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CTRI Number  CTRI/2021/03/032446 [Registered on: 31/03/2021] Trial Registered Prospectively
Last Modified On: 07/07/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparator study with Standard of care treatment and Investigational product (HAVR-122008) in Uncomplicated Respiratory Viral Infection. 
Scientific Title of Study
Modification(s)  		 An Open-label, Randomized, Three Arm, comparative, standard control Clinical Study to evaluate the safety and efficacy of HAVR-122008 in the Treatment of uncomplicated respiratory viral infection. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrSDinesh 
Designation  Consultant Pulmonologist 
Affiliation  Bangalore Orthopaedic And Surgical Hospital (BOSH) 
Address  Department of Respiratory Medicine, Room no.1, 426, 4th Cross Rd, HRBR Layout 2nd Block, HRBR Layout, Kalyan Nagar

Bangalore
KARNATAKA
560043
India 
Phone  9886125229  
Fax    
Email  bhaktha.dinesh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrSrikrishna 
Designation  Research Scientist  
Affiliation  The Himalaya Drug Company 
Address  The Himalaya Drug Company, Room No 301,3rd Floor Medical Services & Clinical Development,Reserach and Development Makali,Tumkur Road,

Bangalore Rural
KARNATAKA
562162
India 
Phone    
Fax    
Email  dr.srikrishna@himalayawellness.com  
 
Details of Contact Person
Public Query  
Name  DrSoorya Narayan 
Designation  Clinical Trial Manager 
Affiliation  The Himalaya Drug Company 
Address  The Himalaya Drug Company, Room No 301,3rd Floor Medical Services & Clinical Development, Reserach and Development Makali,Tumkur Road,

Bangalore Rural
KARNATAKA
562162
India 
Phone    
Fax    
Email  dr.sooryanarayan.h@himalayawellness.com  
 
Source of Monetary or Material Support  
The Himalaya Drug Company, Makali, Bengaluru 562 162, India  
 
Primary Sponsor  
Name  The Himalaya Drug Company 
Address  Makali, Makali Aluru Main Rd, Opp JCB, Bengaluru, Karnataka 562162  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrAbdul Matheen  Medlife Clinic  Department of Medicine, Room no. 2, No.81, 5th Main Road, Minhajnagar, Kadrenahalli, Banashankari Stage 2, J. P Nagar Post
Bangalore
KARNATAKA 		 9449767229

mateenathar@yahoo.co.in 
DrSDinesh  Bangalore Orthopaedic And Surgical Hospital (BOSH)  Department of Respiratory Medicine, Room no.1, No.426, 4th Cross Rd, HRBR Layout 2nd Block, HRBR Layout, Kalyan Nagar,
Bangalore
KARNATAKA 		 9886125229

bhaktha.dinesh@gmail.com 
DrAsiya BiBi  Swabhimaan Clinic  #12, K.No.149/9, ground floor, B Block, subhashnagar, Bangalore-560068
Bangalore
KARNATAKA 		 8310808709

asiyamuhammadi4@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
ACE Independent Ethic Committee  Approved 
ACE Independent Ethics Committee  Approved 
ACE Independent Ethics Committee  Approved 
ACE Independent Ethics Committee  Approved 
ACE Independent Ethics Committee  Approved 
ACE Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J00||Acute nasopharyngitis [common cold]. Ayurveda Condition: Respiratory viral infection,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Anti-Viral Capsules  One capsule thrice daily, route-oral. Duration 7 to 10 days. 
Intervention  Anti-viral capsules  One Capsule twice daily. Route-Oral Duration - 7 to 10 days. 
Comparator Agent  standard of care   patients will be treated with standard of care treatment as per the PI discretion. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Subjects of either gender aged more than >18 – <65 years.
2.Subjects suffering from acute respiratory illness with one or more signs and symptoms consistent with a viral infection (eg. fever, headache, nasal discharge, fatigue, sore throat, sneezing, cough, sleep disturbance, muscle or body aches etc)
3.Onset of symptoms within 3 days from the anticipated time of randomization. Onset of symptoms is defined as the time the subject becomes aware of the first sign and/or symptom consistent with a viral infection.
4.Subject must be medically stable on the basis of physical examination, medical history and vital signs performed at screening.
5.Ability to understand and willing to give a written informed consent prior to any study-related procedures and ready to follow and in agreement to visits as per the study assessment visits
6.Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 15 days following completion of therapy.
 
 
ExclusionCriteria 
Details  1.Subjects with opportunistic infections / severe infections requiring of Anti-viral / Anti-Bacterial medication at screening.
2. Hospitalized subjects or subjects expected to be hospitalized during the study duration.
3.Individuals with acute respiratory distress.
4.Subjects suffering from severe and uncontrolled metabolic, endocrinal, cardiac/renal/liver diseases
5.Subjects with known hypersensitivity to any of the test materials or related compounds.
6. Subjects who had major surgery within the 28 days prior to randomization or have planned major surgery through the course of the study
7. Subject with a history of known or suspected chronic or acute hepatitis B or C infection
8.Women who are pregnant or breastfeeding
9.Pre-existing systemic disease necessitating long-term medications.
10.Genetic and endocrinal disorders.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in clinical symptoms (based on 0 -10 Numeric rating scale).
Time taken in resolution of clinical symptoms.
Decrease in viral load from baseline visit to end of study.
Number of people having secondary infection / complications.

 

7 -10 days 
 
Secondary Outcome  
Outcome  TimePoints 
any incidence of drug related adverse events.  7 - 10 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 2/ Phase 3 
Date of First Enrollment (India)   05/04/2021 
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)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Subject will be screened on the basis of apparent clinical symptoms of respiratory viral infection.  Once the subject is eligible for the study, the subject will be randomized  either of the treatment arms i.e,  Arm I & Arm II in 1:1 ratio.  Subjects randomized to Arm 1 will receive standard of care treatment.  Subjects randomized to Arm 2 will receive Investigational product (Anti-Viral capsule).


 
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