| CTRI Number |
CTRI/2018/04/013151 [Registered on: 10/04/2018] Trial Registered Prospectively |
| Last Modified On: |
16/01/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to evaluate the Safety and Effectiveness of Fixed Dose Combination of Trypsin 48 mg plus Bromelain 90 mg plus Rutoside Trihydrate 100 mg enteric coated tablet versus Serratiopeptidase 10 mg enteric coated tablet in patients with surgical wounds after minor surgery |
|
Scientific Title of Study
|
A Multicentric, Open label, Randomized, Comparative, Clinical Study evaluating Safety and Efficacy of Fixed Dose Combination of Trypsin 48 mg plus Bromelain 90 mg plus Rutoside Trihydrate 100 mg enteric coated tablet versus Serratiopeptidase 10 mg enteric coated tablet in patients for healing potential in surgical wounds after minor surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CT-189-ENZO(F)-2015 Version 04 Dated 12 Jan 2018 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashish Mungantiwar |
| Designation |
President -Medical Services |
| Affiliation |
Macleods Pharmaceuticals Ltd. |
| Address |
Macleods Pharmaceuticals Ltd.,
R&D, G-2, Mahakali Caves Road,
Shanti Nagar, Andheri East)
Mumbai
Mumbai (Suburban)
MAHARASHTRA
400 093
India |
| Phone |
02261132900 |
| Fax |
|
| Email |
drashish@macleodspharma.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashish Mungantiwar |
| Designation |
President -Medical Services |
| Affiliation |
Macleods Pharmaceuticals Ltd. |
| Address |
Macleods Pharmaceuticals Ltd.,
R&D, G-2, Mahakali Caves Road,
Shanti Nagar, Andheri East)
Mumbai
Mumbai (Suburban)
MAHARASHTRA
400 093
India |
| Phone |
02261132900 |
| Fax |
|
| Email |
drashish@macleodspharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Dinesh Garg |
| Designation |
Manager - Clinical Trials |
| Affiliation |
Macleods Pharmaceuticals Ltd. |
| Address |
Macleods Pharmaceuticals Ltd.,
R&D, G-2, Mahakali Caves Road,
Shanti Nagar, AndheriEast)
Mumbai
Mumbai (Suburban)
MAHARASHTRA
400 093
India |
| Phone |
02261132900 |
| Fax |
|
| Email |
dineshg@macleodspharma.com |
|
|
Source of Monetary or Material Support
|
| Macleods Pharmaceuticals Ltd, G-2, Mahakali Caves Road, Shanti Nagar, Andheri - (East),Mumbai – 400 093, India. |
|
|
Primary Sponsor
|
| Name |
Macleods Pharmaceuticals Ltd |
| Address |
G-2, Mahakali Caves Road, Shanti Nagar, Andheri - (East), Mumbai
– 400 093, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 14 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajesh Prajapati |
Ajanta Research Centre, Ajanta Hospital and IVF Centre |
No. 765, ABC Complex, Kanpur Road, Near Krishna Cinema, Alambagh, Lucknow-226005, Uttar Pradesh, India
Lucknow
UTTAR PRADESH |
9559782773
dr.rajeshkgmc@gmail.com |
| Dr Lata N Bhoir |
B.J.Govt. Medical college & Sassoon General Hospital, |
Surgery Department of Sassoon general Hospital and B. J. Government medical College, Near Pune Railway Station Pune, 411001 Maharashtra, India.
Pune
MAHARASHTRA |
9823664541
lbhoir03@gmail.com |
| Dr N K Chaudhry |
Christian Medical College and Hospital |
Department of Surgery, Christian Medical College and Hospital Ludhiana, 140018, Punjab, India
Ludhiana
PUNJAB |
9216030600
nkchaudhry@gmail.com |
| Dr Vasanth Kumar Reddy |
Krishna Institute of Medical Sciences (KIMS) |
#1-31/1, Minister Road,
Secunderabad- 500003,Telangana, India
Hyderabad
ANDHRA PRADESH |
09494945859
surgeon.vasanth@gmail.com |
| Dr Vishal Patil |
Lifepoint Multispeciality Hospital |
145/1, Mumbai Bangalore highway, Near Hotel Sayaji, Wakad, Pune-411023. Maharashtra, India.
Pune, Maharashtra
Pune
MAHARASHTRA |
9730475068
02066434399
pvlife200@gmail.com |
| Dr Vineet Kumar |
LTMMC & LTMGH |
Room no. 22, College Building 1st floor,
Dept of Surgery, LTMMC & LTMGH,
Sion, Mumbai 400 022
Mumbai
MAHARASHTRA |
9820231333
drvineetkumar@gmail.com |
| Dr Ajay Kumar Gupta |
Medipoint Hospital Pvt Ltd |
241/1,New D.P Road ,Aundh , Pune 411007,Maharashtra, India
Pune
MAHARASHTRA |
09922441226
ashray70@hotmail.com |
| Dr Mahendra Surywanshi |
MGM Medical College and Hospital |
MGM Medical College and Hospital, N-6, CIDCO, Aurangabad-431003 Maharashtra, India
Aurangabad
MAHARASHTRA |
8087401054
0240-2487727
drmahendrasurywanshi815@gmail.com |
| Dr Umesh Papurnia |
Noble Hospital Pvt Ltd. |
Department of Surgery, Magarpatta City road, Pune- 411013, Maharashtra, India
Pune
MAHARASHTRA |
9860172720
umeshpapurnia@gmail.com |
| Dr Pankaj Srivastava |
Om Surgical Center & Maternity Home |
SA 17/3, P-4, Sri Krishna Nagar colony, Paharia, Ghazipur Road,
Varanasi, Uttar Pradesh- 221 007, India
Varanasi
UTTAR PRADESH |
9125769989
05422588849
omresearchcenter@gmail.com |
| Dr Prashant Rahate |
Rahate Surgical Hospital |
517, Kolbaswami Square, Juni Mangalwari, Central Avenue, Nagpur– 440008, Maharashtra, India.
Nagpur
MAHARASHTRA |
9822464068
0712-2732266
prashantrahate84@yahoo.com |
| DrTSudheer |
Rajiv Gandhi Institute of Medical Sciences & RIMS Government General Hospital |
Assistant Prof. of Orthopaedics, Department of Orthopaedics, Rajiv Gandhi Institute of Medical Sciences & RIMS Government General Hospital, Srikakulam-532001,Andhra Pradesh India
Srikakulam
ANDHRA PRADESH |
9949900369
8942279033
drtsudheer@gmail.com |
| Dr Sandeep Agrawal |
Sir Ganga Ram Hospital |
Sir Ganga Ram Hospital Marg, Rajinder Nagar, New Delhi - 110060, India
New Delhi
DELHI |
09810779926
sagarwal3566@gmail.com |
| Dr Dhaval Mangukiya |
Surat Institute of Digestive Sciences |
Surat Institute of Digestive Sciences, Vijay Nagar, Besides Nirman Bhavan, Opp. Gandhi College, Majura Gate, Ring Road, Surat, Gujarat-395002, India.
Surat
GUJARAT |
9924083800
0261-2800170
drdhavalmangukiya@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 14 |
| Name of Committee |
Approval Status |
| Ethics Committe ,Ajanta hospital and IVF Center |
Approved |
| Ethics Committe,Sir ganga Ram Hospital. |
Approved |
| Ethics Committee of B.J.Govt. College & Sassoon general hospital, Pune |
Approved |
| Ethics Committee,Noble Hopital Pvt.Ltd. |
Approved |
| Institutional Committee Rahate Surgical Hospital |
Approved |
| Institutional ethics committee Christian Medical College and Hospital, Ludhiana |
Approved |
| Institutional Ethics Committee for Human Research LTMMC & LTMGH |
Approved |
| Institutional Ethics Committee Rajiv Gandhi institute of medical sciences and RIMS government general Hospital |
Approved |
| KIMS Ethics committee |
Approved |
| LPR Ethics Committee |
Approved |
| MGM Ethics Committee For Research on Human Subjects, Aurangabad |
Approved |
| Om Surgical Center & Maternity Home |
Approved |
| Penatmed Ethics Committee |
Approved |
| Surat Institute of Digestive Sciences Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients with surgical wounds after minor surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FDC of Trypsin 48 mg Plus Bromelain 90 mg Plus Rutoside Trihydrate 100 mg enteric coated tablet |
one tablet orally 3 times daily for 10 days before meal. |
| Comparator Agent |
Serratiopeptidase 10 mg enteric coated tablet |
one tablet orally 3 times daily for 10 days before meal. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Male or female patients who are 18 to 65 years of age with surgical wounds after minor surgery.
2.Patients able to follow all study directions and commit to come at all follow-up visits as per the protocol. In addition, subjects must be willing to accept the restrictions of the study.
3.Subjects have the willingness and ability to understand and provide written informed consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
1.Patients with Uncontrolled diabetes mellitus or any other metabolic disorder.
2.Patients with known hypersensitivity to any of the study related drugs.
3.Patient with hepatic and/or renal disorder, bleeding disorders, menorrhagia, hematuria and hematemesis.
4.Patients taking medicines such as tetracycline group of drugs, amoxicillin, aspirin, anticoagulants including clopidogrel should be excluded
5.Patients who are currently enrolled in another clinical investigation or have been enrolled in any surgical wound trial within a period of 30 days prior to enrollment in this study.
6.Women of child bearing age not using any contraceptive
7.Pregnant or nursing women
8.Any other condition that, in the opinion of the investigator, does not justify the inclusion of the subject in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate safety and tolerability in patients
with surgical wounds after minor surgery.
Incidence of adverse events and serious adverse
events.
Safety will be evaluated based on the adverse events reported and their plausible causal
relationship with the study drug.
2. Laboratory Investigations:
Hematology;Biochemistry. |
For 1: Day 5, 10.
For 2: Baseline, Day 10. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Number/percentage of patients with complete wound regeneration on day 5 and 10. |
Baseline, day 5, 10. |
| 2. BATES-JENSEN WOUND ASSESSMENT TOOL (BWAT) score |
Baseline, day 5, 10. |
| 3.Patient and investigator global efficacy impression |
Day 10 |
|
|
Target Sample Size
|
Total Sample Size="383"
Sample Size from India="383"
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)
|
16/04/2018 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Publication of the results of the study, whether in whole or in part, shall be within the sole and absolute discretion of Macleods Pharmaceuticals Ltd. and investigators shall not be entitled to publish any of the data or information arising during or out of the provision of the services without the prior written consent of Macleods Pharmaceuticals Ltd. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This Multicentric, Open
label, Randomized, Comparative, Clinical Study will evaluate Safety and
Efficacy of Fixed Dose Combination of Trypsin 48 mg + Bromelain 90 mg +
Rutoside Trihydrate 100 mg enteric coated tablet versus Serratiopeptidase 10
mg enteric coated tablet in patients for healing potential in surgical
wounds after minor surgery. |