| CTRI Number |
CTRI/2011/05/001768 [Registered on: 27/05/2011] Trial Registered Retrospectively |
| Last Modified On: |
31/05/2011 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Trial to compare efficacy of a polyherbal ayurvedic formulation “Dabur Honitus” versus “Standard Allopathic Formulation” for symptomatic relief of acute non productive cough and throat irritation |
|
Scientific Title of Study
|
A Multicentre Double Blind Parallel Group two Arm Randomized Clinical Study To Evaluate The Safety And Efficacy Of Dabur Honitus Syrup Versus Benadryl Cough Formula Syrup For Symptomatic Relief Of Acute Non Productive Cough And Throat Irritation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DRDC/IIPS/Hon/10 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vaijayanti Gaikwad |
| Designation |
Consultant Investigator |
| Affiliation |
Standev Research Pvt. Ltd. |
| Address |
A1-104, Jagruti C.H.S,Kajupada, Barvenagar, Ghatkopar,(West) Munbai
Mumbai
MAHARASHTRA
400086
India |
| Phone |
09769660448 |
| Fax |
|
| Email |
drvag1069@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Satyendra Kumar |
| Designation |
Reserach Scientist |
| Affiliation |
Dabur India Ltd. |
| Address |
Dabur Research and Development Center
Dabur India Ltd.
Plot No. 22, Site IV
Sahibabad -201010
Ghaziabad (UP) INDIA
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
09891253516 |
| Fax |
|
| Email |
satyendra.kumar@dabur.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak Deshmukh |
| Designation |
Senior Clinical Research Associate |
| Affiliation |
inVentiv International Pharma Services (IIPS) |
| Address |
inVentiv International Pharma Services (IIPS)
B-101, Hamilton, Hiranandani Estate, Off. Ghodbunder Road
Thane(West)
Mumbai
MAHARASHTRA
400 607
India |
| Phone |
02267486011 |
| Fax |
02267486009 |
| Email |
ddeshmukh@inventivinternational.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dabur India Ltd |
| Address |
Dabur Research and Development Center
Dabur India Ltd.
Plot No. 22, Site IV
Sahibabad -201010
Ghaziabad (UP) INDIA |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jaideep Joshi |
Dr. Jaideep Joshi Clinic |
Gaikwad Chawl,
Chirag Nagar,
Behind Raymond,
Pokhran Road, No-2,
Thane (W), 400 606
Mumbai
MAHARASHTRA |
09820775115
drjaideepjoshi@hotmail.com |
| Dr Kulkarni |
Dr. Kulkarnis Clinic |
7,Vighnahar Bldg,(Opposite Swastik Chember)
R.M. Street,Mandvi,Koliwada
Mumbai
MAHARASHTRA |
09867813460
abk2808@gmail.com |
| Dr Umesh Deshpande |
Dr. Umesh Deshpande Clinic |
M1/1 Best Staff Quarters,
Near Best Bus Depot,
Ghatkopar (E)
Mumbai
MAHARASHTRA |
09594286691
dr.umeshdeshpande@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Clinical Ethics Forum |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients with acute non productive
cough and throat irritation for less than 1
week duration and age range is 18 - 65 years, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Benadryl Cough Formula Syrup |
Benadryl Cough Formula Syrup(Dose, duration and frequency of the same are 10 ml ( 2 teaspoonful) orally 4 times a day for a period of 3 days) |
| Intervention |
Honitus Syrup |
Ayurvedic Formulation: Dose, duration and frequency of the same are 10 ml ( 2 teaspoonful) orally 4 times a day for a period of 3 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with H/O acute non productive cough and throat irritation for less than 1
week duration
2. Males and Females between 18-65 years age.
3. Patients who in the opinion of the Investigator will be able to comply with the
study requirements.
4. Patients with a cough score of 0, 1 or 2 during day time
5. Patients willing and able to provide signed informed consent form prior to any
study related procedures. |
|
| ExclusionCriteria |
| Details |
1. Patients with H/O lower respiratory tract infections such as Pneumonia,
Tuberculosis, Bronchitis, Whooping cough.
2. Patients with H/O Chronic Obstructive Pulmonary Diseases/Asthma
3. Patients with H/O underlying lung pathology such as lung abscess, cystic fibrosis.
4. Patients with known hypersensitivity to ingredients of Investigational Products
5. Patients with clinical suspicion of any systemic bacterial infection.
6. Patients with H/O Myocardial Infarction (MI) within 4 weeks prior to enrollment
7. Patients with immediate life threatening diseases such as pre-existing
cardiovascular, liver or neoplastic disease.
8. Patients with Hypertension on Angiotensin-converting enzyme (ACE) inhibitors.
9. Alcohol, smoke and drug abusers will be excluded. Occasional users of cigarettes
and alcohol may pariticpate in the study as per the investigator’s discretion. Such
participants should be instructed from restricting the use of cigarettes / alcohol
during the study participation period.
10. Patients participating in any other clinical trial.
11. Pregnant or lactating females.
12. Patients who have received any immunosuppressant, Sedative, Hypnotic or
Tranquilizer 14 days prior to enrollment.
13. Patients who have received any Anti Histaminics, Cough suppressants ,
Mucolytics , Expectorants or Antibiotics 3 days prior to enrollment.
14. Any other condition due to which patients are deemed to be unsuitable by the
Investigator for reason (s) not specifically stated in the exclusion criteria.
15. Patients with H/O Parkinson’s disease who are on Mono Amine Oxidase
Inhibitors (MAO) inhibitors.
16. Any psychiatric illness which may impair the ability to provide written informed
consent. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes in day and night frequencies of cough from baseline on a 6 point scale in
patients with acute non- productive cough receiving therapy over a period of 3
days and Change in throat irritation on a 5 point scale from 0-4 over a treatment period of
3 days |
Changes in day and night frequencies of cough from baseline on a 6 point scale in
patients with acute non- productive cough receiving therapy over a period of 3
days and Change in throat irritation on a 5 point scale from 0-4 over a treatment period of
3 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time to relief from cough and throat irritation on a 5 point scale for first morning dose over a treatment period of 3 days, Duration of relief from symptoms on a 5 point scale for first morning dose over a treatment period of 3 days, Measure of drowsiness on a 2 point scale and Physician’s global assessment of efficacy on a 5 point scale |
Time to relief from cough and throat irritation on a 5 point scale for first morning dose over a treatment period of 3 days, Duration of relief from symptoms on a 5 point scale for first morning dose over a treatment period of 3 days, Measure of drowsiness on a 2 point scale and Physician’s global assessment of efficacy on a 5 point scale |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/03/2011 |
| 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="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Result s of the study of this clinical Trial may be used for publishing scientific papers and
data.
All the data generated on the trial will be exclusive property of sponsor; and no
publication can be done without sponsor’s written approval. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a multicenter, double blind; two arm randomized, parallel group clinical study to evaluate the safety and efficacy of a polyherbal formulation Dabur Honitus versus Standard Allopathic Formulation for symptomatic relief of acute non productive cough and throat irritation. The study will be conducted across 3 centers in India. Approximately 110 subjects will be enrolled, 55 receiving the study drug and 55 receiving the reference comparator drug. Males and females between 18-65 years with acute non productive cough and throat irritation of less than 1 week duration and meeting the selection criteria will be enrolled. Screening/baseline procedures will include medical history, physical examination and vital signs. Assessment for clinical signs and symptoms, vitals and Adverse Events will be done at every follow up visit on Day 2, Day 3 and Day 4 post treatment. Response to treatment will be measured by change in frequency of cough and throat irritation from the baseline value to end of 3day treatment in both the treatment arms. |