| CTRI Number |
CTRI/2016/08/007153 [Registered on: 05/08/2016] Trial Registered Prospectively |
| Last Modified On: |
05/08/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
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Type of Study
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Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
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Public Title of Study
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CLINICAL TRIAL STUDY TO EVALUATE EFFICACY AND SAFETY OF FILMOGEN GLYCEROL THROAT SPRAY CONTAINING CD-CYANIDIN PLANT PREMIX WITH ESSENTIAL OIL |
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Scientific Title of Study
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“A COMPARATIVE, RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, OBSERVATIONAL CLINICAL TRIAL STUDY TO EVALUATE EFFICACY AND SAFETY OF FILMOGEN GLYCEROL THROAT SPRAY CONTAINING CD-CYANIDIN PLANT PREMIX WITH ESSENTIAL OIL VERSUS SALINE SPRAY AS PLACEBO IN THE TREATMENT OF PATIENTS SUFFERING FROM DRY COUGH.†|
| Trial Acronym |
DRY |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NEX/HER-DRY/OBS/2016, Version No 1.0, Dated 13/May/2016 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
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| 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
Mumbai
MAHARASHTRA
400706
India |
| Phone |
27714203 |
| Fax |
|
| Email |
hbo@nexuscro.com |
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Details of Contact Person
Public Query
|
| Name |
Mangesh Khadakban |
| Designation |
Manager |
| 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
Mumbai
MAHARASHTRA
400706
India |
| Phone |
27714203 |
| Fax |
|
| Email |
mangesh.khadakban@nexuscro.com |
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Source of Monetary or Material Support
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| VITROBIO
ZAC de Lavaur
63500 Issoire, France
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Primary Sponsor
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| Name |
VITROBIO |
| Address |
VITROBIO
ZAC de Lavaur
63500 Issoire, France
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| Type of Sponsor |
Research institution |
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Details of Secondary Sponsor
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| Name |
Address |
| Nexus Clinical Research |
32 A, Nexus Centre For Clinical Excellence, Shiravane Road ,Service Industry, Sector -1,
Mumbai-Pune Highway, Nerul (E), Navi Mumbai 400706
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| 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 and Hospital
Department of Medicine
Second floor Room No.
04 Pandara Rasulgarh
Bhubaneshwar Odisha
751025
Cuttack
ORISSA
Cuttack
ORISSA |
09861252518
behera.saiprasanna82@gmail.com |
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hi Tech Medical College and Hospital Institutional Ethics Committee |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
For the Treatment of dry cough., |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Comparator Agent |
Comparator placebo product: 0.9% NaCl saline spray, presented in identical 30 ml spray container. |
Comparator placebo product: 0.9% NaCl saline spray, presented in identical 30 ml spray container.
Placebo product (sprays) will be presented identical to the Active Treatment test product except for the product code. The color of the bottle, spray, cover, and the sticker print will be identical for both Test and the Placebo sprays.
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| Intervention |
Test Product: A filmogen glycerol throat spray containing CD-Cyanidin plant premix and one essential oil |
A filmogen glycerol throat spray containing CD-Cyanidin plant premix and one essential oil . |
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Inclusion Criteria
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| Age From |
8.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Both male and female, Age between 8 to 65 years old.
Patients having dry cough (less than 7 days) of any origin with related symptoms as Throat Pain, throat redness, Throat irritation/itching, (Fever if present) (absence of bronchial mucus/phlegm production)
Not under any antibacterial or antiviral treatment before recruitment.
Patients ready to abstain from using any drug (which will affect the study outcome) other than Investigational Product for the treatment of the studied condition during the study period (except in cases when patient’s condition worsens as per study physician. In this case, Study physician will decide to prescribe antibiotic, if required).
Ready to abstain from administration of any herbal or ayurvedic treatment or gargles directed to ease coughing or throat parameters, tea, coffee.
Cooperative and understanding skills.
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| ExclusionCriteria |
| Details |
Hypersensitivity/ history of allergy to any of the Investigational product’s components.
Patients who had taken any medicated confectionary, throat pastille, spray or any product with demulcent properties, any cough medicines or drugs containing antihistamines within last 72 hours prior to screening.
Patients taking medications with known cough promoting side effects (e.g., angiotensin converting enzyme inhibitors or angiotensin II receptor blockers) that in the opinion of the investigator are causing symptoms of cough
Patients with diagnosis of diseases of pneumonia, asthma, sinusitis, allergic rhinitis, as well as heart disease.
Patients who had used any local anesthetic within the past 24 hours.
Patients who have used a longer acting or slow release analgesic during the previous 24 hours.
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Centralized |
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Blinding/Masking
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Double Blind Double Dummy |
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Primary Outcome
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| Outcome |
TimePoints |
Primary Endpoint:
 Change in the dry cough severity and frequency score at 2 h after the start of treatment on day 1, day 2, day 3, day 6, day 9, day 12 and day 15 or up to complete recovery (whichever is earlier) compared to the baseline.
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Frequency score at 2 h after the start of treatment on day 1, day 2, day 3, day 6, day 9, day 12 and day 15 or up to complete recovery (whichever is earlier) compared to the baseline.
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Secondary Outcome
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| Outcome |
TimePoints |
|  Change in score of throat pain, throat irritation, throat mucosa redness, swollen throat, fever and effect on swallowing at 5 minutes and 2 h after the 1st application on the days 1, day 2, day 3, day 6, day 9, day 12 and day 15 or up to complete recovery (whichever is earlier) compared to baseline values and compared to the placebo treatment. |
Effect on swallowing at 5 minutes and 2 h after the 1st application |
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Target Sample Size
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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" |
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Phase of Trial
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N/A |
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Date of First Enrollment (India)
|
11/08/2016 |
| 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 |
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Estimated Duration of Trial
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Years="0"
Months="0"
Days="14" |
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Recruitment Status of Trial (Global)
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Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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The
aim of this study is to assess the efficacy and safety of ChSp-D
throat spray against a placebo saline spray for the treatment of patients
suffering from dry cough in a comparative, randomized, double blind, parallel
group, observational clinical trial. The effect on dry cough, throat symptom severity
scores and requirement of antibiotics will be assessed. This
will be a comparative, randomized, double blind, parallel group, observational
clinical trial study compared to Placebo. The study will begin with screening
evaluation.
After
screening, Patients satisfying all the inclusion criteria will be enrolled and
randomly allocated in 2:1 ratio as per randomization schedule to receive test
product or Comparator product (Placebo-saline solution spray). Treatments will
be allocated to patient by carrying out randomization using SAS Version 9.1.3.
Biostatistician of Nexus Clinical Research Ltd. will generate the randomization
schedule. Block Randomization methodology will be employed for generating the
list. Within the block the treatment will be distributed in the ratio of 2:1.
This study is designed to get
exploitable results in at least 42 patients in the test group and 21 patients
in the Placebo group. The main endpoint being dry cough, the patients will be
screened suffering from dry cough and related throat
symptoms. |