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CTRI Number  CTRI/2020/06/026161 [Registered on: 26/06/2020] Trial Registered Prospectively
Last Modified On: 21/02/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study
Modification(s)  		 Drug Trial to Evaluate Efficacy and Safety of an Ayurvedic Formulation II [Sanshamani Vati Plus] as Adjunct Treatment to Standard of Care for the management of Mild to Moderate COVID-19 Patients 
Scientific Title of Study
Modification(s)  		 A Randomized, Open Label, Parallel Efficacy, Active Control, Multi-Centre Exploratory Drug Trial to Evaluate Efficacy and Safety of an Ayurvedic Formulation II [Sanshamani Vati Plus] as 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 
COVID 19/AYUSH-ICMR 2020/Adjunct Protocol-AF-II  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pranjal Ausekar 
Designation  Head-Operations & Project Management 
Affiliation  Ardent Clinical Research Services 
Address  Office: 318, Next to Frankfin, Level-3, Connaught Place,
Bund Garden Road, Pune-411001, MH, India.
Pune
MAHARASHTRA
411001
India 
Phone  7276283528  
Fax  -  
Email  pranjal@ardent-cro.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dilip Mondhe 
Designation  Senior Principal Scientist & Head Cancer Pharmacology Division & IIIM-Dispensary 
Affiliation  Indian Institute of Integrative Medicine (Council of Scientific & Industrial Research) 
Address  Clinical Research Department, Canal Road,
Jammu 180001 (J & K)
Jammu
JAMMU & KASHMIR
180001
India 
Phone    
Fax  -  
Email  dmmondhe@iiim.ac.in  
 
Details of Contact Person
Public Query  
Name  Mr Chandu Devanpally 
Designation  Founder & Managing Director 
Affiliation  Ardent Clinical Research Services 
Address  Office: 318, Next to Frankfin, Level-3, Connaught Place,
Bund Garden Road, Pune-411001, MH, India.
Pune
MAHARASHTRA
411001
India 
Phone  9545817447  
Fax    
Email  cdevanpally@ardent-cro.com  
 
Source of Monetary or Material Support  
AYUSH-CSIR,Canal Road, Jammu 180001 (J & K)  
 
Primary Sponsor  
Name  AYUSHCSIR 
Address  Canal Road, Jammu 180001 (J & K) 
Type of Sponsor  Government funding agency 
 
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 S K Sonkar  King Georges Medical University& Hospital  Department of Medicine, Shamina Road, Chowk, Lucknow-226003
Lucknow
UTTAR PRADESH 		 9307288648
-
satyendra.sonkar@gmail.com 
Dr Sushila Kataria  Medanta Institute of Education and Research  Department of Internal medicine, Senior Director
Gurgaon
HARYANA 		 124-4855100
-
sushils.kataria@medanta.org 
Dr Atul Rajkondawar  Meditrina Institute of Medical Sciences  Department of Medicine, 278, Central Bazar Road, Ramdaspeth, Nagpur
Nagpur
MAHARASHTRA 		 9373215775
-
atul.rajkondawar@gmail.com 
Dr Danish Menon  Noble Hospital Institutional Ethics Committee  Auditorium Room, 6th Floor, 153, Magarpatta City Road, Hadapsar, Pune
Pune
MAHARASHTRA 		 08888226601
-
danish1331@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Medanta Institutional Ethics Committee  Approved 
Meditrina Intitute Ethics Commitee  Approved 
Noble Hospital Constitutional 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 
Intervention  Formulation 2 And SOC  Guduchi+Pippali [T. Cordifolia + Piper longum] Administered along with standard of care 2 tablets bid (twice daily) with warm water for 12 weeks. 
Comparator Agent  Standard of Care  As per Hospital SOP 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  i) Typical clinical presentation of acute onset febrile illness with cough and a RT_PCR based laboratory confirmation test for COVID-19. The patients may have other symptoms such as fever (patients with episodes of fever up to 48 hrs. and constant fever reading will be considered), myalgia, headache, diarrhoea and tastelessness suggestive of COVID-19.
ii. Patients with mild to –moderate diseasePatients must agree not to share medication
iii. Patients willing to participate and sign an informed consent 
 
ExclusionCriteria 
Details  i. Patients suffering from severe COVID-19 Disease as judged by a physician
ii. Chronic, Severe, Unstable, Uncontrolled co-existent medical illness such as Diabetes, Hypertension, Cardiac disorders, liver, kidney disorders and lung disorders or other disease of concern which may put the patient at increased risk during the study
iii. History of immunosuppression: solid organ or bone marrow transplant, use of immunosuppressive antimetabolic and biologic agents, intrinsic immunodeficiencies, HIV infection.
iv. Active cancer diagnosis, on palliative treatment or requiring current therapy with antimetabolic agents, immunotherapy or radiotherapy.
v. Atleast one fever episode every 24 hours for > 72h
vi. Patients on parenteral nutrition
vii. Patients with known sensitivity or contraindication to any of the ingredients of study medication
viii. History of bleeding haemorrhoids, haemoptysis, acid peptic diseases, ulcers and pulmonary diseases (tuberculosis, asthma, etc.)
ix. Patients who are likely to worsen or planned ICU admission or ventilator support due to any reason
x. Pregnancy and lactation
xi. Participation in a drug interventional clinical drug trial of any nature in the three month period preceding onset of COVID-19
xii. Participation in any other clinical trial of an experimental agent treatment for COVID-19
xiii. Patients on any kind of Ayurveda treatment or any other alternative and complementary medicinal systems such as Homeopathy, Unani, Siddha and in particular requiring oral therapy of any kind.
xiv. Physician decision that involvement in the study is not in the patient´s best interest 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
a) Mean time (days) for clinical recovery [Day of randomization to the day of clinical recovery (see criteria below)]
b) Proportion of patients showing clinical recovery 		 Time Frame: From baseline up to 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1) Rate of patients with negative SARS-CoV-2 on nasal or throat swab in a 2 day continuous real time RT-PCR test
2) Timelines (days counted from onset of illness)- normal body temperature, absence or minimal cough (see ‗clinical recovery‘ for the definition), absence of dyspnoea, onset of clinical pneumonia, pneumonia  		 From Baseline up to 12 weeks 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)
Modification(s)  		 21/09/2020 
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="0"
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)  
Coronavirus Disease-19 (COVID-19) pandemic has unleashed an unprecedented damage to life and livelihood. Over four Million people have contracted the disease globally and almost 2.7 lakh have died by the end of April 2020. There is no specific therapy and the vaccine is likely to be ready by early 2021 if not earlier. All the global strategies are focussed on stringent measures to contain the virus and mitigate the suffering of the people. India is under lockdown since early March 2020 and the situation though grim is fairly stable. There is an upward trend in number of cases but the health care system is suitably meeting the challenge. Clinical research is a vital part of such epidemics. There is a dire need to find newer more effective drugs or at least improve the current standard of care.
India has a rich tradition of Ayurveda since ancient times and several ‗Rasayana ‘drugs are well known to enhance the immunity status. Though COVID 19 is an acute infectious disease with a predominant affliction for lungs and airways, the clinical experience so far has shown a rapidly progressive inflammation triggered by several exuberant immunological events. Therefore, there may be a potent role of immunity enhancing and or Immuno modulators drugs in the medical management of COVID 19. It is against this perspective that the Ministry of AYUSH and Council of Scientific & Industrial Research (CSIR) have initiated an ambitious and comprehensive research program to discover Ayurveda formulations with proven value in the chemoprophylaxis and treatment of COVID 19.
This is a prospective, randomized, open label, blinded end point (PROBE), parallel efficacy, multicentric, two arm study to compare the efficacy of a combination of Standard of Care SOC) plus one of the selected individual Ayurveda herbal drug Samshamani Vati Plus ) to SOC (active control). The Ayurveda drug is being considered as an adjunctive or an add-on therapy and  drug will be evaluated in  two arm trial study design. The drug trials is ‗ ‘exploratory’ in design. The Study Flow diagram summarizes the study design and schedule of events.


 
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