A post marketing clinical trial to assess the efficacy and safety of FDC of Diclofenac (50 mg) / Paracetamol (325 mg) / Serratiopeptidase (15 mg) in patients with postoperative dental pain after third molar surgery

A prospective, randomized, open-label, two-arm, active-controlled, parallel, multicentre, post marketing clinical trial to assess the efficacy and safety of FDC of Diclofenac (50 mg) plus Paracetamol (325 mg) plus Serratiopeptidase (15 mg) as compared to FDC of Aceclofenac (100 mg) plus Paracetamol (325 mg) plus Serratiopeptidase (15 mg) in patients with postoperative dental pain after third molar surgery

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2022/01/039531

Enrollment

Registered

2022-01-18

Start date

Unknown

Completion date

Unknown

Last updated

2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M968- Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified

Interventions

Intervention1: FDC of Diclofenac (50 mg) plus Paracetamol (325 mg) plus Serratiopeptidase (15 mg): Twice daily orally for 5 days Control Intervention1: Aceclofenac (100 mg) plus Paracetamol (325 mg) p

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and Female patients of age 18-45 years (both inclusive). 2. Patients needing extraction for impacted third molars under local anaesthesia. 3. Patients having moderate to severe pain at baseline (once surgery is over and local anaesthetic effect has subsided). 4. Patients in general good health- American Society of Anaesthesiologists (ASA) status I or II (healthy subjects based upon criteria for safe administration of outpatient conscious sedation). 5. Patients willing to give written informed consent and comply with the study procedure

Exclusion criteria

Exclusion criteria: 1. Patients with known hypersensitivity to any of the study drugs. 2. Patients with any contraindication to the study drugs. 3. Patients who are pregnant or nursing. 4. Patients with history of peptic ulcers and/or GI bleeding. 5. Patients with unusual surgical difficulty (determined from panoramic radiograph or during the actual surgery). 6. Patients developing any complication during or after surgery. Unusual surgical difficulty. 7. Patients with any other clinically significant uncontrolled systemic diseases such as gastrointestinal, respiratory, cardiovascular, renal, neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy. 8. Patients with continuing history of alcohol and/or drug abuse. 9. Participation in another clinical trial in the past 1 month prior to screening. 10. Any other reason for which the investigator feels that patient should not participate.

Design outcomes

Primary

Measure	Time frame
Sum of pain intensity difference in 6 hours (SPID6)Timepoint: Sum of pain intensity difference in 6 hours (SPID6)	—

Secondary

Measure	Time frame
1. Total pain relief in 6 hours (TOTPAR6) 2. Time to onset of analgesia 3. Time to Maximum pain relief (tMaxPR) 4. Pain relief at 48 and 96 hours (PR48 and PR96) 5. Change in swelling from baseline to end of the study 6. Requirement of rescue analgesia during the study period 7. Overall efficacy at end of studyTimepoint: 6 days	—

Countries

India

Contacts

Public ContactDr Roshan Pawar

Alkem Laboratories Limited

roshan.pawar@alkem.com9819677607

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026