| CTRI Number |
CTRI/2024/03/063534 [Registered on: 04/03/2024] Trial Registered Prospectively |
| Last Modified On: |
23/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of N-Acetyl Cysteine in Rheumatoid arthritis |
|
Scientific Title of Study
|
A Comparative study on efficacy and safety of N-Acetyl Cysteine as an add on therapy with standard therapy in patients with Rheumatoid arthritis- A Randomised Open Labelled Prospective study. |
| 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 S Meena |
| Designation |
PG student |
| Affiliation |
Government Kilpauk Medical College |
| Address |
Department of Pharmacology,Second floor,Govt Kilpauk medical college,Barnaby Road,Kilpauk
Chennai
TAMIL NADU
600010
India |
| Phone |
8012237348 |
| Fax |
|
| Email |
tssmeena@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T Aruna |
| Designation |
Professor and Head of Department-Pharmacology |
| Affiliation |
Government Kilpauk Medical College |
| Address |
Department of Pharmacology,Second floor,Govt Kilpauk medical college,Barnaby Road,kilpauk
Chennai
TAMIL NADU
600010
India |
| Phone |
9444276923 |
| Fax |
|
| Email |
arunabala511@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr T Aruna |
| Designation |
Professor and Head of Department-Pharmacology |
| Affiliation |
Government Kilpauk Medical College |
| Address |
Department of Pharmacology,Second floor,Govt Kilpauk medical college,Barnaby Road,kilpauk
Chennai
TAMIL NADU
600010
India |
| Phone |
9444276923 |
| Fax |
|
| Email |
arunabala511@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Kilpauk Medical College and Hospital,barnaby road ,Kilpauk, chennai- 10 |
|
|
Primary Sponsor
|
| Name |
Government Kilpauk Medical College |
| Address |
Government Kilpauk Medical College and Hospital,Kilpauk |
| 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 SMeena |
Government kilpauk medical college and hospital |
Room no.2, OP block, Department of Rheumatology,
Chennai
TAMIL NADU |
8012237348
tssmeena@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Kilpauk Medical College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M057||Rheumatoid arthritis with rheumatoid factor without organ or systems involvement, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Methotrexate,
Hydroxychloroquine |
7.5 mg / week
400 mg / day for 12 weeks |
| Intervention |
N- ACETYL CYSTEINE |
600 mg twice a day for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Newly diagnosed as rheumatoid arthritis within 2 years by ACR criteria and having DAS 28-ESR score more than 3.2 who are not responding to standard therapy |
|
| ExclusionCriteria |
| Details |
Newly diagnosed Rheumatoid arthritis patients having DAS 28-ESR score less than 3.2
History of Psychiatric illness or drug abuse
History of seizure disorder.
Known case of hypersensitive to N acetyl cysteine.
Pregnant and lactating females
History of any autoimmune disease other than rheumatoid arthritis
Patient taken biological agent therapy in last 6 months
Patients taking N acetyl cysteine for any other cause. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Disease activity assessed using DAS 28 ESR score and CRP |
at baseline and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| particpants will be assessed by CBC,LFT, RFT,CRP, ESR, RF |
at baseline , 4 ,8,12, 16 weeks |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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 4 |
|
Date of First Enrollment (India)
|
11/03/2024 |
| 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 aimed to assess the safety and efficacy of N acetyl- cysteine as an add on therapy with standard therapy in patients with Rheumatoid arthritis.Patients with Rheumatoid arthritis fulfilling the inclusion criteria will be included in the study.All the participants will be assessed for DAS28 ESR score & CRP at baseline , 12 weeks and safety parameters using CBC,RFT,LFT,RF,CRP at baseline , 4,8,12,16 weeks |