| CTRI Number |
CTRI/2021/04/032596 [Registered on: 07/04/2021] Trial Registered Prospectively |
| Last Modified On: |
15/04/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Acebrophylline plus Acetylcysteine tablets PMS study |
|
Scientific Title of Study
|
Prescriber Based, Post Marketing Surveillance Study (PMS) to generate safety & efficacy data of Acebrophylline + Acetylcysteine tablet |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| P & C /PMS/Acebrol_cysteine/122019_Version 1_Date_01.12.2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr SANJAY KUMAR JANGID |
| Designation |
Professor |
| Affiliation |
Hi-Tech Medical College and Hospital |
| Address |
Department of Medicine
Hi-Tech Medical College and Hospital,
Health Park, Pandara,
Bhubaneswar
Hi-Tech Medical College and Hospital,
Health Park, Pandara,Rasulgarh
Bhubaneswar
Khordha
ORISSA
751025
India |
| Phone |
06742371406 |
| Fax |
|
| Email |
drsanjaykjangid@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SAIPRASANNA BEHERA |
| Designation |
Director |
| Affiliation |
CRO Pharmatrendz Private Limited |
| Address |
PLOT NO: F/29 BJB NAGAR
Dandapat Business Centre
PLOT NO: F/29 BJB NAGAR
MEDICLINE MEDICINE STORE
Besides electricity office
Khordha
ORISSA
751014
India |
| Phone |
09439129178 |
| Fax |
|
| Email |
behera.saiprasanna82@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mamta Sharma |
| Designation |
Sr Manager DRA |
| Affiliation |
Pure and Cure Healthcare Private Limited |
| Address |
#304 Mohan Place Local Shopping Complex Block C
Saraswati Vihar
New Delhi
department of drug regulatory affairs
#304 Mohan Place
Local Shopping Complex Block C Saraswati Vihar
New Delhi
North
DELHI
110034
India |
| Phone |
|
| Fax |
|
| Email |
newdrugs@akums.net |
|
|
Source of Monetary or Material Support
|
| Pure and Cure Healthcare Private Limited
#304 Mohan Place Local Shopping Complex Block C Saraswati
Vihar New Delhi 110034 |
|
|
Primary Sponsor
|
| Name |
Pure and Cure Healthcare Private Limited |
| Address |
#304 Mohan Place Local Shopping Complex Block C Saraswati
Vihar New Delhi 110034 |
| 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 |
| Dr Sanjay Kumar Jangid |
Sparsh Hospitals and Critical Care Private Limited |
Sparsh Hospitals & Critical Care Private Limited
A/407, Back Side of Kalyan Jewelers
Sahid Nagar
Khordha
ORISSA |
8249770547
drsanjaykjangid@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sparsh Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Acebrophylline and N-Acetyl L-cysteine |
Each film coated tablets contains
Acebrophylline IP 100mg
N-Acetyl L-cysteine USP 600mg
1 tablet per day (oral) for 8 weeks |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex of age 18 to 60 years [both inclusive]
2. Willing to give written informed consent
3. All patients clinically manifesting with symptoms of Chronic obstructive pulmonary disease (COPD) |
|
| ExclusionCriteria |
| Details |
1) Patients known, or thought to be hypersensitivity to study drug
2) History of auto-immune disease
3) Concurrent use of corticosteroids
4) Any medication or indication that might point to an increased risk, associated with study participation or study drug administration or
may interfere with the interpretation of study results and, in the judgment of the study personnel, would make the subject inappropriate for inclusion
5) Participation in other clinical trials the last three months and during study participation
6) Patients with history of epilepsy, or those at risk for seizures or taking seizure drugs
7) Pregnant, lactating women or women of childbearing age who are
not using an acceptable method of birth control
8) Patients with galactose or fructose intolerance
9) Patients with severe renal impairment, including those receiving
dialysis.
10) Patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities.
11) Patients with preexisting gallbladder disease
12) Active peptic ulcer disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The aim of this prescriber based post marketing surveillance is to assess efficacy of Acebrophylline + Acetylcysteine in the actual field conditions of use. |
4 weeks from base line and at 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The aim of this prescriber based post marketing surveillance is to assess safety of Acebrophylline plus Acetylcysteine in the actual field conditions of use. |
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
07/04/2021 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Coughs are usually caused by respiratory infections, including colds or influenza, the most common causes of coughs; bronchitis, an inflammation of the mucous membranes of the bronchial tubes Coughs are usually caused by respiratory infections, including colds or influenza, the most common causes of coughs; bronchitis, an inflammation of the mucous membranes of the bronchial tubes. The aim of this prescriber based post marketing surveillance is to assess efficacy & safety of Acebrophylline + Acetylcysteine in the actual field conditions of use. All patients clinically manifesting with symptoms of COPD and who have been prescribed Adverse event reporting will be done using PMS form supplied by Medical Representative. Patients will be questioned about any adverse experience during the treatment period (Both anticipated and unexpected side effects) |