| CTRI Number |
CTRI/2025/08/092605 [Registered on: 07/08/2025] Trial Registered Prospectively |
| Last Modified On: |
24/12/2025 |
| Post Graduate Thesis |
|
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Evaluate the Safety and Effect of ACECLO SERA Tablet in the treatment of acute painful Muscle and bone conditions. |
|
Scientific Title of Study
|
A Double blind Randomized Multicentric Comparative Phase IV Clinical Trial to Evaluate the Safety Tolerability and Efficacy of oral Tablets of ACECLO SERA Fixed dose combination of Aceclofenac 100 mg plus Paracetamol 325 mg plus Serratiopeptidase 15 mg in comparison with Aceclofenac 100 mg plus Paracetamol 325 mg in the treatment of acute painful musculospastic conditions. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AZ-C-ZIR-19-102 version 03, 30/05/2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manish Maladkar |
| Designation |
Senior President Medical and Regulatory affairs |
| Affiliation |
Aristo Pharmaceuticals Private Limited |
| Address |
Aristo Pharmaceuticals Private Limited
23 A Shah Industrial Estate off Veera Desai road Andheri west
Mumbai (Suburban)
MAHARASHTRA
400053
India |
| Phone |
2268309999 |
| Fax |
|
| Email |
scientific@aristopharma.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shrikant Patil |
| Designation |
Senior DGM Medical |
| Affiliation |
ARISTO Pharmaceuticals Private Limited |
| Address |
Aristo Pharmaceuticals Private Limited
23 A Shah Industrial Estate off Veera Desai road Andheri west
Mumbai (Suburban)
MAHARASHTRA
400053
India |
| Phone |
2268309999 |
| Fax |
|
| Email |
aepvc.scientific@aristopharma.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahendra Chaudhari |
| Designation |
HOD Clinical Research |
| Affiliation |
Anazeal Analyticals and Research Private Limited |
| Address |
Anazeal Analyticals and Research Private Limited
C 404 TTC Industrial area opp JISL MIDC Pawane Navi Mumbai
Thane
MAHARASHTRA
400705
India |
| Phone |
02227633040 |
| Fax |
|
| Email |
ct1@anazeal.com |
|
|
Source of Monetary or Material Support
|
| Aristo Pharmaceuticals Private Limited. 23 A shah Industrial estate off veera desai road Andheri west Mumbai 400053 Maharashtra India. |
|
|
Primary Sponsor
|
| Name |
Aristo Pharmaceuticals Private Limited |
| Address |
23 A Shah Industrial Estate off Veera Desai road Andheri west Mumbai 400053 Maharashtra 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 Vivek Sharma |
Chandra Laxmi Hospital |
Chandra Laxmi Hospital, Sector 4, Vaishali, Ghaziabad, Uttar Pradesh 201019
Ghaziabad
UTTAR PRADESH |
9811146858
viveksharmact@gmail.com |
| Dr Ch V Murali Krishna |
Government Medical college and Govt General Hospital |
Department of Medicine Government Medical college and Govt General Hospital Srikakulam
Srikakulam
ANDHRA PRADESH |
9912320517
muralidhargudla@yahoo.com |
| Dr K Sunil Naik |
Government Medical college and Govt General Hospital |
Department of Medicine Government Medical college and Govt General Hospital Srikakulam
Srikakulam
ANDHRA PRADESH |
9912320517
drsunilnaikggh@gmail.com |
| Dr Sagar Redkar |
Redkar Hospital and research center, Goa |
Redkar Hospital and Research Center, Mumbai Goa Highway, Oshalbag, Dhargal, Pernem, Goa 403513 India
North Goa
GOA |
7969792769
redkardr.sagar@gmail.com |
| Dr Vilas Musale |
Renukai Critical Care and Multispeciality Hospital, Nanded |
Renukai Critical Care and Multispeciality Hospital, Behind LIC Office, Bafna Road, Nanded 431602
Nanded
MAHARASHTRA |
9766723204
drvilas.research@gmail.com |
| Dr Ajit Kumar Kar |
Shanti Memorial Hospital |
Shanti Memorial Hospital, Thoria Sahi, Patnaik Colony, Magalbag, Cuttack, Odisha
Bhubaneswar
Cuttack
ORISSA |
09912320517
ajittapu12@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE SHANTI HOSPITAL |
Approved |
| IEC Redkar Hospital and Research Centre |
Approved |
| Institutional Ethics Committee Govt. Medical College Govt. General Hospital Balaga |
Submittted/Under Review |
| Institutional Ethics Committee Govt. Medical College Govt. General Hospital Balaga Srikakulam |
Approved |
| Renukai Institutional Ethics Committee |
Approved |
| Waves Women Empowerment |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Aceclo Plus |
Fixed dose combination tablet of Paracetamol 325 mg plus Aceclofenac 100 mg
Treatment- 7 Days |
| Intervention |
Aceclo SERA |
Fixed dose combination tablet of Aceclofenac 100 mg plus Paracetamol 325 mg plus Serratiopeptidase 15 mg
Treatment- 7 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either gender between 18 and 60 years of age (inclusive of both).
2. Patients suffering from acute pain with spasm such as prolapsed intervertebral disc, sprains and dislocations, spondylosis ( Lumbar, cervical, ankylosing spondylosis), spinal stenosis, periarthritis, frozen shoulder, prepatellar bursitis, spondylolisthesis, low back pain, tendonitis, tenosynovitis, bursitis.
3. Patients are willing to provide written informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Patients with known 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 judgment 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 of 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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of ACECLO-SERA (Fixed dose combination tablet of Aceclofenac 100 mg plus Paracetamol 325 mg plus Serratiopeptidase 15 mg tablet versus ACECLO PLUS Fixed dose combination tablet of Aceclofenac 100 mg plus Paracetamol 325 mg in the treatment of acute painful musculospastic conditions. |
Visit 1 Day 0 Screening and enrollment.
Visit 2 Day 4 follow up visit.
Visit 3 Day 7 End of study
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the safety & tolerability of ACECLO-SERA (Fixed dose combination tablet of Aceclofenac 100mg plus Paracetamol 325mg plus Serratiopeptidase 15mg tablet versus ACECLO PLUS Fixed dose combination tablet of Paracetamol 325 mg plus Aceclofenac 100 mg in the treatment of acute painful musculospastic conditions. |
Visit 1 Day 0 Screening and enrollment.
Visit 2 Day 4 follow up visit.
Visit 3 Day 7 End of study |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
25/08/2025 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Study Title: A Double blind Randomized Multicentric Comparative
Phase IV Clinical Trial to Evaluate the Safety Tolerability and Efficacy of
oral Tablets of ACECLO SERA Fixed dose combination of Aceclofenac 100 mg plus
Paracetamol 325 mg plus Serratiopeptidase 15 mg in comparison with Aceclofenac
100 mg plus Paracetamol 325 mg in the treatment of acute painful musculospastic
conditions. Test Product: Aceclo
SERA Fixed-dose combination tablet of
Aceclofenac 100 mg plus Paracetamol 325 mg plus Serratiopeptidase 15 mg. Reference Product:
Aceclo Plus Fixed dose combination
tablet of Paracetamol 325mg plus Aceclofenac 100 mg. Primary Objective: To compare the efficacy of
ACECLO SERA (Fixed dose combination tablet of Aceclofenac 100 mg plus
Paracetamol 325 mg plus Serratiopeptidase 15 mg tablet versus ACECLO PLUS Fixed
dose combination tablet of Aceclofenac 100 mg plus Paracetamol 325 mg in the
treatment of acute painful musculospastic conditions. Secondary Objective: To compare the safety
& tolerability of ACECLO SERA (Fixed dose combination tablet of Aceclofenac
100mg plus Paracetamol 325mg plus Serratiopeptidase 15mg tablet versus ACECLO
PLUS Fixed dose combination tablet of Paracetamol 325 mg plus Aceclofenac 100
mg in the treatment of acute painful musculospastic conditions. Treatment
Duration 7 days Study Endpoints Efficacy: - Mean
change in pain intensity numerical rating scale (PI NRS) from baseline to day
7.
- Clinical Global Impression of improvement (CGI-I) a
7 point scale will be used for assessment of improvement in pain.
Safety and
Tolerability: - Any
adverse event reported voluntarily, observed or enquired during the study
period.
- Any clinically significant change in the value of
laboratory tests, vital signs and physical examination findings during the
study compared to baseline.
- Global
assessment of safety & tolerability by Investigator and Patient.
|