| CTRI Number |
CTRI/2023/09/057919 [Registered on: 21/09/2023] Trial Registered Prospectively |
| Last Modified On: |
05/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Ligashot in
Ligament injury |
|
Scientific Title of Study
|
Evaluate the efficacy and safety of Ligashot in
Ligament injury (Knee sprain, Ankle sprain, Shoulder dislocation,
Post-operative recovery) patients of Grade 1 and 2. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LIGASHOT/13/23 version 1.0 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M Sakthi Balan |
| Designation |
Consultant Diabetologist and CI |
| Affiliation |
Thirumalai medical Centre, ki3 |
| Address |
Thirumalai Medical Centre, Room No 1,Thirumalai Medical Centre, No 408, Cuddalore Road Nainarmanadapam, Puducherry
Pondicherry
PONDICHERRY
605004
India |
| Phone |
9443627722 |
| Fax |
|
| Email |
saheerose@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Sakthi Balan |
| Designation |
Consultant Diabetologist and CI |
| Affiliation |
Thirumalai medical Centre, ki3 |
| Address |
Thirumalai Medical Centre, Room No 1,Thirumalai Medical Centre, No 408, Cuddalore Road Nainarmanadapam, Puducherry
PONDICHERRY
605004
India |
| Phone |
9443627722 |
| Fax |
|
| Email |
saheerose@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayathri Sivakumar |
| Designation |
CEO |
| Affiliation |
KI3, CRO |
| Address |
KI3,Room No: 1, KI3 Office, Regus Centre Level 2 Altius Block, No 1 SIDCO Industrial Estate, Chennai- 600044
Chennai
TAMIL NADU
600044
India |
| Phone |
9003109416 |
| Fax |
|
| Email |
drgayathri@ki3services.com |
|
|
Source of Monetary or Material Support
|
| Innovcare LifeSciences Pvt Ltd, Vani Apartment Vikas Centre, 8th Floor, Wadavli, Vasant Vihar Complex, Chembur, Mumbai, Maharashtra 400074 |
|
|
Primary Sponsor
|
| Name |
Innovcare LifeSciences Pvt Ltd |
| Address |
802, Vani Apartment Vikas Centre, E, Choithram Gidwani Rd, Wadavli, Vasant Vihar Complex, Chembur, Mumbai, Maharashtra 400074 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr M Sakthi Balan |
Thirumalai Medical Centre |
Room no.1, General Medicine OP, Thirumalai Medical Centre, No 408 Cuddalore Road Nainarmandapan Puducherry Pondicherry PONDICHERRY
Pondicherry
Chennai
TAMIL NADU |
9443627722
saheerose@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHIQUE DE LA NATURE ASSOCIATION |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ligashot (Aflapin 100 mg
Collagen Peptide 150 mg
Glucosamine Sulphate 250 mg
Chondroitin 200 mg) |
taken orally once daily at night for 3 months |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female patients aged more than 18 years with grade 1 and 2 Ligament injury of knee,
ankle or shoulder – with or without dislocation.
2. Pain defined by a level of greater than or equal to 30 mm on a 100 mm Visual Analogue Scale
(VAS)
3. Patient should have not participated in any other clinical trial during the past 3 months.
4. Participants, who are willing to give written, signed and dated informed consent to participate in
the study. |
|
| ExclusionCriteria |
| Details |
1. Prior knee ligament surgery of the involved knee;
2. Torn or avulsed patellar or quadriceps tendon;
3. Periarticular or long bone fracture that is anticipated to preclude weight-bearing after
surgery;
4. Require use of an external fixator for greater than 10 days;
5. Planned staged surgical treatment;
6. Unable to weight bear on the contralateral uninjured leg;
7. Traumatic brain injury (TBI) that limits their ability to participate in their post-operative
care;
8. Surgical procedures that precludes early weight-bearing or range of motion.
9. Any condition that would preclude the ability to comply with post-operative guidelines
10. Moderate to severe renal impairment
11. Pregnant or lactating
12. History of hypersensitivity to any of the test products.
13. Any condition decided as unfit for study by clinical investigator |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change from baseline to 16 weeks in pain intensity measured by Pain VAS Scale.
2. Time to return to pre-injury level of activity.
3. Multiple Ligament
Quality of Life (MLQoL) Questionnaire.
4. Change in ESR and CRP
5. Global rating change
6. MRI assessment
|
Day 0 and week 12
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To demonstrate safety and tolerability of study product by Clinical AEs,
including laboratory abnormalities (If any)
Safety and tolerability evaluation criteria:
Adverse events and serious adverse events during the study period |
Day 0, Week 4, Week 8 , Week 12 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/09/2023 |
| Date of Study Completion (India) |
01/02/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
The Subjects who fulfilled the inclusion and exclusion criteria will be enrolled in the study. 30 Participants will be randomized into single group. Dosing will be done twice daily orally for 12 weeks. Subjects will be asked to visit clinical facility/ institution for their follow up at the end of week 4, week 8 and week 12 and any other additional visits if needed
Primary and Secondary Outcome
1) VAS Scale 2) Time to return to Pre-Injury level of activity 3) Patient Reported Physical Function- Activity Limitation Scale of Multiple Ligament Quality of Life (MLQoL) Questionnaire 4) Hs-C Reactive Protein 5) ESR 6) Global Rating of Change 7) Activity Limitation Scale of Multiple Ligament 8) MRI Scan
|