| CTRI Number |
CTRI/2023/09/057515 [Registered on: 12/09/2023] Trial Registered Prospectively |
| Last Modified On: |
03/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Collashot C2 Plus in
osteoarthritis patients |
|
Scientific Title of Study
|
A case study to evaluate the efficacy and safety of Collashot C2 Plus in
osteoarthritis patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| COLLASHOT /12/23 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 |
KI3 |
| Address |
Thirumalai Medical Centre,
Room No 1, Thirumalai Medical Centre, No 408, Cuddalore Road Nainarmandapam 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 |
KI3 |
| Address |
Thirumalai Medical Centre,
Room No 1, Thirumalai Medical Centre, No 408, Cuddalore Road Nainarmandapam Puducherry
Pondicherry
PONDICHERRY
605004
India |
| Phone |
9443627722 |
| Fax |
|
| Email |
saheerose@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayathri Sivakumar |
| Designation |
CEO |
| Affiliation |
KI3 |
| Address |
KI3,Room No:1, KI3 Office, Regus Centre Level 2 Altius Block No 1 SIDCO Industrial Estate, Chennai
Chennai
TAMIL NADU
600044
India |
| Phone |
9003109416 |
| Fax |
|
| Email |
drgayathri@ki3services.com |
|
|
Source of Monetary or Material Support
|
| INNOVCARE LIFESCIENCES PVT. LTD. |
|
|
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, Thirumalai Medical Centre, No 408 Cuddalore Road Nainarmandapan Puducherry
Pondicherry
PONDICHERRY
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: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Collashot C2 Plus capsule.
Commiphora myrrha extract 4% (MyrLiq) 100 mg
Choline (as ch-OSA) 60 mg
Curcuma longa extract (CurQlife) 50 mg
Boswellia serrata extract (60%) 50 mg
Native (Undenatured) Collagen Type II
(Collavant n2) 40 mg
Sodium Hyaluronate 40 mg |
One capsule to be taken once daily after food in the morning for 3 months. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Have osteoarthritis (OA) of the knee joint based on American College of Rheumatology (ACR)
criteria and confirmed with X-rays and ACR functional class of III and with grade 3 or 4 as per
Kellgren and Lawrence classification system.
2. Have been on stable dose of prescription Nonsteroidal Anti- Inflammatory Drugs (NSAIDS), or
acetaminophen of at least 2000 mg per day for at least 20 days in the past month.
3. Pain defined by a level of greater than or equal to 30 mm on a 100 mm Visual Analogue Scale
(VAS)
4. Patient should have not participated in any other clinical trial during the past 3 months.
5. Participants, who are willing to give written, signed and dated informed consent to participate in
the study. |
|
| ExclusionCriteria |
| Details |
1. Arthritis of the knee from other causes
2. Uncontrolled hypertension or diabetes
3. Have OA pain that requires treatment with potent opioids, systemic corticosteroids, intra-
articular injections, duloxetine, or venlafaxine
4. Moderate to severe renal impairment
5. Pregnant or lactating
6. Received any other investigational medicine within 7 days prior to screening which can
interfere with investigational product activity
7. Suffering from any illness which will interfere with present study as decided by clinical
investigator
8. History of hypersensitivity to any of the test products.
9. 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. VAS pain score
2. WOMAC scoring
3. ESR, CRP and C-telopepetide
4. OMERACT-OARSI
5. Quality of life |
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
|
N/A |
|
Date of First Enrollment (India)
|
15/09/2023 |
| Date of Study Completion (India) |
02/01/2024 |
| 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 daily orally for 12 weeks. Subjects will be asked to visit clinical facility/institution for their followup at the end of week 4, week 8 and week 12 and any other additional visits if needed.
Primary and Secondary Outcome
1)McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale 2) Pain VAS Scale 3) Hs-C Reactive Protein 4) ESR and C Telopeptide 5) Patient’s Global Assessment of Osteoarthritis 6) Number of Participants with a response rate measured by the Outome Measures for Rheumatology Committee and Osteoarthritis Research Society International Standing Committee for Clinical Trials Response Criteria Initiative (OMERACT-OARSI) 7) Quality Life Questionnaires 8) XRay-Pre and Post |