| CTRI Number |
CTRI/2024/05/067356 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
14/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Trial for evaluating the safety and efficacy of a FDC combination in treatment of painful musculospastic condition |
|
Scientific Title of Study
|
A Double-blind, Randomized, Multicentric, Comparative, Phase IV clinical trial to evaluate efficacy, safety & Tolerability of oral tablets of fixed dose combination of Aceclofenac 100 mg + Paracetamol 325 mg + Serratiopeptidase 15 mg in comparison with Aceclofenac 100 mg + Paracetamol 325 mg tablets in the treatment of acute painful musculospastic conditions. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CT-CE-AD-2023 Version 2.0 dated 17-oct-2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashwini Kumar |
| Designation |
CEO |
| Affiliation |
CliniExperts Research Services Pvt Ltd |
| Address |
Unit No. 324-325, City Centre Mall, Plot No. 5, Pocket 8, Block B, Sector 12 Dwarka, Dwarka
West
DELHI
110075
India |
| Phone |
9999219448 |
| Fax |
|
| Email |
ashwini.kumar@cliniexpertsresearch.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Veena Venkatesh |
| Designation |
Deputy General Manager |
| Affiliation |
Albert David Limited |
| Address |
B- 402, 4th floor. Ackruti Trade centre, MIDC, Andheri (E)
Mumbai
MAHARASHTRA
400093
India |
| Phone |
02249240463 |
| Fax |
|
| Email |
veena.venkatesh@adlindia.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Veena Venkatesh |
| Designation |
Deputy General Manager |
| Affiliation |
Albert David Limited |
| Address |
B- 402, 4th floor. Ackruti Trade centre, MIDC, Andheri (E)
MAHARASHTRA
400093
India |
| Phone |
02249240463 |
| Fax |
|
| Email |
veena.venkatesh@adlindia.in |
|
|
Source of Monetary or Material Support
|
| Albert David Limited, 5/11, D. Gupta Lane, Kolkata-700050 |
|
|
Primary Sponsor
|
| Name |
Albert David Limited |
| Address |
5/11, D. Gupta Lane, Kolkata-700050 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prateek Lodha |
Aatman Hospital |
5, Anveshan Row House, opp. Umiya Mata Mandir, Bopal-Ghuma, Main Road, Bopal
Ahmadabad
GUJARAT |
7574814462
drprateek239@gmail.com |
| Dr Saravanan R |
Harshamitra Super Specialty Cancer Centre and Research Institute |
101/4A, Mathur Panchayat Road, Trichy-Madurai Highway, Nagamangalam, Trichy-620012
Tiruchirappalli
TAMIL NADU |
9578190979
Saravanan867@gmail.com |
| Dr Gyaneshwar Tank |
LLRM Medical College |
Orthopedic Dept. LLRM Medical College, Meerut, Uttar Pradesh-250004, India
Meerut
UTTAR PRADESH |
9897600445
gyaneshwartonk@gmail.com |
| Dr Badal Kumar Sahu |
NRS Medical College and Hospital |
Department of General Medicine.
NRS Medical College and Hospital.
138, Acharya Jagdish Chandra Bose Rd, Sealdah, Raja Bazar, Kolkata, West Bengal 700014.
Kolkata
WEST BENGAL |
8240184543
drbksahu75@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Ethics Committee NRS Medical College |
Submittted/Under Review |
| Institutional Ethics Committee Aatman Hospital |
Approved |
| Institutional Ethics Committee Harshamitra Superspeciality Cancer Centre |
Submittted/Under Review |
| Institutional Ethics Committee LLRM Medical College |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M150||Primary generalized (osteo)arthritis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
FDC of Aceclofenac (100 mg) + Paracetamol (325 mg) |
Aceclofenac (100 mg) + Paracetamol (325 mg)
Dose: Aceclofenac (100 mg) + Paracetamol (325 mg)
Frequency: 1 tablet twice a day
Route of Administration: Oral
Duration: 7 days |
| Intervention |
FDC of Aceclofenac (100 mg) + Paracetamol (325 mg) + Serratiopeptidase (15 mg) |
Aceclofenac (100 mg) + Paracetamol (325 mg) + Serratiopeptidase (15 mg)
Dose: Aceclofenac (100 mg) + Paracetamol (325 mg) + Serratiopeptidase (15 mg)
Frequency: 1 tablet twice a day
Route of Administration: Oral
Duration: 7 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female aged more than 18 years and less than 60 years (both inclusive)
2. Willing to give written informed consent
3. Subjects suffering from acute painful conditions with spasm such as prolapsed intervertebral disc, sprains and dislocations, spondylosis (Lumbar, Cervical, ankylosing spondylosis), spinal stenosis, periarthritis, frozen shoulder, prepatellar bursitis, spondylolisthesis, low backpain, tendonitis, tenosynovitis, bursitis. |
|
| ExclusionCriteria |
| Details |
1.Subjects with known hypersensitivity to any of the study drugs.
2.History of autoimmune disease.
3.Concurrent use of corticosteroids.
4.Any medication or indication that might point to an increased risk. Associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the study personnel. Make the subject inappropriate for the inclusion.
5.Participation in another clinical trial in the last three months and during study participation
6.Subjects with history of epilepsy, or those at-risk seizures or taking seizure drugs in pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control
7.Subjects with Galactose or fructose intolerance.
8.Subjects with severe renal impairment, including those receiving dialysis
9.Subjects with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities.
10.Subjects with pre-existing gallbladder disease.
11.Active peptic ulcer disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Pain reduction on day 7 of treatment by assessing pain intensity using the PI NRS scale, compared to baseline PI NRS scale.
2.Change or Improvement in the CGI scale from baseline to the end of the treatment. |
Day 1, Day 3, Day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Incidence of adverse events (AEs) and serious adverse events (SAEs).
2.Pain relief with study medication on days 1, 3 and day 7 by using PI NRS scale.
|
Day 1, Day 3, Day 7 |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
27/05/2024 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aceclofenac + Paracetamol + Serratiopeptidase is a combination of three medicines: Aceclofenac, Paracetamol and Serratiopeptidase. Aceclofenac is a non-steroidal anti-inflammatory drug (NSAID), and Paracetamol is an antipyretic (fever reducer). They work by blocking the release of inflammatory mediator prostaglandin that cause pain and fever. Serratiopeptidase is an enzyme which works by reduces capillary permeability induced by histamine, bradykinin, and serotonin; breaks down abnormal exudates and proteins; facilitates the absorption of decomposed products through blood and lymphatics at the site of inflammation and promotes healing. The rationale of study is to evaluate efficacy and safety & Tolerability of oral tablets of fixed dose combination of Aceclofenac (100 mg) + Paracetamol (325 mg) + Serratiopeptidase (15 mg) in comparison with Fixed dose combination of Aceclofenac (100 mg) + Paracetamol (325 mg) in the treatment of acute painful musculospastic conditions. |