| CTRI Number |
CTRI/2017/12/010804 [Registered on: 07/12/2017] Trial Registered Prospectively |
| Last Modified On: |
10/08/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Phlogam and Disperzyme use for reducing pain and swelling after small surgery |
|
Scientific Title of Study
|
A multicentre, randomized, assessor blind, active controlled, comparative, phase IV study to assess the safety and efficacy of two fixed dose combinations (FDC) formulations of trypsin BP 48/96mg plus bromelain 90/180 plus Rutoside trihydrate BP 100/200 mg viz Phlogam and Disperzyme in post-operative inflammation in subjects undergoing minor surgery and dental procedures |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AKS_PHLOG_17_01, ver 1, dated 23 May 17 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hemant Dhusia |
| Designation |
Prof and Head Dept of Dentistry and Maxillofacial Surgery |
| Affiliation |
LTM Medical college and General Hospital |
| Address |
Department of Dentistry
LTMMC & LTMGH
Sion,
Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
91-9821474444 |
| Fax |
|
| Email |
drdhusia@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ganesh Divekar |
| Designation |
Head Clinical Research and Pharmacovigilance |
| Affiliation |
Bharat Serums and Vaccines Ltd |
| Address |
Bharat Serums and Vaccines Ltd., 17th floor, Hoechst House,
Nariman point, Mumbai
Mumbai
MAHARASHTRA
400021
India |
| Phone |
022-4503456 |
| Fax |
022-45043200 |
| Email |
ganesh.divekar@bharatserums.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ganesh Divekar |
| Designation |
Head Clinical Research and Pharmacovigilance |
| Affiliation |
Bharat Serums and Vaccines Ltd |
| Address |
Clinical Research and Pharmacovigilance department, room no. 18,
Bharat Serums and Vaccines Ltd., 17th floor, Hoechst House,
Nariman point, Mumbai
Mumbai
MAHARASHTRA
400021
India |
| Phone |
022-4503456 |
| Fax |
022-45043200 |
| Email |
ganesh.divekar@bharatserums.com |
|
|
Source of Monetary or Material Support
|
| Bharat serums and Vaccines Ltd. 17th floor Hoechst House Nariman Point Mumbai 400021 |
|
|
Primary Sponsor
|
| Name |
Aksigen Hospital Care |
| Address |
81/A, 8th Floor, Mittal Chambers,
Nariman Point, Mumbai-400021,
India.
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Bharat Serums and Vaccines Ltd |
17th floor, Hoechst House,
Nariman point, Mumbai |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajesh Kumar Prajapati |
Ajanta Research Centre |
Ajanta Hospital & IVF Centre
765, ABC Complex Kanpur road Alambagh lucknow 226005
Lucknow
UTTAR PRADESH |
9559782773
dr.rajeshkgmu@gmail.com |
| Dr Girish Bakhshi |
Grant Medical College & J.J. Group of Hospitals |
“Department of Surgery†J Marg, Nagpada-Mumbai Central, Off Jijabhoy Road, Mumbai
Mumbai
MAHARASHTRA |
9909032354
gdbakhshi@gmail.com |
| Dr MI Uppin |
KLES Dr. Phrabhakar Kore Hospital and Medical Research Centre |
Department of Surgery Nehru Nagar J.N Medical college campus Belgaum 590010
Belgaum
KARNATAKA |
7353340479
jay.45appu@gmail.com |
| Dr Shashank Tiwari |
KRM Hospital and Research Centre |
Depart of Dentistry, 3/92-93, Vijayant Khand, Gomti Nagar, Lucknow-22603, Uttar Pradesh, India
Lucknow
UTTAR PRADESH |
9838172269
drs.tiwari@hotmail.com |
| Dr Hemant L Dhusia |
Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College |
Department of Dentistry, OPD No-22, Second floor, Main OPD building, Dr. Babasaheb Ambedkar Road, Sion (West), Mumbai -
Mumbai
MAHARASHTRA |
9821474444
drdhusia@hotmail.com |
| Dr Girish H R |
Rajalakshmi Hospital |
#21/1, Lakshmi Pura Main road, Vidyaranyapura Post Bangalore- 560097
Bangalore
KARNATAKA |
98455516613
girirudra@yahoo.co.in |
| Dr Abhay Kulkarni |
Rajiv Gandhi Medical College and Hospital |
Department of Orthopedics, Kalwa Thane
Thane
MAHARASHTRA |
9821089952
dr.abhay.k.24@gmail.com |
| Dr Pratik Vinchhi |
Shivam Hospital |
C-4 Satyanarayan Society, Joshodanagar Char rasta Maninagar east ahmedabad 382445
Ahmadabad
GUJARAT |
9909032354
pratikdevanshzarana@gmail.com |
| Dr Shrihari Dhorepatil |
Shree hospital |
Siddharth Mansion Nagar road pune 411006
Pune
MAHARASHTRA |
9822040769
sdhorepatil@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Dr Dhorepatil S Abaji -Ethics committee of Shree Hospital |
Approved |
| Dr. GBakhshi IEC -GMC JJ group of Hospitals |
Approved |
| Dr. GirishHR Rajalakshmi Hospital Institutional Ethics Committee |
Approved |
| Dr. Kulkarni Ethics committee Rajiv Gandhi Medical college |
Approved |
| Dr. MI Uppin Institutional Ethics Committee, KLES |
Approved |
| dr. Pratik Vinchhi Shivam Ethics Committee |
Approved |
| Dr. R Prajapati Institutional Ethics Committee Ajanta Hospital IEC-ARC |
Approved |
| Institutional Ethics Committee-Human Research- LTMMC & LTMGH |
Approved |
| KRM Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Patients with post operative inflammation who have undergone minor surgical procedures, as Day Care surgery under local or regional blocks, with or without sedation including dental procedures, (1) ICD-10 Condition: T80-T88||Complications of surgical and medical care, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Disperzyme |
contains
Trypsin B.P. 96 mg
Bromelain 180 mg
Rutoside trihydrate B.P. 200 mg
1 tablet three times a day for 7 days |
| Intervention |
Phlogam® |
contains
Trypsin B.P. 48 mg
Bromelain 90 mg
Rutoside trihydrate B.P. 100 mg
2 tablets - three times a day for 7 days
|
| Comparator Agent |
Serratiopeptidase |
Serratiopeptidase, 10 mg 3 times daily for 7 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects who have undergone one of the following (but not limited to) surgical procedures, as Day Care surgery under local or regional blocks, with or without sedation:
1.1 Minor oral surgeries (e.g. tooth extraction)
1.2 Toe nail excision
1.3 Lipoma excision
1.4 Sebaceous cyst excision
1.5 Warts excision
1.6 Corn excision
1.7 Ganglion excision
2. Subject is otherwise healthy and medically stable, judged by medical history, physical examination, and vital signs’ examination performed post-surgery.
3. Subject able to understand the purpose of the study, and willing to comply with the study procedures, in the opinion of the investigator
4. Subject willing to provide written informed consent as per current requirement of health regulatory authority.
|
|
| ExclusionCriteria |
| Details |
1. Subjects who develop post-operative complication or condition which requires hospitalization for >24 hours
2. Subjects chronically receiving systemic or topical steroidal or non-steroidal anti-inflammatory agents (including study drug Phlogam®/Disperzyme®), or analgesics, and immunosuppressive agents within respective 5 half-lives prior to administration of either Phlogam®/Disperzyme® or Serratiopeptidase in the study, except paracetamol and analgesics used as part of pre- and intra-operative medication
3. Subject is allergic, hypersensitive, or intolerant to investigational products or its excipients including lactose.
4. Subject is contraindicated to receive Phlogam®/ Disperzyme® or Serratiopeptidase as per the local prescribing information.
5. Subject has history of use of recreational drugs within 12 months prior to receiving the study drugs.
6. Sexually active women, unless surgically sterile or post-menopausal or willing to use an acceptable method of birth control for the duration of study.
7. Pregnant or lactating women.
8. Subject has received any investigational product or used any invasive investigational medical device within 30 days before the planned first dose |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To compare the proportion of subjects reporting none/mild swelling
2. To compare the proportion of subjects reporting no pain/mild pain
3. To compare the subject reported global assessment of change for pain and swelling
4. To compare the investigator reported global assessment of change for pain and swelling
5. To compare the number of subjects reporting any treatment emergent adverse event, any AE or SAE |
Day 3 post operative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the events in primary outcome on Day 8 Post Operative.
2. Number of rescue medications used in either groups. |
Day 8 of Post Operative |
|
|
Target Sample Size
|
Total Sample Size="303"
Sample Size from India="303"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="309" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/01/2018 |
| Date of Study Completion (India) |
30/05/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="6" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Systemic Enzyme Therapy With Trypsin-Bromelain-Rutoside Combination To Counter Post-Operative Wound Inflammation – A Randomized Active-Controlled Multicentre Trial. ejpmr, 2019,6(8), 493-500 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This was a multicentre, randomised, assessor blind, active controlled, phase IV study to assess the safety and efficacy of two treatment groups - Phlogam and Dispezyme ( Two different formulations of Bromelain, Trypsin and Rutoside), and compared the same against Serratiopeptidase in post-operative inflammation in subjects undergoing minor surgery and dental procedures. 1. Significantly more proportion of subjects reported with none/mild swelling or no/mild pain on Day 3 and Day 8 in treatment groups compared to Serratiopeptidase
2. Significantly more proportion of subjects reported vert good/excellent pain relief and swelling reduction on Day 3 and day 8 in treatment groups compared to Serratiopeptidase
3. 50% or more of maximum total pain relief over 8 hours from baseline was acheived with treatment groups
4. All 3 treatments were well tolerated and no significant safety concerns were noted. |