| CTRI Number |
CTRI/2021/10/037277 [Registered on: 12/10/2021] Trial Registered Prospectively |
| Last Modified On: |
05/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to evaluate the safety and efficacy of Fixed Dose Combination of Trypsin-Chymotrypsin, Bromelain and Rutoside Trihydrate Tablets. |
|
Scientific Title of Study
|
“An Open Label, Prospective, Non-comparative, Multicentre, Phase IV Clinical Study to Evaluate the Safety, Tolerability and Efficacy of FDC of Trypsin - Chymotrypsin 50000 AU plus Bromelain 90 mg plus Rutoside Trihydrate 100 mg Tablets in Subjects for the treatment of conditions associated with Inflammation and edema of traumatic origin.†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CRPL/CT/19/009 |
Protocol Number |
| Version No. 00 & Dated Apr 22, 2019 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr A Gopal Rao |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College & Government General Hospital (Old RIMSGGH) |
| Address |
Department of Medicine,
Government Medical College & Government General Hospital (Old RIMSGGH), Srikakulam.
Srikakulam
ANDHRA PRADESH
532001
India |
| Phone |
8942279033 |
| Fax |
|
| Email |
drgopalraoa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajasekhara Reddy Tamma |
| Designation |
Managing Director |
| Affiliation |
Clinwave Research Pvt. Ltd. |
| Address |
Clinwave Research Pvt. Ltd.,
# H. No.: 4-32-41/13, Plot No.: 38,
Kamala Prasanna Nagar,
Near Ramalayam Temple,
Kukatpally, Hyderabad.
Hyderabad
TELANGANA
500072
India |
| Phone |
7989233379 |
| Fax |
|
| Email |
dr.sekhar@clinwave.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr Surender Kumar Arora |
| Designation |
President - Drug Regulatory Affairs |
| Affiliation |
Synokem Pharmaceuticals Ltd. |
| Address |
Synokem Pharmaceuticals Ltd., 14/486, Sunder Vihar, Outer Ring
Road, Paschim Vihar, New Delhi.
New Delhi
DELHI
110087
India |
| Phone |
9811015684 |
| Fax |
|
| Email |
ska@synokempharma.com |
|
|
Source of Monetary or Material Support
|
| Synokem Pharmaceuticals Ltd.,
14/486, Sunder Vihar,
Outer Ring Road, Paschim Vihar,
New Delhi-110087, India. |
|
|
Primary Sponsor
|
| Name |
Synokem Pharmaceuticals Ltd |
| Address |
14/486, Sunder Vihar,
Outer Ring Road, Paschim Vihar, New Delhi-110087, India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr K Durga Nagarju |
Anu Hospitals |
Research Room, Kovelamudivari Street, Suryaraopet, Vijayawada-520002.
Krishna
ANDHRA PRADESH |
7893062708
anuhospitalscr@gmail.com |
| Dr Vijai Kumar |
Charak Hospital and Research Centre |
Research Room, Hardoi Road, Dubagga, Lucknow-226003.
Lucknow
UTTAR PRADESH |
9415011840
drvijaykumar96@gmail.com |
| Dr Pranab Kumar Chowdhury |
Down Town Hospital |
Research Room, Dispur, G.S. Road, Guwahati-781006.
Kamrup
ASSAM |
8486664152
pranabioc2002@gmail.com |
| Dr D Anil Kumar |
Gandhi Medical College and Hospital |
Department of General Medicine, In Patient Block, 3rd Floor, Musheerabad, Secunderabad-500003.
Hyderabad
TELANGANA |
9440523902
anilddrmd@gmail.com |
| Dr A Gopal Rao |
Government Medical College & Government General Hospital (Old RIMSGGH) |
Department of Medicine, Srikakulam-532001.
Srikakulam
ANDHRA PRADESH |
8942279033
drgopalraoa@gmail.com |
| Dr Anil Kumar Gupta |
GSVM Medical College |
Department of Orthopedics, Swaroop Nagar, Kanpur-208002.
Kanpur Nagar
UTTAR PRADESH |
9839345016
guptadrakg@rediffmail.com |
| Dr Vikalp Vashishitha |
Maharaja Agrasen Superspeciality Hospital |
Research Room, Central Spine, Agrasen Aspatal Marg, Sector-7, Vidyadhar Nagar, Jaipur-302039.
Jaipur
RAJASTHAN |
9829113330
vikalpvashishtha@gmail.com |
| Dr P Anand Yadav |
Osmania Medical College and General Hospital |
Department of Clinical Research, Osmania General Hospital, Afzalgunj, Hyderabad-500012.
Hyderabad
TELANGANA |
9159860037
anand6pasula@gmail.com |
| Dr Dattaraj K Nasnolkar |
Redkar Hospital and Research Centre |
Department of Clinical Research,
Mumbai-Goa Highway, Oshalbag, Village-Dhargal,
Tal-Pernem, Goa-403513.
North Goa
GOA |
9158592177
redkar.research@gmail.com |
| Dr Mohan Kumar Singh |
W Pratiksha Hospital |
Research Room, Golf Course Ext. Road, Sushant Lok II, Sector 56, Gurugram-122011.
Gurgaon
HARYANA |
9910431665
drmksingh2012@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Ethics Committee, Down Town Hospital |
Approved |
| Ethics Committee, GSVM Medical College |
Approved |
| Institutional Ethics Committee, Anu Hospitals |
Approved |
| Institutional Ethics Committee, Charak Hospital & Research Centre |
Approved |
| Institutional Ethics Committee, Gandhi Medical College / Hospital |
Submittted/Under Review |
| Institutional Ethics Committee, Government Medical College & Government General Hospital (Old RIMSGGH) |
Approved |
| Institutional Ethics Committee, Maharaja Agrasen Superspeciality Hospital |
Approved |
| Institutional Ethics Committee, Osmania Medical College and General Hospital |
Submittted/Under Review |
| North East Healthcare Private Limited, W Pratiksha Hospital |
Approved |
| Redkar Hospital Institutional Ethics Committee (RHIEC), Redkar Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S934||Sprain of ankle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FDC of Trypsin – Chymotrypsin 50000 AU plus Bromelain 90 mg plus Rutoside Trihydrate 100 mg Tablets |
Patients will be advised to take the study medication orally, swallowed as a whole with water twice daily for 7 days. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female patients aged between 18 to 65 (both inclusive) years.
2. Patients with conditions associated with Inflammation and edema of traumatic origin such as Ankle sprain or Sport injuries or Tendinitis or Post-surgery of tooth extraction.
3. Patients with pain at baseline must be ≥ 30 mm on a 0- 100 mm Visual Analogue Scale.
4. Patient with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
5. Patients willing to comply with the protocol requirements. |
|
| ExclusionCriteria |
| Details |
1. Patients with known history of intolerance, hypersensitivity or any other contraindication to study drug.
2. Patients with clinical laboratory evaluations (including clinical chemistry, hematology and complete urinalysis) are not within the reference range for the testing laboratory and the results are deemed clinically significant by the investigator.
3. Patients treated with other analgesic (NSAIDS, Opioids and Corticosteroids) medications within 1 week prior to the study.
4. Patients with chronic and degenerative conditions of pain.
5. Pregnant or lactating women.
6. Female patients who are of childbearing potential and who are neither surgically sterilized nor willing to use reliable contraceptive methods (like hormonal, barrier methods or intrauterine device).
7. Patients with the history of significant cardiovascular disorders, central nervous system disorders, endocrine disorder, hepatic impairment, renal impairment and other severe condition like asthma, uncontrolled hypertension, collagen disorders, severe infection etc. or any other medical illness that may affect patient safety or difficult to evaluate the efficacy of the product.
8. Patients with clinically significant impaired renal or hepatic function (SGOT and SGPT more than 2.5X the UNL).
9. Patients with estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m2.
10. Patients with known case of Type 1 Diabetes and Type 2 Diabetes Mellitus whose diabetes has not been stable and uncontrolled for the previous three months and with HbA1c value greater than 8%.
11. Patients with a history of actively bleeding peptic ulceration or gastrointestinal bleeding. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients reporting incidences of AE and/or SAE during the study and their assessment in respect to intensity, duration, pattern and causal relationship to the study medication. |
Throughout the Study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Visual Analog Scale (VAS) from baseline to end of the study. |
At Baseline, Day 3 and Day 7 |
| Improvement in Subjects Global Assessment (SGA) and Physicians Global Assessment (PGA) at the end of the study. |
At Day 7 |
| Changes in Laboratory Safety Parameters (Hematology, Serum Biochemistry and Urine analysis) from baseline to end of the study. |
At Baseline and Day 7 |
| Changes in Vital Signs from baseline to end of the study. |
At Baseline, Day 3 and Day 7 |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "201"
Final Enrollment numbers achieved (India)="201" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/11/2021 |
| Date of Study Completion (India) |
11/12/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This
trial is an open label, prospective,
non-comparative, multicentre, phase IV clinical study to evaluate the safety, tolerability
and efficacy of FDC of Trypsin - Chymotrypsin 50000 AU + Bromelain 90 mg +
Rutoside Trihydrate 100 mg Tablets in subjects for the treatment of conditions
associated with inflammation and edema of traumatic origin.
Subjects
who are willing and able to participate in the study will sign and date the informed
consent form on the day of screening / baseline visit (Visit 1). During this
screening period, subjects who are willing to give consent will be evaluated
for all the eligibility criteria. Eligible subjects with conditions associated
with inflammation and edema of traumatic origin such as ankle sprain or sport
injuries or tendinitis or post-surgery of tooth extraction and who are aged 18
to 65 years of age (both inclusive) will be considered for the study.
After confirming the inclusion/exclusion criteria the
subject will be enrolled and provided with study medication at enrollment
visit. Subjects will be provided with patient diary at enrollment visit, which
need to be brought along with in each subsequent visit till the last visit.
Follow up visits will be done on day 3 and day 7±1 (Final Visit) of treatment
to assess safety, tolerability and efficacy. |