| CTRI Number |
CTRI/2024/03/064567 [Registered on: 20/03/2024] Trial Registered Prospectively |
| Last Modified On: |
26/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect OF TENDOSHOT PRO In Tendon Injury |
|
Scientific Title of Study
|
A case study to evaluate the efficacy and safety of Tendoshot
Pro in Tendon Injury (Knee Sprain, Ankle Sprain (Achilles
Heel), Shoulder Dislocation, Post-Operative Recovery, Plantar
fasciitis) Patients of Grade 2 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TENDOSHOT /03/24 Ver 1.1 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sakthi Balan |
| Designation |
Consultant, Physician |
| Affiliation |
Ki3 Private Limited |
| Address |
Room 2, 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 Sakthi Balan |
| Designation |
Consultant, Physician |
| Affiliation |
Ki3 Private Limited |
| Address |
Room 2, Thirumalai Medical Centre, No 408, Cuddalore Road Nainarmanadapam, Puducherry
Pondicherry
PONDICHERRY
605004
India |
| Phone |
9443627722 |
| Fax |
|
| Email |
saheerose@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayathri Sivakumar |
| Designation |
Director |
| Affiliation |
Ki3 Private Limited |
| Address |
Room No 1,Ki3 Private Limited, 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 Private Limited, India. |
|
|
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 Sakthi Balan |
Thirumalai Medical Centre |
Thirumalai Medical Centre, Room No 1,Thirumalai Medical Centre, No 408, Cuddalore Road Nainarmanadapam, Puducherry
Pondicherry
PONDICHERRY |
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: S869||Injury of unspecified muscle and tendon at lower leg level, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Tendoshot Pro |
1 tablet twice daily orally after food for 12 weeks |
|
|
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 Tendon 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/ankle /shoulder surgery;
2. Torn or avulsed 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. Any condition that would preclude the ability to comply with
post-operative guidelines
9. Moderate to severe renal impairment
10. Pregnant or lactating
11. History of hypersensitivity to any of the test products.
12. Any condition decided as unfit for study by Clinical
investigator |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Change from baseline to 16 weeks in pain intensity measured by Pain VAS Scale (0-100 mm)
2.Time to Return to Pre-Injury Level of Activity
3.Change from baseline to 12 weeks in ESR and CRP levels
4. quality of life
5. Global rating of change
|
Baseline and 12 weeks
|
|
|
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 |
Baseline and 12 weeks |
|
|
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 |
|
Date of First Enrollment (India)
|
05/04/2024 |
| Date of Study Completion (India) |
15/10/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/10/2024 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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 facility for their followup up to end of week 4, Week 8 and Week 12 and any other additional visits if needed.
Primary Outcome
1) Change from baseline to weeks in pain intensity measured by pain VAS Scale 2) Time to return to Pre- Injury level of activity 3) Patient-Reported Physical Function- Activity Limitation scale of Multiple Ligament (MLQoL) Questionnaire 4) Activity Limitation Scale of the Multiple Ligament Qulaity of Life Scale 5) Change from Baseline to 3month a)Hs-C Reactive Protein b)ESR 6) Global Rating of Change (GRC) 7) Changes from baseline to 3 months in Quality of Life Questionnaires
|