CTRI

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CTRI Number

CTRI/2024/01/062033 [Registered on: 30/01/2024] Trial Registered Prospectively

Last Modified On:

27/09/2024

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

Study on Aceclofenac plus serratiopeptidase plus paracetamol in impacted lower third molar surgery

Scientific Title of Study

Evaluation of Efficacy and safety of aceclofenac plus paracetamol plus serratiopeptidase combination after Impacted lower third molar surgery: A randomized, double blind comparison with aceclofenac plus paracetamol combination

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
Protocol No. Ipca/APSP/PIV-21, A 00, V01, 01.12.2021	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Anil Pareek
Designation	President
Affiliation	Ipca Laboratories Limited
Address	Medical Affairs and Clinical Research department, Plot 142-AB, 2nd floor Kandivli Industrial Estate, Kandivli (West) Mumbai (Suburban) MAHARASHTRA 400067 India
Phone	02266474641
Fax
Email	anil.pareek@ipca.com

Details of Contact Person
Scientific Query

Name	Dr Anil Pareek
Designation	President
Affiliation	Ipca Laboratories Limited
Address	Medical Affairs and Clinical Research department, Plot 142-AB, 2nd floor Kandivli Industrial Estate, Kandivli (West) MAHARASHTRA 400067 India
Phone	02266474641
Fax
Email	anil.pareek@ipca.com

Details of Contact Person
Public Query

Name	Nitin Chandurkar
Designation	Vice President
Affiliation	Ipca Laboratories limited
Address	Medical Affairs and Clinical Research department, Plot 142-AB, 2nd floor Kandivli Industrial Estate, Kandivli (West) Mumbai (Suburban) MAHARASHTRA 400067 India
Phone	02266474622
Fax
Email	nitin.chandurkar@ipca.com

Source of Monetary or Material Support

Ipca Laboratories Ltd. Plot No. 142-AB, Kandivli Industrial Estate, Kandivli (W) Mumbai-400067

Primary Sponsor

Name	Ipca Laboratories Limited
Address	Plot No. 142-AB, Kandivli Industrial Estate, Kandivli (W) Mumbai-400067
Type of Sponsor	Pharmaceutical industry-Indian

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study
Modification(s)

No of Sites = 34
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Neha Vyas	Ahmedabad Dental College and Hospital	Department of Oral and Maxillofacial Surgery, Ahmedabad, Gujarat Ahmadabad GUJARAT	9925205553 dr.nehavyas@gmail.com
Dr Jitendra Sharan	AIIMS Hospital Bhubaneswar	Sijua, Patrapada, Bhubaneswar, Odisha-751019 Khordha ORISSA	9968856761 dent_jitendra@aiimsbhubaneswar.edu.in
Dr Ankita Chugh	AIIMS Jodhpur	Department of Dentistry,Jodhpur,Rajasthan-342005 Jodhpur RAJASTHAN	8003996891 ankitamody@gmail.com
Dr Ajay Chhabra	AIIMS Kalyani	Department of Dentistry,AIIMS Kalyani, West Bengal Nadia WEST BENGAL	9417200001 ajay.dental@aiimskalyani.edu.in
Dr Uday Kiran Uppada	AIIMS Nagpur	Plot No:02, Sector-20, Mihan, Nagpur-441108 Nagpur MAHARASHTRA	9948885515 udaymaxfax@gmail.com
Dr Manish Raghani	All India Institute of Medical Sciences Raipur	Department of Dentistry, GE Road, Tatibandh, Raipur, Chhattisgarh-492099 Raipur CHHATTISGARH	9691562656 drmanishraghani@aiimsraipur.edu.in
Dr Vishal Halgatti	Belgavi Institute of Medical Sciencs	Dr B R Ambedkar Road, Belgavi-590001 Belgaum KARNATAKA	9448435259 vishalhalgatti@gmail.com
Dr Prasanna Kumar P	Coorg Institute of Dental Sciences	Kanjithanda Kushalappa Campus Virajpet Kodagu Karnataka Kodagu KARNATAKA	9886122780 prasannamaxface@gmail.com
Dr Vidya KC	Coorg Institute of Dental Sciences	Department of Oral and maxillofacial Surgery, KK Campus, Maggula, Virajpet-571218 Kodagu KARNATAKA	9556585362 drvidya1984@gmail.com
Dr Ajoy Kumar Shahi	Dental College Rajendra Institute of Medical Sciences	Department of Oral and Maxillofacial surgery, RIMS, Bariatu, Ranchi-834009 Ranchi JHARKHAND	9955361090 drajoyshahi@gmail.com
Dr Manisha Marathe	Dr Vasantrao Pawar Medical College Hospital and Research Centre	Vasantdada Nagar, Adgaon, Nashik-422003 Nashik MAHARASHTRA	7875002421 archiespagar@gmail.com
Dr Shallu Bansal	Geetanjali Dental and Research Institute	Department of Oral and Maxillofacial Surgery, Hiranmagri Extension, Manwakhera, Udaipur-313002 Udaipur RAJASTHAN	9116155666 drshallu23@yahoo.com
Dr Shoyeb Shaikh	Government Medical College and SSG Hospital	OPD 14, first floor, Department of Dentistry, Jail Road,Indira Avenue, Sayajigaunj, Vadodara-390001, Gujarat Vadodara GUJARAT	8980809588 drshoyebshaikh@yahoo.com
Dr Raghu K	Indira Gandhi Institute of Dental Sciences	Sri balaji Vidyapeeth University Pillaiyarkuppam-607402 Pondicherry PONDICHERRY	9043328474 dr.raghuk@gmail.com
Dr Raman Grover	Jaipur National University Institute for Medical Sciences and Research Centre	Near new RTO office, Jagatpura, jaipur-302017 Jaipur RAJASTHAN	8875522900 drramanjnu24@gmail.com
Dr R Sathish	JSS Dental College	S S Nagar, Bannimantap, Mysore Mysore KARNATAKA	9845310737 drsathish75@gmail.com
Dr Navin Shah	K M Shah Dental College and Hospital	Department of Oral and Maxillofacial Surgery, K M Shah Dental College and Hospital, Sumandeep Vidyapeeth Deemed to be University, At & Po Piparia, Ta Waghodia, Vadodara 391760 Vadodara GUJARAT	9825021681 drnavin33@yahoo.com
Dr Vinay S	Kalinga Institute of Dental Sciences	KIIT Deemed to be University Patia Khordha ORISSA	08763799695 reachvnys@gmail.com
Dr Manjunath M Vijapur	Karnataka Institute of Medical Science	Room no.11, Department of Oral and Maxillofacial Surgery, Vidyanagar, Hubballi, Karnataka-580021 Dharwad KARNATAKA	09480556564 dr.manjunathbijapur@gmail.com
Dr Vinod Birra	King George Hospital	Andhra Medical College, Maharanipeta, Visakhapatnam-530002 Visakhapatnam ANDHRA PRADESH	9963899947 drvinodbirra@gmail.com
Dr Arunesh Kumar Tiwari	King Georges Medical University	Department of Oral Maxillofacial Surgery, Lucknow-226003 Lucknow UTTAR PRADESH	8765183953 aruneshtiwari@kgmcindia.edu
Dr Tushar Ghode	Lifepoint Multispecialty Hospital	145/1, Mumbai Bangalore Highway, Near Hotel Sayaji, Wakad, Pune-411057 Pune MAHARASHTRA	9960385988 drtusharghode177@gmail.com
Dr Yusuf Chunawala	M A Rangoonwala College of Dental Sciences	Department of Pedodontics and Preventive Dentistry, Azam Campus 2390-B, Hidayatulla Rd, Camp, Pune-411 Pune MAHARASHTRA	9890325152 smileydoctor@yahoo.com
Dr Arvind R	Manipal College of Dental science and Hospital	Light House Hill Road, Manglore-575001 Dakshina Kannada KARNATAKA	9845794666 arvind.r@manipal.edu
Dr Chithra A	Manipal College of Dental science and Hospital	Department of Oral & Maxillofacial Surgery, Madhav Nagar,Manipal,Udupi-576104 Udupi KARNATAKA	9481939772 chithramds@gmail.com
Dr Amey Rathi	MGM Medical College and Hospital	Department of clinical Pharmacology and therapeutics, clinical Trial centre, N-6, CIDCO, Aurangabad, Maharashtra-431003 Aurangabad MAHARASHTRA	8698459911 ameyrathi@rediffmail.com
Dr Rajat Misuriya	MLB Medical College	Department of Dentistry, Kanpur Road, Jhansi-284128 Jhansi UTTAR PRADESH	9336380077 rajatmisuriya1@gmail.com
Dr Ashay Gokhale	MTES Sanjeevan Hospital	Plot no. 23, Off Karve Road, Erwandwane, Pune-411004 Pune MAHARASHTRA	9822338355 ashay1.research@gmail.com
Dr Subhas Chakraborty	Nil Ratan Sircar Medical College and Hospital	138, AJC Bose Road,kolkata, West Bengal-700014 Kolkata WEST BENGAL	09830181983 subhasmds@gmail.com
Dr Ramakrishna Shenoi	Ranjeet Deshmukh Dental College	Hingna road, Nagpur-440019 Nagpur MAHARASHTRA	9822220505 ramakrishna.shenoi@gmail.com
Dr Smitha Bhat	SDM college of Dental science & Hospital	SDM University, Sattur, Dharwad Karnataka-580009 Dharwad KARNATAKA	9980407192 drsmiths@gmail.com
Dr Priyanka Saini	Sparsh Hospital and Critical Care (P) Ltd	A407 behind kalyan jewellers sparsh hospital road saheed nagar Bhubaneshwar Khordha ORISSA	7205458139 saini.priyanka13@gmail.com
Dr Vivekananda M R	Sri Hasanamba Dental College and Hospital	Vidyanagara Hassan Hassan KARNATAKA	09980843531 vivekcodsperio@ymail.com
Dr Jagdish Chandra	Yenepoya Dental College	Department of Oral & Maxillofacial Surgery, Yenepoya University, Deralakatte, Mangalore Dakshina Kannada KARNATAKA	9845150871 jagdishmds@rediffmail.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 34
Name of Committee	Approval Status
Ethics Committee of MCE Society	Approved
Ethics Committee Sanjeevan Hospital	Approved
Human Research Ethics Committee	Approved
Instituitional Ethics Committee Sparsh Hospital	Approved
Institute Ethics Committee AIIMS Raipur	Approved
Institutional Ethics Committee Belgavi	Approved
INSTITUTIONAL ETHICS COMMITTEE COORG	Submittted/Under Review
Institutional Ethics Committee for Clinical Trial	Approved
Institutional Ethics Committee Jhansi	Approved
Institutional Ethics Committee JNU	Approved
Institutional Ethics Committee Jodhpur	Approved
Institutional Ethics Committee KGMU	Approved
Institutional Ethics Committee NRS Medical College	Approved
Institutional Ethics Committee on Human Research, GMC Baroda	Approved
Institutional Ethics Committee Visakhapatnam	Approved
Institutional Ethics Committee, Ahmedabad	Approved
Institutional Ethics Committee, AIIMS, Bhubaneswar	Submittted/Under Review
Institutional Ethics Committee, AIIMS, Kalyani	Approved
Institutional Ethics Committee, Dharwad	Approved
INSTITUTIONAL ETHICS COMMITTEE, HASANAMBA	Submittted/Under Review
INSTITUTIONAL ETHICS COMMITTEE, JSS Mysore	Approved
Institutional Ethics Committee, Nashik	Approved
Institutional Ethics Committee, RIMS	Approved
INSTITUTIONAL ETHICS COMMITTEE, SUMADEEP VIDYAPEETH	Approved
Institutional Ethics Committee-KIMS	Submittted/Under Review
INSTITUTIONAL HUMAN ETHICS COMMITTEE	Approved
Institutional Review Board, Coorg	Approved
KIMS Ethics committee, Hubli	Approved
Lifepoint Research-Ethics Committee	Approved
MAHE Ethics Committee, Mangalore	Submittted/Under Review
MAHE Ethics Committee, Udipi	Submittted/Under Review
MGM ETHICS COMMITTEE FOR RESEARCH ON HUMAN SUBJECT	Approved
SKCC Institutional Ethics Committee	Approved
Yenepoya Ethics Committee-2	Approved

Regulatory Clearance Status from DCGI

Status

Approved/Obtained

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: K011\|\|Impacted teeth,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Zerodol-P	Aceclofenac 100mg plus paracetamol 325mg The total duration of the treatment will be 07 days
Intervention	Zerodol-SP	Aceclofenac 100mg plus paracetamol 325mg plus serratiopeptidase 15mg Total duration of the treatment will be 07 days

Inclusion Criteria

Age From	18.00 Year(s)
Age To	45.00 Year(s)
Gender	Both
Details	1.Patient undergoing surgery for extraction of lower 3rd molar 2. Patients having first and second molars on the side of the surgery 3. Patients with ASA Grade 1 4. Patients with no history of oral surgical interventions during the past 3 weeks 5. Patients able to understand and willing to fully comply with study procedures and restrictions. 6. Patient ready to give informed consent to participate in the study

ExclusionCriteria

Details

1. Patients with Type 1 diabetes / Type 2 Diabetes
2. Patients with hypertension (SBPâ‰¥140 mmHg and/or DBP â‰¥90 mmHg)
3. Patients with genetically transmitted bleeding disorders
4. Patients with pathologic changes in teeth or the surrounding area
5. Patients with extraoral or intraoral swelling with cellulitis in the area of surgery
6. Patients with history of systemic illness
7. Patients with respiratory depression, asthma or other breathing problems
8. Patients with cardiac disease
9. Patients with previous or present gastric ulcers
10. Patients with abnormal renal function (serum creatinine â‰¥1.5 mg/dL for male and â‰¥1.4 mg/dL for female)
11. Patients with abnormal liver function (SGOT, SGPT, total bilirubin, or alkaline phosphatase >2.5 times the upper limit of normal values) or active or chronic liver disease
12. Patients with significantly abnormal counts in hematology, diseases of blood or hematopoietic organs or female patients with Hb <10 g/dL or male patients with Hb <12 g/dL
13. Patients with chronic gastroparesis, active gastrointestinal disorders (gastric and duodenal ulcer)
14. Patients with malignancy and planned radiological examinations requiring administration of contrasting agents
15. Patients with malabsorption or pancreatitis
16. Patients with dementia or other cognitive impairment prohibiting informed consent
17. Patients with known history of HIV1/HIV2/Hepatitis B or C infection or syphilis infection
18. Patients with any other clinically significant abnormalities/disease which may or may not interfere with assessment of disease under evaluation
19. Patients suspected of COVID-19 infection
20. Patients who have taken analgesic or anti-inflammatory drugs within 48 hours before surgery
21. Patients with chronic use of non-steroidal anti-inflammatory agents
22. Patients receiving concomitant medications known to have an interaction with study medications
23. Patients receiving anti-coagulant drugs
24. Patients with known history of hypersensitivity to study drugs or drugs of same chemical class or any other ingredient of the study formulations or with history of any severe allergic disease
25. Patients with other substance abuse within last 1 year
26. Patients consuming alcohol more than 21 units /week
27. Patients on another investigational agent / device or participated in a clinical trial within the last 30 days prior to enrollment.
28. Pregnant or lactating women
29. Women of childbearing potential not practicing contraception.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Pre-numbered or coded identical Containers

Blinding/Masking

Participant and Investigator Blinded

Primary Outcome

Outcome	TimePoints
1.Mean swelling of face by measuring distance in millimeters from the bottom edge of the earlobe to the midpoint of symphysia hirota (chin; DHS), distance in millimeters from bottom edge of the earlobe to external angle of mouth (horizontal distance to the corner of mouth; DHC), distance in millimeters from the palpebral outboard angle to gonial angle (verticle distance; DV)	at post-operative day 7

Secondary Outcome

Outcome	TimePoints
mean swelling (Facial measurements; DHS, DHV and DV) between treatment groups	at post-operative Day 1, 2, 3 and 5 from baseline
mean swelling (based on individual distance; DHS, DHC, and DV) between treatment groups	at post-operative Day 1, 2, 3, 5 and 7 from baseline
trismus between treatment groups	at post-operative Days 1, 2, 3, 5, and 7.
mean cheek swelling between treatment groups	at post-operative days 1, 2, 3, 5, and 7.
mean pain intensity between treatment groups	at post-operative Days 1, 2, 3, 5, and 7

Target Sample Size

Total Sample Size="556"
Sample Size from India="556"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="591"

Phase of Trial

Phase 4

Date of First Enrollment (India)

12/02/2024

Date of Study Completion (India)

25/03/2025

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="0"
Months="0"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Completed

Publication Details

None yet

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

This is a multi-centric, double-blind, parallel study. A total of 556 patients with age 18-45 years that require third molar surgery are screened for the study. There will be a pre-operative period, baseline, and post-operative (baseline) period. All patients will be given a capsule of Amoxicillin + Clavulanic acid (500mg + 125mg) thrice daily for 5 days post-operatively to prevent infection of the surgical site. Any additional antibiotics or antacids (PPIs or H2 blockers) will be prescribed at the discretion of the investigator. Patients satisfying inclusion/exclusion criteria are randomized at post-surgery into a 1:1 ratio to receive one of the following therapies twice daily for 7 days:

1. FDC of Aceclofenac 100 mg + Paracetamol 325 mg + Serratiopeptidase 15 mg tablets and matching placebo of Aceclofenac 100 mg + Paracetamol 325 mg FDC tablets

2. FDC of Aceclofenac 100 mg + Paracetamol 325 mg tablets and matching placebo of Aceclofenac 100 mg + Paracetamol 325 mg + Serratiopeptidase 15 mg FDC tab