| CTRI Number |
CTRI/2017/03/008016 [Registered on: 06/03/2017] Trial Registered Prospectively |
| Last Modified On: |
09/03/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
In patients suffering from acute or chronic Rhino-sinusitis |
|
Scientific Title of Study
|
A Comparative, Randomized, Double Blind, Parallel Group, Placebo Controlled, Observational clinical trial study to Evaluate Efficacy and Safety
of Test Product Nasal spray containing VB-Gy (Glycerol)and HPC-Cyanidins
(HPC + Essential oils) versus 0.9% NaCl saline solution spray as Placebo in
patients suffering from acute or chronic Rhino-sinusitis.†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NEX/VIT/RS/OBS/2016 Version Number: 1.0 Date : 12/May/2016 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amit Bhatt |
| Designation |
President and CEO |
| Affiliation |
Nexus Clinical Research (India) Ltd. |
| Address |
Nexus Clinical Research (India) Ltd
32A Nexus Centre For Clinical Excellence,
Shiravane Road Service Industry Sector 1
Mumbai Pune Highway Nerul,
Navi Mumbai India
Nexus Clinical Research (India) Ltd
32A Nexus Centre For Clinical Excellence,
Shiravane Road Service Industry Sector 1
Mumbai Pune Highway Nerul,
Navi Mumbai India
Mumbai (Suburban)
MAHARASHTRA
400706
India |
| Phone |
9167243914 |
| Fax |
09167243914 |
| Email |
hbo@nexuscro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Bhatt |
| Designation |
President and CEO |
| Affiliation |
Nexus Clinical Research (India) Ltd. |
| Address |
Nexus Clinical Research (India) Ltd
32A Nexus Centre For Clinical Excellence,
Shiravane Road Service Industry Sector 1
Mumbai Pune Highway Nerul,
Navi Mumbai India
Nexus Clinical Research (India) Ltd
32A Nexus Centre For Clinical Excellence,
Shiravane Road Service Industry Sector 1
Mumbai Pune Highway Nerul,
Navi Mumbai India
Mumbai (Suburban)
MAHARASHTRA
400706
India |
| Phone |
9167243914 |
| Fax |
09167243914 |
| Email |
mangesh.khadakban@nexuscro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Bhatt |
| Designation |
President and CEO |
| Affiliation |
Nexus Clinical Research (India) Ltd. |
| Address |
Nexus Clinical Research (India) Ltd
32A Nexus Centre For Clinical Excellence,
Shiravane Road Service Industry Sector 1
Mumbai Pune Highway Nerul,
Navi Mumbai India
Nexus Clinical Research (India) Ltd
32A Nexus Centre For Clinical Excellence,
Shiravane Road Service Industry Sector 1
Mumbai Pune Highway Nerul,
Navi Mumbai India
MAHARASHTRA
400706
India |
| Phone |
9167243914 |
| Fax |
09167243914 |
| Email |
hbo@nexuscro.com |
|
|
Source of Monetary or Material Support
|
| VitroBio ZAC de Lavaur, RCS Clemont-Fd, Siren 394 63500 Issoire, France |
|
|
Primary Sponsor
|
| Name |
VITROBIO |
| Address |
ZAC de Lavaur, RCS Clemont-Fd, Siren 394 63500 Issoire, France |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NEXUS CLINICAL RESEARCH INDIA LTD |
32 A, Nexus Center For Clinical Excellence,
Sector-1, Shiravane Road, Service Industry,
Mumbai-Pune Highway, Nerul (East),
Navi Mumbai – 400 706. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sarat Kumar Behera |
Hi Tech Medical College & Hospital |
Hi Tech Medical College & Hospital
Department of Medicine Second floor Room No. 02 Division Pulmonary, Pandara Rasulgarh Bhubaneshwar Odisha 751025 Cuttack ORISSA Cuttack ORISSA Cuttack ORISSA
Cuttack
ORISSA |
09439129178
behera.saiprasanna82@gmail.com |
| Dr V Kiran Kumar |
Rajiv Gandhi Institute of Medical Sciences, Hospital |
Department of Medicine, 2nd FLoor, Srikakulam, Andhra Pradesh
Srikakulam
ANDHRA PRADESH |
09853535687
sonumansingh40@gmail.com |
| Dr S Jangid |
Sparsh Hospital & Critical Care |
Department of Medicine, A/407, Sahid Nagar, Odisha
Cuttack
ORISSA |
09861252518
sudeeppatra@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Hi Tech Medical College and Hospital Institutional Ethics Committee |
Approved |
| Rajiv Gandhi Institute of Medical Sciences (RIMS) IEC |
Approved |
| Sparsh Hospital Institutional ethics committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
In Patients Suffering From Acute or Chronic Rhino-Sinusitis., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
(0.9% NaCl Saline solution spray) |
(0.9% NaCl Saline solution spray) |
| Intervention |
Nasal spray containing Aqua, VB-Gy (glycerol based filmogen solution), and HPC-Cyanidins
|
(Hydroxypropylcellulose + Essential oils of Mantha piperita, Eucalyptus, Thymus satureioides, Rosmarinus
officinalis). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with complain of clinical manifestations of Rhino-sinusitis (RS) Major symptoms (rhinorrhea
(anterior nasal discharge), postnasal drip, nasal congestion, headache, facial pain/pressure), with a
minimum Rhino-sinusitis severity (RSS) score of 25 out of 50. |
|
| ExclusionCriteria |
| Details |
Hypersensitivity to any of the Investigational product‟s components. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in mean of overall major symptoms score (sum of all symptoms of rhinorrhea (anterior nasal
discharge), postnasal drip, nasal congestion, headache, facial pain/pressure scores) |
from baseline to 30
minute post 1st dose initiation on day 1, day 2, day 3, day 6, day 15 or day of recovery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients requiring antibiotics in Test group as compared to placebo group. |
from baseline to 30
minute post 1st dose initiation on day 1, day 2, day 3, day 6, day 15 or day of recovery |
Change in individual symptoms score of rhinorrhea (anterior nasal discharge), postnasal drip, nasal
congestion, headache, facial pain/pressure scores) from baseline to 30 minute post 1st dose initiation on
day 1, day 2, day 3, day 6, day 15 or day of recovery ( |
rom baseline to 30
minute post 1st dose initiation on day 1, day 2, day 3, day 6, day 15 or day of recovery |
|
|
Target Sample Size
|
Total Sample Size="63"
Sample Size from India="63"
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
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
16/03/2017 |
| 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="1"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This will be a Comparative, Randomized, Double Blind, Parallel group, Placebo Controlled, observational clinical trial study. The study will begin with screening evaluation. Rhino-sinusitis Severity Score Rhino-sinusitis Severity Score will be calculated by sum of all symptoms (rhinorrhea (anterior nasal discharge), postnasal drip, nasal congestion, headache, facial pain/pressure) yielding a possible range of 0 to 50, with higher score reflecting greater symptom severity. |