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CTRI Number  CTRI/2020/06/025559 [Registered on: 02/06/2020] Trial Registered Prospectively
Last Modified On: 03/08/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Siddha 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Evaluation of Siddha herbal formulation, Vipro, in the management of uncomplicated respiratory infections 
Scientific Title of Study   A single centre, prospective, randomized, open labelled clinical study to evaluate the effectiveness of Siddha herbal formulation, Vipro, in uncomplicated respiratory infections 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr R Arunkumar 
Designation  Professor of Pharmacology and Vice Principal 
Affiliation  Chettinad Hospital and Research Institute, Chettinad Academy of Research and Education 
Address  Chettinad Healthcity campus, Kelambakkam, Chengalpattu DT, Old Kancheepuram DT

Kancheepuram
TAMIL NADU
603103
India 
Phone  9884212644  
Fax    
Email  arunkumarr@chettinadhealthcity.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr R Arunkumar 
Designation  Professor of Pharmacology and Vice Principal 
Affiliation  Chettinad Hospital and Research Institute, Chettinad Academy of Research and Education 
Address  Chettinad Healthcity campus, Kelambakkam, Chengalpattu DT, Old Kancheepuram DT


TAMIL NADU
603103
India 
Phone  9884212644  
Fax    
Email  arunkumarr@chettinadhealthcity.com  
 
Details of Contact Person
Public Query
 
Name  Dr R Arunkumar 
Designation  Professor of Pharmacology and Vice Principal 
Affiliation  Chettinad Hospital and Research Institute, Chettinad Academy of Research and Education 
Address  Chettinad Healthcity campus, Kelambakkam, Chengalpattu DT, Old Kancheepuram DT


TAMIL NADU
603103
India 
Phone  9884212644  
Fax    
Email  arunkumarr@chettinadhealthcity.com  
 
Source of Monetary or Material Support  
Buy Happy Marketing LLP 
 
Primary Sponsor  
Name  Buy Happy Marketing LLP 
Address  Prince Info Park, Tower B, 2nd Floor 2nd Main Road, Ambattur Industrial Estate, Chennai 600058 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Qscience Therapeutics  9 A, Maaruthi Emerald, Rajalakshmi Avenue, 4th Cross, Perungudi, Chennai – 600 096 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Tamilnadu India  Chettinad Hospital and Research Institute  Chettinad Health City campus, Rajiv Gandhi Salai, Kelambakkam
Kancheepuram
TAMIL NADU 
04447413322

arunkumarr@chettinadhealthcity.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human 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], (2) ICD-10 Condition: J029||Acute pharyngitis, unspecified, (3) ICD-10 Condition: J069||Acute upper respiratory infection,unspecified, (4) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Siddha herbal formulation, Vipro  The traditional medicinal ingredients of the product processed with essential oil from Cocus nucifera L, as base have been scientifically proven to ward off respiratory infectious diseases. It includes, Ocimum basilicum L, Curcuma longa L, Citrus lemon L, Allium sativum L, Plectranthus amboinicus Lour, Momordica charantia L, Cinnamomum verum J.Presl, Zingiber officinale Rosc and Piper nigrum L. The crude extracts of these plant parts have been proven to have anti-bacterial, anti-viral and immunomodulatory as well as anti-inflammatory properties. 
Comparator Agent  Standard treatment  symptomatic management with antipyretics and / or antihistamines and / or nasal decongestants and / or antibiotics and / or cough syrups for duration of 3 to 5 days as decided by the treating physician 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Having uncomplicated respiratory infections, at least for less than 5 days, diagnosed with clinical symptoms and signs of fever, myalgia, rhinitis, sore throat, throat pain, cough, expectoration and head ache
2. Consenting to participate in the study and sign the informed consent
 
 
ExclusionCriteria 
Details  1. Patients with uncontrolled co-morbid conditions like Diabetes mellitus, Hypertension and Bronchial asthma
2. Patients with Lower respiratory tract infections, Chronic Bronchitis, Chronic obstructive air way problems
3. Patients with significant Cardiovascular, Neurological , Psychiatric, Gastro intestinal and other system infections or disorders and malignancies
4. Hypersensitivity to the herbal ingredients in the formulations and other medications prescribed in the study
5. Pregnant and feeding mothers
6. When the patients are interviewed for selection, all those patients who come under the testing criteria for COVID-19 as per ICMR guidelines will be tested for COVID – 19 and if they are found to be positive, they will be excluded from participating in the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Reducing the severity of clinical symptoms such as fever, myalgia, rhinitis, sore throat, throat pain, cough, expectoration and head ache  Daily for 7 days 
 
Secondary Outcome  
Outcome  TimePoints 
1. Reducing the worsening of clinical symptoms
2. Reducing the complications 
Daily for 7 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/06/2020 
Date of Study Completion (India) 31/07/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
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  

This study is a single centre, prospective, randomized, open labeled clinical study to evaluate the effectiveness of Siddha herbal formulation, Vipro, towards the management of uncomplicated respiratory infection including common cold with / without fever, flu like respiratory infection, bacterial respiratory infection and unidentified SARS-CoV-2-like respiratory infection.

The patients will be enrolled at Chettinad Hospital and Research Institute, Kelambakkam, with prior informed consent.

The subjects will be grouped into three as follows.

Group 1: Standard treatment (symptomatic management with antipyretics and / or antihistamines and / or nasal decongestants and / or antibiotics and / or cough syrups for duration of 3 to 5 days as decided by the treating physician)

Group 2: Liquid, oral, poly herbal formulation ‘Vipro’,  one teaspoon of formulation, mixed in a glass of water, mixed thoroughly and swallowed after food for 7 days, for four times a day, morning, afternoon, evening and night.

             Group 3: Standard Treatment + Vipro combination will be advised as in group 1 and 2

Baseline assessment on day 0:

The patients who fulfill the inclusion and exclusion criteria will be enrolled in the study. They will be allocated to any of the treatment groups as per the randomization.  The following baseline data will be collected.

  • Demographic profile - age, gender, height, weight and BMI will be recorded
  • Blood pressure, Pulse, SpO2, Respiratory rate, Body temperature and constitutional symptoms 
  • General examination, systemic clinical examination
  • Complete blood count (with 5 ml of blood drawn) and Throat / Nasal swab for bacterial culture and sensitivity
  • Chest X ray and Nasal / Throat swab for COVID - when indicated as per the opinion of the treating physician

After the baseline assessment, the subjects will be provided with any one of the following treatments.

Group 1: Symptomatic management with antipyretics and / or antihistamines and / or nasal decongestants and / or antibiotics and / or cough syrups for duration of 3 to 5 days as decided by the treating physician

Group 2: Liquid, oral, poly herbal formulation ‘Vipro’,  one teaspoon of formulation, mixed in a glass of water, mixed thoroughly and swallowed after food for 7 days, for four times a day, morning, afternoon, evening and night.

Group 3: Combination of both treatments of group 1 and 2

Follow up assessment (days 1 to 7):

Telephonic follow up (days 1 to 7) – Reminder for medication intake (daily once), Adverse events (daily once), Clinical symptoms for improvement / worsening (daily once), body temperature and constitutional symptoms

Physical follow up (On days 4 and 7) – Checking medication compliance, Blood pressure, Pulse, SpO2, Respiratory rate, Body temperature, constitutional symptoms, adverse events, General and Systemic examination, clinical signs and symptoms

During follow up - Complete blood count (with 5 ml of blood drawn) and Throat / Nasal swab for culture and sensitivity on day 7.  Chest X ray and Throat / Nasal swab for COVID - when indicated as per the opinion of the treating physician.

If the subjects are found to deteriorate with the treatments followed, they will be withdrawn from the study and suitable alternate treatment will be provided. 

 
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