| CTRI Number |
CTRI/2020/07/026434 [Registered on: 08/07/2020] Trial Registered Prospectively |
| Last Modified On: |
23/02/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical trial on Ayurvedic product for viral and bacterial infections |
|
Scientific Title of Study
|
A prospective, single arm, multicentric clinical study to evaluate the safety and efficacy of
HERBOVIR syrup in subjects with upper respiratory tract infection along with standard of care |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Herbovir/CT/2020 Version 1.0 dated 10th June 2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sri HSrinivas |
| Designation |
C.E.O |
| Affiliation |
Venkat Pharma |
| Address |
Venkat Pharma
130/122 &15/6, Hallimala,
Sri Rama Hills Road,
Ramanagara,
Karnataka-562159
Bangalore Rural
KARNATAKA
562159
India |
| Phone |
9448080317 |
| Fax |
|
| Email |
sreenivas.drugs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sri HSrinivas |
| Designation |
C.E.O |
| Affiliation |
Venkat Pharma |
| Address |
Venkat Pharma
130/122 &15/6, Hallimala,
Sri Rama Hills Road,
Ramanagara,
Karnataka-562159
KARNATAKA
562159
India |
| Phone |
9448080317 |
| Fax |
|
| Email |
sreenivas.drugs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sri HSrinivas |
| Designation |
C.E.O |
| Affiliation |
Venkat Pharma |
| Address |
Venkat Pharma
130/122 &15/6, Hallimala,
Sri Rama Hills Road,
Ramanagara,
Karnataka-562159
KARNATAKA
562159
India |
| Phone |
9448080317 |
| Fax |
|
| Email |
sreenivas.drugs@gmail.com |
|
|
Source of Monetary or Material Support
|
| VENKAT PHARMA
130/122 &15/6, Hallimala,
Sri Rama Hills Road,
Ramanagara,
Karnataka-562159 |
|
|
Primary Sponsor
|
| Name |
VENKAT PHARMA |
| Address |
130/122 &15/6, Hallimala, Sri Rama Hills Road, Ramanagara, Karnataka-562159 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrShubarani |
Sri Venkateshwara Hospitals |
First floor OPD room no 3
No 27 29th Main road rashtra Kuvempu nagara BTM 2nd stage BTM Layout Bangalore 560076
Bangalore Rural
KARNATAKA |
9449453674
dr.shubharani111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Venkateshwara Hospitals-Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J205||Acute bronchitis due to respiratory syncytial virus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HERBOVIR Syrup |
Dose : 10 ml of HERBOVIR syrup three times daily in the
morning (After Breakfast), after noon (Post lunch) and in night after dinner
Route: Orally
Duration: Three times daily
Duration: 7 days |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects aged 18-65 years of age and of either sex
2. subjects who were disposed to give consent to the study and willing for follow-up
3. Subjects who are willing to sign ICF
4. Clinical signs and symptoms of an URTI with a duration of up to 24 hours accompanied with or without fever 37.5 C (axillary body temperature) or higher
5. At least 1 of 3 types of URTI symptoms – Nasal (plugged nose, runny nose, sneezing), Pharyngeal (scratchy throat, sore throat, pharyngeal hyperaemia), Cough (ordinary cough without suspicion of acute lower respiratory tract disease). At least 1 of 5 general symptoms – feeling tired, weakness, body ache, irritable or whiney,or less active
6. Not be in need of hospitalized medical care at screening
|
|
| ExclusionCriteria |
| Details |
1. Age less than 18 years and more than 65 years
2. Pregnancy
3. Severe or complicated course of URTI.
4. Signs of acute lower respiratory tract disease.
5. Daily use of antibiotics, steroids and cytotoxic agents.
6. Any uncontrolled systemic disease, infection
7. Those with serious Cardiovascular, Cerebrovascular, Respiratory, Liver or Renal disease• or any other disorder
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change from baseline in the Wisconsin Upper Respiratory Symptom Survey |
Day 0 to Day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Adverse events (AEs),
• frequency and severity Number of subjects who discontinue study due to adverse events
• Changes in vital parameters and laboratory investigations.
|
Day 0 to Day 7 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
13/07/2020 |
| 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="4"
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
|
Earlier clinical studies using Nutraceutical ingredients of herbal origin have demonstrated
significant improvement in Immunity. HERBOVIR is an herbal preparation containing multiple
herbal extracts known to boost immunity. These herbals are used for various infectious ailments
from many centuries and with abundant literature evidences
|