| CTRI Number |
CTRI/2013/10/004080 [Registered on: 18/10/2013] Trial Registered Retrospectively |
| Last Modified On: |
05/10/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Doxycycline cures non-infective-nonmalignant lung lessions. |
|
Scientific Title of Study
|
Role of doxycycline in treating different tissue lesions and thickening of lung and pleura: a pilot case based observation with different types of lesions. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IPCR/LTL/001 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Parthasarathi Bhattacharyya |
| Designation |
Principal Investigator |
| Affiliation |
Institute of Pulmocare and Research, Kolkata |
| Address |
CB-16, Sector 1, Salt Lake, Kolkata.
Kolkata
WEST BENGAL
700064
India |
| Phone |
033-23580424 |
| Fax |
033-23580424 |
| Email |
parthachest@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parthasarathi Bhattacharyya |
| Designation |
Principal Investigator |
| Affiliation |
Institute of Pulmocare and Research, Kolkata |
| Address |
CB-16, Sector 1, Salt Lake, Kolkata.
Kolkata
WEST BENGAL
700064
India |
| Phone |
033-23580424 |
| Fax |
033-23580424 |
| Email |
parthachest@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parthasarathi Bhattacharyya |
| Designation |
Principal Investigator |
| Affiliation |
Institute of Pulmocare and Research, Kolkata |
| Address |
CB-16, Sector 1, Salt Lake, Kolkata.
Kolkata
WEST BENGAL
700064
India |
| Phone |
033-23580424 |
| Fax |
033-23580424 |
| Email |
parthachest@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Institute of Pulmocare and Research |
|
|
Primary Sponsor
|
| Name |
Dr Parthasarathi Bhattacharyya |
| Address |
CB-16, Sector 1, Salt Lake, Kolkata-700064 |
| Type of Sponsor |
Other [[Non Govt Pulmonary Research Institute]] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Institute of Pulmocare and Research |
CB-16, Sector 1, Salt Lake, Kolkata-700064 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Parthasarathi Bhattacharyya |
Institute of Pulmocare and Research |
CB-16, Sector 1, Salt Lake, Kolkata-700064
Kolkata
WEST BENGAL |
033-23580424
033-23580424
parthachest@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Institute of Pulmocare & Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
with different lung lesions, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Doxycycline 100 mg |
Doxycycline 100 mg BD for body weight over 45 kg and 100 mg OD for body weight less than 45 kg.
The therapy will be continued even upto one year or till the lesion targeted disappears or get stabilized over a course of atleast 3 months measured on repeating the same investigations. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Willing to give written informed consent
2. Male/Female of age 15-75 years with lung and pleural lesion as described in protocol.
|
|
| ExclusionCriteria |
| Details |
1. active infection or malignancy will be excluded.
2. unable to meet the demand of the protocol for any reason.
3. significant abnormality in liver and renal function
4. features of chronic congestive cardiac failure (supported by echocardiography)
5. history of exacerbation in past 1 month |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to see the long term doxycycline in different variety of lung lesions without overt symptoms and/or evidence of active co presence of infection/malignancy |
Nil |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/07/2008 |
| 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="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
Tubercular pleural
effusion can lead to pleural thickening that can result in permanent
restriction defect and even thoracic skeletal deformity. The initiation and
maintenance of such thickening possibly involves the participation of matrix
metalloproteinase, a class of enzyme that plays an integral role in the
development of different tissue reactions to insults. Inhibition of matrix
metalloproteinases may help to prevent or treat pleural thickening. |