| CTRI Number |
CTRI/2017/11/010384 [Registered on: 06/11/2017] Trial Registered Prospectively |
| Last Modified On: |
31/08/2018 |
| 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 Efficacy of FDC of Trypsin 48 mg plus Bromelain 90 mg plus Rutoside Trihydrate 100 mg plus Diclofenac Sodium 50 mg enteric coated tablet versus Diclofenac Sodium 50 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 plus Diclofenac Sodium 50 mg enteric coated tablet versus Diclofenac Sodium 50 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-188-ENZO(F)-2015 Version 03 dated 06 Jul 2017 |
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
400093
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
400093
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, Andheri - (East)
Mumbai
Mumbai (Suburban)
MAHARASHTRA
400093
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 = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr K Durga Nagaraju |
Anu Hospital |
Dept of Orthopedics,Anu Hospitals,Kovelamudivari Street,Suryaraopet, Vijayawada–520002.
Krishna
ANDHRA PRADESH |
9885127788
drnagarajuk@gmail.com |
| Dr Sudhakar Sane |
Bhatia Hospital |
Dept of General Surgery, Bhatia Hospital Medical Research Society, Tardeo, Grant Road (W), Mumbai – 400007, Maharashtra, India.
Mumbai
MAHARASHTRA |
9820120363
crc.bhmrs@gmail.com |
| Dr Amit Kale |
Dr. D. Y. Patil Medical College, hospital & Research Center |
Department of Orthopedics, Dr.D.Y.Patil Medical College,hospital & Research Centre, Pimpri, Pune – 411018, Maharashtra, India
Pune
MAHARASHTRA |
9423585027
dramitkale@rediff.com |
| Dr Sanjeev Mohan |
KRM Hospital and Research Centre |
3/92-93, Vijayant Khand,Gomtinagar, Lucknow, Uttar Pradesh 226010, India
Lucknow
UTTAR PRADESH |
7007208089
0522-4079157
krmhrclko@gmail.com |
| Dr Vinit Yadav |
Popular Hospital |
N-10 / 60, A-2,D.L.W. Road, Near Flyover,Kakarmatta,Varanasi – 221004, Uttar Pradesh, India
Varanasi
UTTAR PRADESH |
9889776777
05422-300506
vinitdoctor@gmail.com |
| Dr Dasari Prasada Rao |
Rajiv Gandhi Institute of Medical Sciences & RIMS Government General Hospital |
Dept. of Surgery, Rajiv Gandhi Institute of Medical Sciences & RIMS Government General Hospital-532001, Andhra Pradesh, India.
Srikakulam
ANDHRA PRADESH |
9849702720
drprasadaraod@gmail.com |
| Dr Rajiv Daveshwar |
Sir Sayajirao General Hospital |
Jail Road (India Avenue) Vadodara- 390001, Gujarat India
Vadodara
GUJARAT |
9427322493
dr_rndaveshwar@yahoo.com |
| Dr Peeyush Chansouria |
Sudbhawana Hosptial |
B31/80,23B Bhogabir, Lanka,
Varanasi - 221005,
Uttar Pradesh, India
Varanasi
UTTAR PRADESH |
9336912471
0542-2367758
sudbhawanacrvns@gmail.com |
| Dr Hansraj Alva |
Vinaya Hospital And Research Centre |
P.O.No.717, Karangalpady, Mangaluru, 575003, Karnataka, India.
Dakshina Kannada
KARNATAKA |
9343562622
hansalva2001@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Ethics committee, Dr. D.Y. Patil Vidyapeeth |
Approved |
| ANU Hospital Ethics Committee |
Approved |
| Ethics Committee Vinaya Hospital |
Approved |
| Institutional Ethics Committee for Human Research Medical College & SSG Hospital |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE, BHATIA HOSPITAL MEDICAL RESEARCH SOCIETY |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE, RAJIV GANDHI INSTITUTE OF MEDICAL SCIENCES AND RIMS GOVERNMENT GENERAL HOSPITAL |
Approved |
| KRM Hospital Ethics Committee |
Approved |
| Popular Hospital Ethics Committee |
Approved |
| Sudbhawana Hospital 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 |
Fixed Dose Combination of Trypsin 48 mg plus Bromelain 90 mg plus Rutoside Trihydrate 100 mg plus Diclofenac Sodium 50 mg enteric coated tablet |
one tablet orally 2 times daily for 10 days before meal. |
| Comparator Agent |
Diclofenac Sodium 50 mg enteric coated tablet |
one tablet orally 2 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 |
| Number/percentage of patients with complete wound regeneration on day 5 and 10. |
Baseline,Day 5 and Day 10. |
| BATES-JENSEN WOUND ASSESSMENT TOOL (BWAT) score |
Baseline,Day 5 and Day 10. |
| 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)
|
07/11/2017 |
| 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 + Diclofenac Sodium 50 mg enteric coated tablet Versus Diclofenac Sodium 50 mg enteric coated tablet in patients for healing potential in surgical wounds after minor surgery. |