation  CEO  
Affiliation  Ethix Pharma 
Address  Department of Research and Development, Clinical Research Division, CCRP-315, Ambuja City Centre, Vidhan Sabha Road, Mowa Raipur

Raipur
CHHATTISGARH
492001
India 
Phone  9039340075  
Fax    
Email  yogendrakumar.choudhary@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Yogendra Kumar Choudhary 
Designation  CEO  
Affiliation  Ethix Pharma 
Address  Department of Research and Development, Clinical Research Division, CCRP-315, Ambuja City Centre, Vidhan Sabha Road, Mowa Raipur

Raipur
CHHATTISGARH
492001
India 
Phone  9039340075  
Fax    
Email  yogendrakumar.choudhary@gmail.com  
 
Source of Monetary or Material Support  
Vedicinals India Pvt. Ltd., J-204, Devi Indrayani Apartments, Dehu-Alandi road, Talawade, Pune -411062, Maharashtra, India 
 
Primary Sponsor  
Name  Vedicinals India Pvt Ltd 
Address  J-204, Devi Indrayani Apartments, Dehu-Alandi road, Talawade, Pune -411062, Maharashtra, India 
Type of Sponsor  Other [Herbal & Nutraceutical Industry Global] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Navneet Singh Gill  Aakash Healthcare Super Speciality Hospital  Department of Clinical Research, Service floor, Hospital Plot, Road No. 201, Sector-3, Dwarka, New Delhi- 110075
New Delhi
DELHI 
9810203522

gillenclave@rediffmail.com 
Dr Rohit Parate  Chirayu Medical College and Hospital  Department of Medicine, Ground Floor, Bhopal Indore Highway, near Bairagarh, Bhopal – 462030, Madhya Pradesh
Bhopal
MADHYA PRADESH 
9630033342

rohitparate963@gmail.com 
Dr Govinda Narke  Sai Baba Health Care  Department of Community medicine, Quarantine care, Room no. 1, Office No. 3, Pushkraj Apartment, Sr. No. 674, Near Sat-Toti Police Chowki, Behind 8 No. Shala, Beside Namdev Shimpi Karyalay, Kasba Peth, Pune-411011, Maharashtra, India
Pune
MAHARASHTRA 
9011078989

narkegovinda@gmail.com 
Dr Nitin Shinde  Samhita Yog and Ayurved Centre  Department of Clinical Research, Room no. 2, 101, City Plaza, Near Karnataka Bank, Pune Solapur Road, Hadapsar Gaon, Hadapsar, Pune-411028, Maharashtra, India
Pune
MAHARASHTRA 
9422503748

shinden1977@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Aakash Healthcare Super Speciality Hospital Institutional Ethics Committee  Approved 
Independent Research Ethics Committee, Pune (IRECP)  Approved 
Independent Research Ethics Committee, Pune (IRECP)  Approved 
Vision Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
Comparator Agent  Standard Care  Standard Care as per the Ministry of Health and family welfare guidelines for COVID-19.  
Intervention  Vedicinals-9 along with standard care  Vedicinals-9-Active (9 compounds) 5000 mg in Additive 50 ml suspension per day [100 mg/ml suspension] Loading dose on day 1 - 25 ml each at 1 hour before breakfast, lunch and dinner. Maintenance dose from day 2 to day 12 ± 2 days - 20 ml, 15 ml and 15 ml at 1 hour before breakfast, lunch and dinner, respectively. Standard Care-as per the Ministry of Health and family welfare guidelines for COVID-19.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Individuals of either sex above 18 and below 60 years of age
2. Individuals who have been tested positive to be infected with SARS-COV2 Virus and presenting with no symptoms or mild to moderate symptoms.
3. Voluntariness to participate in the trial and give signed informed consent.
 
 
ExclusionCriteria 
Details  1. COVID-19 Patients with symptoms classified as severe or critical
2. Individuals with uncontrolled, unstable comorbidities as evaluated by the investigators.
3. Individuals with preexisting respiratory conditions, severe primary respiratory disease or pneumonia.
4. Immuno-compromised Individuals or those on immunosuppressant
5. Patients on or requiring parenteral nutrition/care.
6. Pregnant/lactating women.
7. COVID-19 positive individuals participating in the interventional arm of other COVID-19 clinical trial.
8. Individuals with serious complications of diseases such as cancer, heart disease, infraction, stroke, arterial fibrillation, cardiac arrhythmia, disabilities, neurodegenerative disease.
9. Subjects with alcohol and/or substance dependence.
10. Subjects with known allergic reactions to any other herbal supplements.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
a) Percentage of COVID-19 patients and time taken to get COVID-19 RT-PCR negative
b) Time of convalescence and improvement in altered biomarkers post COVID-19 infection  
a) Days from admission, days from first testing positive, days from first noticed symptoms

b) At screening, day 5, day 12 and day 45 
 
Secondary Outcome  
Outcome  TimePoints 
Time to allaying a fever  Days from admission, days from first testing positive, days from first noticed symptoms 
Arrest or delay in progression of asymptomatic symptoms to mild or moderate to severe to critical.  Days from admission, days from first testing positive, days from first noticed symptoms 
Time to symptom relief  Days from admission, days from first testing positive, days from first noticed symptoms 
Change in the Patient reported score of each of the 7 influenza symptoms – cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue.  Screening, day 1, day 5, day 12 and day 45 
Days of treatment and hospitalization  From day 1 to end of study 
Incidence of respiratory failure and requirement of rescue medication  Throughout the study period 
Percent Mortality  End of the study 
 
Target Sample Size   Total Sample Size="124"
Sample Size from India="124" 
Final Enrollment numbers achieved (Total)= "124"
Final Enrollment numbers achieved (India)="124" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   19/10/2020 
Date of Study Completion (India) 14/04/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="5"
Days="15" 
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)?  

Response - NO
Brief Summary  
The objective of this study is to evaluate the effectiveness and safety of Vedicinals-9 - a herbal formulation as adjunct treatment to standard of care for the management of Mild to Moderate COVID-19 Patients. A total of 124 adults with influenza like symptoms and confirmed COVID-19 patients with mild to moderate symptoms or asymptomatic will be recruited for the trial. The patients will be randomly assigned into the following two groups; Standard care group (n=62) and Herbal Formulation Treatment Group 5000 mg per day in 50ml suspension add on to standard treatment (n=62). These enrolling and allocation procedures will be as per randomization schedule. Patients will consume either standard treatment alone or in combination with herbal formulation for 12±2 consecutive days at a dose of 5000 mg per day TID daily. The patients in Herbal Formulation Treatment Group will receive loading dose on day 1 of 25 ml each at 1 hour before breakfast, lunch and dinner. On subsequent days, the patients will receive the maintenance dose of 20 ml, 15 ml and 15 ml at 1 hour before breakfast, lunch and dinner, respectively. At Day 0, 5 and 12 of ingestion, the post-ingestion test and patient influenza symptom will be conducted along with other hematological, biochemical and biomarkers test. A follow-up protocol of 30 days will be conducted after the end of treatment period and all the hematological, biochemical and biomarker tests will be conducted on day 45.
 
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