| CTRI Number |
CTRI/2025/07/091138 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
06/04/2026 |
| 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 clinical study to evaluate the safety and efficacy of fixed dose combination of Aceclofenac Paracetamol and Serratiopeptidase Tablets. |
|
Scientific Title of Study
|
A Double-blind, Randomized, Multicentric, Comparative, Phase-IV Clinical Trial to Evaluate Safety, Efficacy and Tolerability of oral Tablets of FDC of Aceclofenac 100 mg, Paracetamol 325 mg and Serratiopeptidase 15 mg of Synokem Pharmaceuticals Limited in comparison with Aceclofenac 100mg and Paracetamol 325 mg in the treatment of Acute Painful Musculospastic Conditions. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CT23-005, Version No.: 01 and Date 28 Mar 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aditya Kaushik |
| Designation |
President - Drug Regulatory Affairs |
| Affiliation |
Synokem Pharmaceuticals Ltd. |
| Address |
Synokem Pharmaceuticals Ltd., 14/486, Sunder Vihar, Outer Ring Road, Paschim Vihar.
New Delhi
DELHI
110087
India |
| Phone |
9818637035 |
| Fax |
|
| Email |
aditya.kaushik@synokempharma.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aditya Kaushik |
| Designation |
President - Drug Regulatory Affairs |
| Affiliation |
Synokem Pharmaceuticals Ltd. |
| Address |
Synokem Pharmaceuticals Ltd., 14/486, Sunder Vihar, Outer Ring Road, Paschim Vihar.
DELHI
110087
India |
| Phone |
9818637035 |
| Fax |
|
| Email |
aditya.kaushik@synokempharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aditya Kaushik |
| Designation |
President - Drug Regulatory Affairs |
| Affiliation |
Synokem Pharmaceuticals Ltd. |
| Address |
Synokem Pharmaceuticals Ltd., 14/486, Sunder Vihar, Outer Ring Road, Paschim Vihar.
DELHI
110087
India |
| Phone |
9818637035 |
| Fax |
|
| Email |
aditya.kaushik@synokempharma.com |
|
|
Source of Monetary or Material Support
|
| Synokem Pharmaceuticals Ltd.,
Plot No. 35-36, Sector 6A, Integrated Industrial State (SIDCUL), Ranipur (BHEL), Haridwar-249403, 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 = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nakul Shivaramaiah |
Abhayahasta Multispeciality Hospital |
Research Room, Site No. 1-2, Katha No. 347/247, 2nd Cross, Kaggadasapura Main Road, CV Raman Nagar, Bengaluru (Bangalore)-560093.
Bangalore
KARNATAKA |
9611101801
cr@abhayahastahospital.com |
| Dr Tolani Kamal Lalchand |
Ashirwad Hospital and Research Centre |
Research Room, Maratha Section, Near Jijamata Udyan, Ulhasnagar,
Thane-421004.
Thane
MAHARASHTRA |
9890504805
drkltolani@yahoo.co.in |
| Dr Rakesh Verma |
Jawahar Lal Nehru Medical College |
Research Room, Kala Bagh, Ajmer-305001.
Ajmer
RAJASTHAN |
9460077585
rakeshverma.jln@outlook.com |
| Dr Vikalp Vashishitha |
Maharaja Agrasen Superspeciality Hospital |
Research Room, Central Spine, Agrasen Aspatal Marg, Sector 7, Vidyadhar Nagar,
Jaipur-302039.
Jaipur
RAJASTHAN |
9829113330
drvikalpvashishth@gmail.com |
| Dr Raja Bhattacharya |
Medical College and Hospital, Kolkata |
Department of Medicine, MCH Building, 2nd Floor, 88 College Street, Kolkata-700073.
Kolkata
WEST BENGAL |
8100273048
rbrbhattacharya@gmail.com |
| Dr Dhadiwal Rajesh Kantilal |
Swastik Dhadiwal Hospital |
Research Room, Trambak Road, Opp. Thakkar Bazzar, Matoshree Nagar, Nashik-422002.
Nashik
MAHARASHTRA |
0253-2578457
rkdhadiwal@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Ashirwad Ethics Committee, Ashirwad Hospital and Research Centre |
Approved |
| Institutional Ethics Committee for Human Research, Medical College and Hospital, Kolkata |
Approved |
| Institutional Ethics Committee, Abhayahasta Superspeciality Hospital, Abhayahasta Multispeciality Hospital |
Approved |
| Institutional Ethics Committee, Jawahar Lal Nehru Medical College |
Approved |
| Institutional Ethics Committee, Maharaja Agrasen Superspeciality Hospital |
Approved |
| Shree Institutional Ethics Committee, Dhadiwal Hospital In Coalition with Shreeji Health Care |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M628||Other specified disorders of muscle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
FDC of Aceclofenac 100 mg and Paracetamol 325 mg Tablets |
Patients will be advised to take the study medication orally, swallowed as a whole with water twice daily for 7 days. |
| Intervention |
FDC of Aceclofenac 100 mg, Paracetamol 325 mg and Serratiopeptidase 15 mg Tablets |
Patients will be advised to take the study medication orally, swallowed as a whole with water twice daily for 7 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female patients of 18 years and 60 years (both Inclusive),
2. Willing to provide 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.
4. Patients willing to comply with the protocol requirements |
|
| ExclusionCriteria |
| Details |
1. Patients known, or to be hypersensitivity to study drugs.
2. History of auto-immune 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 judgement of the study personnel. Make the subject inappropriate for inclusion.
5. Participation in other clinical trials the last three months and during study participation.
6. Patients 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. Patients with galactose or fructose intolerance.
8. Patients with severe renal impairment, including those receiving dialysis.
9. Patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities.
10. Patients with pre-existing gallbladder disease.
11. Active peptic ulcer disease.
12. Patients with chronic and degenerative conditions of pain.
13. Patients with the history of significant cardiovascular disorders, central nervous system disorders, endocrine disorder and other severe condition like asthma, uncontrolled hypertension and collagen disorders that may affect patient safety or difficult to evaluate the efficacy of the product.
14. Patients who have participated in any clinical trial in the past one month. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical global impression- Improvement (CGI-I) on a 7-point scale, pain intensity on a 11-point numerical rating scale (PI-NRS) will be measured from baseline to end of the study. |
Screening Visit (Visit 1),
Visit 2 / Day 1,
Visit 3 / Day 4 and
End of Study (Visit 4 / Day 7). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in the inflammatory markers (C-reactive protein) from baseline to end of the study. |
Screening Visit (Visit 1),
Visit 2 / Day 1,
Visit 3 / Day 4 and
End of Study (Visit 4 / Day 7). |
| Adverse events reported during the study. |
Throughout the study. |
| Serious adverse events reported during the study. |
Throughout the study. |
| Changes in clinical laboratory parameters from baseline to end of the study visit. |
Screening Visit (Visit 1) and
End of Study (Visit 4 / Day 7). |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
Final Enrollment numbers achieved (Total)= "250"
Final Enrollment numbers achieved (India)="250" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
04/08/2025 |
| Date of Study Completion (India) |
06/03/2026 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
All eligible patients clinically manifesting with symptoms of acute painful
musculospastic conditions would be informed about the nature of the study and
consent would be taken. After informed consent is obtained, patients will be
screened with respect to laboratory tests and inclusion/exclusion criteria will
be randomized on Day 1. Patients that are determined eligible based upon the
screening and inclusion criteria will enter the 7 days treatment period. Approximately
250 patients will be randomized in the study. Patients will be randomized at
each center to receive one of the two strengths of either the study drug
(Aceclofenac 100 mg, Paracetamol 325 mg and Serratiopeptidase 15 mg Tablets) or
the comparator drug starting from the day of randomization to Day 7. Patients
will be given tablets of either the study drug or the comparator as per their
random allocation, for a period of 4 days during the first visit and for another
3 days after first follow up on Day 4. Patients will be provided with drug
sufficient for 7-day treatment duration in a strip packs. Patients will be
called on as per the flow chart of the trial after receiving active drug
treatment for follow-up. At the time of follow-up, they will be judged on the
basis of interrogation and clinical global impression- Improvement (CGI-I) on a
7-point scale, pain intensity on a 11-point numerical rating scale (PI-NRS) and
Treatment compliance will be judged by the return of empty strips and crosschecked
with diary. Clinical Global Impression of Improvement (CGI-I) will be
administered at the completion visit. Throughout
the trial period, the patients will be in continuous communication for
recording the adverse event/serious adverse event or adverse reactions. Laboratory
investigations should be conducted at first and last visit. In every visit
patient will be evaluated for general, systemic and physical examination, vital
signs, concomitant medication and AE / SAE Recording. The total duration of the
study will be at least 7 days for Acute Painful Musculospastic Conditions. |