| CTRI Number |
CTRI/2026/01/100218 [Registered on: 02/01/2026] Trial Registered Prospectively |
| Last Modified On: |
07/07/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing the effect of low-cost and branded pain relief medicines in patients with dental pain |
Scientific Title of Study
Modification(s)
|
Evaluation of Safety and Efficacy of Generic Versus Branded Generic Formulations of Ibuprofen and Aceclofenac-Paracetamol in Odontogenic Pain: A Randomized Clinical Trial |
| 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 Bala Ashwathy R M |
| Designation |
Postgraduate |
| Affiliation |
SRM Medical College Hospital & Research Centre, SRM Institute of Science & Technology (SRMIST) |
| Address |
Department of Pharmacology, SRM Medical College Hospital & Research Centre, Faculty of Medicine and Health Sciences, SRM Institute of Science & Technology, Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
8939247449 |
| Fax |
|
| Email |
birlabala@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sangeetha Raja |
| Designation |
Professor |
| Affiliation |
SRM Medical College Hospital & Research Centre, SRM Institute of Science & Technology (SRMIST) |
| Address |
Department of Pharmacology, SRM Medical College Hospital & Research Centre, Faculty of Medicine and Health Sciences, SRM Institute of Science & Technology, Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9176630021 |
| Fax |
|
| Email |
sangeeta1@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bala Ashwathy R M |
| Designation |
Postgraduate |
| Affiliation |
SRM Medical College Hospital & Research Centre, SRM Institute of Science & Technology (SRMIST) |
| Address |
Department of Pharmacology, SRM Medical College Hospital & Research Centre, Faculty of Medicine and Health Sciences, SRM Institute of Science & Technology, Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
8939247449 |
| Fax |
|
| Email |
birlabala@gmail.com |
|
|
Source of Monetary or Material Support
|
| Infrastructure and logistic support provided by SRM Medical College Hospital & Research Centre, Faculty of Medicine and Health Sciences, SRM Institute of Science & Technology, Kattankulathur, India |
|
|
Primary Sponsor
|
| Name |
SRM Medical College Hospital & Research Centre |
| Address |
SRM Institute of Science & Technology,
SRM Nagar, Kattankulathur, Chengalpattu, Tamil Nadu, India - 603203 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Bala Ashwathy R M |
SRM Medical College Hospital and Research Centre |
Dental Outpatient Department (OPD), Department of Dentistry,
SRM Institute of Science & Technology,
SRM Nagar, Kattankulathur,
Chengalpattu District,
Tamil Nadu, India.
Kancheepuram
TAMIL NADU |
8939247449
birlabala@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, SRM Medical College Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K044||Acute apical periodontitis of pulpal origin, (2) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Branded generic - ACECLOFENAC-PARACETAMOL |
Group 4 participants will receive Branded-generic formulation of Aceclofenac 100mg + Paracetamol 325mg combination oral tablets twice daily (BD) for 5 days as prescribed for management of odontogenic pain |
| Comparator Agent |
Branded generic - IBUPROFEN |
Group 2 participants will receive Branded-generic formulation of Ibuprofen 400mg oral tablets twice daily (BD) for 5 days as prescribed for management of odontogenic pain |
| Intervention |
Jan Aushadhi - IBUPROFEN |
Group 1 participants will receive Jan Aushadhi supplied Ibuprofen 400mg oral tablets twice daily (BD) for 5 days as prescribed for management of odontogenic pain |
| Intervention |
Jan Aushadhi- ACECLOFENAC-PARACETAMOL |
Group 3 participants will receive Jan Aushadhi supplied Aceclofenac 100mg + Paracetamol 325mg combination oral tablets twice daily (BD) for 5 days as prescribed for management of odontogenic pain |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients diagnosed with Pulpitis and Acute apical periodontitis having Visual Analog Scale pain score more than or equal to 4 at baseline
|
|
| ExclusionCriteria |
| Details |
1.Patients requiring surgical intervention under general anaesthesia or other medications except NSAID for treatment of dental pathology
2.Patients with odontogenic -like pain (e.g., referred pain, neuralgia) without a dental pathology
3.Patients with past history of allergic reactions or hypersensitivity to NSAIDs
4.Pregnant or Lactating women
5.Patients currently on chronic NSAIDs (for cardiovascular disease), systemic corticosteroids, opioids, anticoagulants, or immunosuppressants within last 2 months
6.History of Gastrointestinal disorders (e.g. Peptic ulcer disease, bleeding), bronchial asthma, or respiratory distress
7.History of using any NSAID or antibiotics within 2 weeks before the initial OPD visit
8.History of alcohol use disorder or substance abuse
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The mean change in Visual Analog Scale score |
Baseline, Day 3 and Day 5 |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Change in salivary Prostaglandin E2 (PGE2) levels |
Baseline (Day 0) and post-treatment (Day 5) |
| Change in serum C-reactive protein (CRP) |
Baseline (Day 0) and post-treatment (Day 5) |
| Incidence and severity of adverse drug reactions |
During treatment period up to Day 5 |
| Changes in hepatic, renal and hematological parameters |
Baseline and Day 5 |
| Cost effectiveness and incremental cost effectiveness analysis |
At end of the treatment period |
| Cost benefit cost minimization and budget impact analysis |
At end of the study |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
20/01/2026 |
| 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) |
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 - NO
|
|
Brief Summary
|
This is a prospective randomized clinical trial designed to evaluate the safety efficacy and cost effectiveness of Jan Aushadhi supplied non steroidal anti inflammatory drugs compared with branded generic formulations in patients with odontogenic pain. A total of one hundred and sixty participants will be randomly allocated into four groups. Participants will receive either Jan Aushadhi or branded generic ibuprofen or aceclofenac paracetamol combination as per standard dosing for five days. Pain intensity will be assessed using the Visual Analog Scale at baseline and Day 5 of treatment. Inflammatory biomarkers including salivary prostaglandin E2 salivary nitrite serum C reactive protein and salivary total protein will be measured before and after treatment. Safety will be evaluated by monitoring adverse drug reactions and changes in hepatic renal and hematological parameters. A pharmacoeconomic analysis will be performed to compare cost effectiveness cost benefit and budget impact of Jan Aushadhi and branded generic formulations in the management of odontogenic pain. |