| CTRI Number |
CTRI/2025/05/086686 [Registered on: 09/05/2025] Trial Registered Prospectively |
| Last Modified On: |
02/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Can N-Acetylcysteine prevent liver problems in TB patients? |
|
Scientific Title of Study
|
Role of N-Acetylcysteine as prophylactic drug for Antitubercular drug induced hepatitis |
| 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 Neha Sood |
| Designation |
Junior Resident |
| Affiliation |
PGIMER Chandigarh |
| Address |
Department of Internal Medicine, 4th floor, Nehru Hospital, PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9882189350 |
| Fax |
|
| Email |
nehasood.118@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Atul Saroch |
| Designation |
Additional Professor |
| Affiliation |
PGIMER Chandigarh |
| Address |
Department of Internal Medicie,4th floor, Nehru Hospital, PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7289873798 |
| Fax |
|
| Email |
atulsaroch@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha Sood |
| Designation |
Junior Resident |
| Affiliation |
PGIMER Chandigarh |
| Address |
Department of Internal Medicine, 4th floor, Nehru Hospital, PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9882189350 |
| Fax |
|
| Email |
nehasood.118@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Internal Medicine,4th floor, Nehru Hospital, Post Graduate Institute of Medical Education and Research, Chandigarh, Pin code-160012. Country-India |
|
|
Primary Sponsor
|
| Name |
Department of Internal Medicine |
| Address |
4th floor, Nehru Hospital, Post Graduate Institute of Medical Education and Research, Chandigarh, Pin code-160012, Country- India |
| Type of Sponsor |
Government medical college |
|
|
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 Neha Sood |
Post Graduate Institute of Medical Education and Research, Chandigarh |
Department of Internal Medicine,4th floor, Nehru Hospital
Chandigarh
CHANDIGARH |
09882189350
nehasood.118@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, PGIMER, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A15-A19||Tuberculosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
N-Acetylcysteine with standard antitubercular therapy |
N-Acetylcysteine at a dose of 600 mg two oral tablets daily for one month upon clinicoradiological and or microbiological evidence of tuberculosis along with standard of care antitubercular drugs. |
| Comparator Agent |
Standard antitubercular therapy. |
The comparator arm will receive standard antitubercular therapy. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Newly diagnosed TB.
2. Started on standard dose of anti-TB drugs regimen.
3. Patient with normal hepatic transaminases and bilirubin values at baseline.
4. Patient with clinical and radiological and/or microbiological evidence of tuberculosis |
|
| ExclusionCriteria |
| Details |
1. Patient with age less than 18 years.
2. Previous TB infection or Multi Drug Resistant TB.
3.Not willing to consent for the study.
4. Hypersensitivity to N-Acetylcysteine.
5. Pregnant females.
6. Patients with Glasgow Comma Scale score less than 8.
7. Patients with deranged hepatic transaminases and or bilirubin at baseline.
8. Patient with peptic ulcer disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To calculate the difference in incidence of DILI in both treatment arms.
|
2 weeks,4 weeks and 8 weeks and if participant becomes symptomatic for ATT induced hepatitis. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3 |
|
Date of First Enrollment (India)
|
15/05/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - In medical journals.
- For how long will this data be available start date provided 23-04-2025 and end date provided 13-12-2029?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Drug Induced Liver Injury is a very common phenomenon that occurs after anti-tubercular therapy. The role of N Acetylcysteine in treatment of acetaminophen induced hepatitis is well established in medical literature. However, role of N-Acetylcysteine in ATT induced hepatitis is still under investigation with some studies suggestive of benefit and others suggesting no benefit as a prophylactic protective agent in ATT induced hepatitis.
Cilinico-radiological and/or microbiologically diagnosed tuberculosis patients will be randomly divided into two subgroups with one subgroup receiving standard treatment and the other subgroup receiving standard treatment and NAC at an oral dose of 600 mg BD for one month.
Serum LFT will be monitored at 2 weeks, 4 weeks and at 8 weeks and/or if the patient becomes symptomatic for ATT induced hepatitis in both the groups, to see the protective effects of NAC.
The role of N Acetylcysteine in preventing ATT induced hepatitis has not been well explored in the medical literature. This study aims to explore whether N Acetylcysteine can be used as a protective agent to prevent ATT induced hepatitis.
Incidences of ATT-DILI will be calculated in both the treatment arms. Subgroup analysis of incidences will be performed based on type-Pulmonary and/or Extra-Pulmonary tuberculosis |