| CTRI Number |
CTRI/2024/07/069797 [Registered on: 02/07/2024] Trial Registered Prospectively |
| Last Modified On: |
02/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Study to improve life quality of COPD patients using new adjuvant therapy. |
|
Scientific Title of Study
|
The outcomes of using L-glutathione and N-acetylcysteine as inhalation agents in copd patients |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prem balaji reddy |
| Designation |
Student |
| Affiliation |
Saveetha Medical College |
| Address |
Saveetha Medical College Hospital, Saveetha Nagar, Thandalam,
Chennai-602105
Chennai
TAMIL NADU
602105
India
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
8790214307 |
| Fax |
|
| Email |
prembalaji005@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Magesh kumar S |
| Designation |
Professor |
| Affiliation |
Saveetha Medical College |
| Address |
Saveetha Medical College Hospital, Saveetha Nagar, Thandalam,Chennai-602105.
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9444808797 |
| Fax |
|
| Email |
drmageshkumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prem balaji reddy |
| Designation |
Student |
| Affiliation |
Saveetha Medical College |
| Address |
Room no.1, Department of General medicine, Saveetha Medical College Hospital, Saveetha Nagar,Thandalam,
Chennai-602105
Chennai
TAMIL NADU
602105
India
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
8790214307 |
| Fax |
|
| Email |
prembalaji005@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam , Chennai, Tamilnadu , 602105 |
|
|
Primary Sponsor
|
| Name |
Dr Prem balaji reddy |
| Address |
Saveetha Medical College Hospital, Saveetha Nagar, Thandalam,
Chennai-602105
Chennai
TAMIL NADU
602105
India |
| Type of Sponsor |
Other [Self] |
|
|
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 Prem Balaji Reddy |
Saveetha Medical College Hospital |
Room no :1 , Department of General Medicine, Saveetha Medical College and Hospital, Thandalam, Chennai-602105
Kancheepuram
TAMIL NADU |
8790214307
prembalaji005@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical College and Hospital Institutional Ethics Committee |
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 |
L-GLUTATHIONE |
50mg BD , rotacap inhaler for 3 months |
| Intervention |
N-Acetyl Cysteine |
100 mg BD, rotacap inhaler for 3 months |
| Comparator Agent |
Placebo |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. patients with obstructive lung disease
|
|
| ExclusionCriteria |
| Details |
1. acute severe bronchial asthma
2. allergic rhinitis
3. bronchiectasis
4. Active pneumonia
5. Active pulmonary tuberculosis
6. Chronic kidney disease more than stage 3b
7. heart failure with reduced ejection fraction lesser than 40 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.improvement in pulmnory function tests
2.decrease in copd assessment score |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| assessment of adverse events |
3 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/07/2024 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized, double-blind, parallel-group, single-center trial comparing the efficacy of adjunctive therapy in COPD patients. The trial involves a combination therapy of glutathione (50 mg) and N-acetylcysteine (100 mg), administered twice daily via inhalation route along with standard therapy for three months, versus a placebo-controlled standardized therapy for three months. A total of 60 patients are included in the trial. The primary outcome is the improvement in pulmonary function tests before and after the trial. The secondary outcome is the assessment of adverse drug events every month for three months. |