| CTRI Number |
CTRI/2015/01/005475 [Registered on: 29/01/2015] Trial Registered Retrospectively |
| Last Modified On: |
14/05/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Combination of two drugs in tuberculosis treatment |
|
Scientific Title of Study
|
Study on bio
enhancer in the treatment of tuberculosis with Rifampicin : An evidence
based update - A Randomized Controlled Tial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr A D Nageswari |
| Designation |
Professor and Head |
| Affiliation |
Department of Pulmonary Medicine |
| Address |
SRM Medical College Hospital and Research Center, SRM University, Kattankulathur
Kancheepuram
TAMIL NADU
603 203
India |
| Phone |
|
| Fax |
|
| Email |
dradnageswari@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Devarajan |
| Designation |
Professor |
| Affiliation |
Department of Pulmonary Medicine |
| Address |
SRM Medical College Hospital and Research Center, SRM University, Kattankulathur
Kancheepuram
TAMIL NADU
603 203
India |
| Phone |
09381206124 |
| Fax |
|
| Email |
devarajmail@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
MG Rajanandh |
| Designation |
Research Scholar |
| Affiliation |
Department of Pharmacy Practice |
| Address |
SRM College of Pharmacy, SRM University
Kancheepuram
TAMIL NADU
603 203
India |
| Phone |
07598464723 |
| Fax |
|
| Email |
mgrpharm@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pulmonary Medicine, SRM Medical College Hospital and Research Center, SRM university |
|
|
Primary Sponsor
|
| Name |
Department of Pulmonary Medicine |
| Address |
SRM Medical College Hospital and Research Center, SRM university |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr K Ilango |
Dean, ISISM, SRM University |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr AD Nageswari |
Department of Pulmonary Medicine |
SRM Medical College Hospital and Research Center, SRM Nagar, Potheri, 603 203.
Kancheepuram
TAMIL NADU |
9940044571
dradnageswari@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
New sputum positive patients , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Patients in intervention group will be treated with Risorine kit |
(one Risorine capsule [Rifampicin 200mg + Isoniazid 300mg + Piperine 10mg] + one tablet of Ethambutol 800mg + two tablets of Pyrazinamide 750mg)for a period of six months. |
| Comparator Agent |
Usual care group patients will be treated with standard regimen |
Rifampicin 450mg + Isoniazid 300mg + one tablet of Ethambutol 800mg + two tablets of Pyrazinamide 750mg for a period of six months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient who is willing to give informed consent and sputum positive patient |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women and Patient who is unwilling to participate in the trial |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sputum conversion rate, improvement in lung function, chest x ray |
one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in QoL and cognitive function |
6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/08/2013 |
| 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="1"
Months="4"
Days="7" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Rifampicin containing fixed-dose
combinations are the currently approved treatments against TB in India and world
over. Rifampicin is a potent drug to fight TB but it has some unpleasant
side-effects that often forces the patients discontinue with the medicine. Risorine
is a combination of currently used antitubercular drugs isoniazid and
rifampicin mixed with a new ingredient piperine (an extract of black pepper). The
combination tablet uses only 200 mg of rifampicin instead of 450 mg, but
maintains the same efficacy and therefore reduces the need for high doses. However there is lack of evidence for Risorine in south Indian population. The present study will be an evidence based report. |