| CTRI Number |
CTRI/2024/08/072905 [Registered on: 22/08/2024] Trial Registered Prospectively |
| Last Modified On: |
24/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of TRUBLISS PAIN RELIEF OIL in patients with joint pain |
|
Scientific Title of Study
|
A randomized, open label, comparative, clinical study to evaluate the efficacy and safety of TRUBLISS PAIN RELIEF OIL in patients with musculo-skeletal and joint pain disorders |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TRUBLISSOIL/15/24 Version: 1.0 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M Sakthi Balan MBBS MD |
| Designation |
Consultant |
| Affiliation |
Ki3 Private Limited |
| Address |
Room No 2, Thirumala Medical Centre, No 408 Cuddalore Road, Nainarmandapam
Pondicherry
PONDICHERRY
605004
India |
| Phone |
9443627722 |
| Fax |
|
| Email |
saheerose@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Sakthi Balan MBBS MD |
| Designation |
Consultant |
| Affiliation |
Ki3 Private Limited |
| Address |
Room No 2, Thirumala Medical Centre, No 408 Cuddalore Road, Nainarmandapam
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 |
No 5/3, Jayalakshmi street, Radha Nagar Chrompet 600044
Chennai
TAMIL NADU
600044
India |
| Phone |
9003109416 |
| Fax |
|
| Email |
drgayathri@ki3services.com |
|
|
Source of Monetary or Material Support
|
| Trubliss Internation, Ground floor, Shop No16, Plot No 3-D wing, Seamist Building, Shree gajanan CHS, RSC-25, Charkop sector-8, Kandivali west, Mumbai 400067 |
|
|
Primary Sponsor
|
| Name |
Trubliss International |
| Address |
Ground Floor, Shop No 16, Plot No-3D Wing, Seamist Building, Shree Gajanan CHS, RSC-25, Charkop Sector-8, Kandivali West, Mumbai-400067 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr G Bhuvanesh |
Sri Ortho Care |
SRI ORTHO CARE
6,Point Care Street, Karamanikuppam, Puducherry
Pondicherry
PONDICHERRY |
8667437604
bhuvaneshg27@gmail.com |
| Dr Sakthi Balan |
Thirumala Medical Centre |
Room No 1, Thirumala Medical Centre, No 408 Cuddalore Road, Nainarmandapam, Puducherry
Pondicherry
PONDICHERRY |
9443627722
saheerose@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| ETHIQUE DE LA NATURE ASSOCIATION |
Approved |
| ETHIQUE DE LA NATURE ASSOCIATION |
Submittted/Under Review |
| Oxymed Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Trubliss pain relief oil, Reference: Ayurveda, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Dr Ortho Oil, Reference: Ayurveda, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex aged above 18 years.
2. Patients who can understand written and/or verbal instructions and are ready to comply with all study requirements with a willingness to participate and give written informed consent voluntarily.
3. Patients who have been diagnosed with acute and chronic localized musculoskeletal pain and joint pain (arthritis) disorders.
|
|
| ExclusionCriteria |
| Details |
1. Women of childbearing potential who are either unwilling or unable to use an acceptable method of birth control to avoid pregnancy during the study period.
2. Subject with active skin lesions or other skin diseases.
3. Subject with history of uncontrolled diabetes
4. Known allergy to compounds of investigational product.
5. Participation in an investigational drug trial in the 30 days prior to the screening visit.
6. Patients of vulnerable group (children, lactating mother, elderly greater than 80 years, handicapped, seriously ill, mentally challenged).
7. History of drug or alcohol abuse during the last 6 months.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Time to onset of relief of pain [Time frame: 0-120 minutes post dose]
2. Time to onset of cooling/warmth/tingling/burning sensation
3. Time to achieve complete relief of pain
4. Reduction in pain score on numeric pain rating scale
7. Time interval between onset of pain relief and the need for second application of
test/ comparator product for pain relief
8. Changes from base line to 2 weeks in following laboratory parameter(s) for
arthritis patients: a. C Reactive Protein and b.ESR
9. Subject’s overall satisfaction for pain relief and User perception
10. Number of patients requiring rescue medication
11.Changes from base line to 2 weeks post dose in Quality of life- Questionnaires |
Baseline and Day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To demonstrate safety and tolerability of study product by Clinical AEs (If any)
Safety and tolerability evaluation criteria
Adverse events and serious adverse events during the study period
Brief clinical examination All the data will be compared between the test and the
comparator. |
Baseline and Day 14 |
|
|
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)
|
23/08/2024 |
| Date of Study Completion (India) |
10/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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
|
Participants will be randomized into two groups of 15 each:
Arm 1: Participants with musculoskeletal and joint pain will use TRUBLISS PAIN RELIEF Oil twice daily
for 2 weeks.
Arm 2: Participants with musculoskeletal and joint pain will use Dr Ortho Oil twice daily for 2 weeks.
Primary Endpoints
1. Time to pain relief onset (0-120 minutes post-dose).
2. Time to onset of cooling/warmth/tingling/burning sensations (0-120 minutes post-dose).
3. Time to complete pain relief (0-120 minutes post-dose).
4. Pain reduction at rest (measured at various intervals up to 8 hours post-dose).
5. Pain reduction during movement (measured at various intervals up to 8 hours post-dose).
6. Change in pain intensity from baseline to 2 weeks (measured by Pain VAS Scale).
7. Time between pain relief onset and need for second application (0-24 hours).
8. Overall satisfaction with pain relief (7-point Likert scale from Day 1 to Day 14).
9. User perceptions of ease of application, stickiness, greasiness, and spread ability (5-point Likert scale
from Day 1 to Day 14).
10. Number of patients requiring rescue medication (Day 1 to Day 14).
11. Changes in laboratory parameters for arthritis (C-Reactive Protein, ESR) from baseline to 2 weeks.
12. Quality of life changes (Short Form Health-12) from baseline to 2 weeks.
Secondary Endpoint
Safety and tolerability, assessed by adverse events (AEs) and serious adverse events (SAEs) during the
study period and brief clinical examinations.
Data will be compared between TRUBLISS PAIN RELIEF OIL and Dr ORTHO OIL. |