| CTRI Number |
CTRI/2023/05/052160 [Registered on: 01/05/2023] Trial Registered Prospectively |
| Last Modified On: |
31/07/2023 |
| 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 Trumove Gel in reducing muscle and joint Pain |
|
Scientific Title of Study
|
A Randomized, Multi-Centric, Open Label, Comparative, Clinical
Study To Evaluate The Efficacy and Safety Of Trumove Gel In
Patients with Musculo-Skeletal and Joint Pain
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TRUMOVEGEL/03/23 VERSION 1.1 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M Sakthi Balan MD |
| Designation |
Consultant Diabetologist and CI |
| Affiliation |
Thirumalai medical Centre,ki3 |
| Address |
Room no. 1, Thirumalai medical Centre, No 408 Cuddalore Road Nainarmandapan Puducherry
Pondicherry
PONDICHERRY
605004
India |
| Phone |
9443627722 |
| Fax |
|
| Email |
saheerose@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Sakthi Balan MD |
| Designation |
Consultant Diabetologist and CI |
| Affiliation |
Thirumalai medical Centre, ki3 |
| Address |
Room no. 1, Thirumalai medical Centre, No 408 Cuddalore Road Nainarmandapan 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 |
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 |
Venkat_ani2007@yahoo.Co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Tirupati Pharma, India |
| Address |
AmbalaPaonta Sahib Dehradun Rd Pataliyon Himachal Pradesh 173021 |
| 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 S Gopinath MBBS |
Santhi clinic |
54 Ramani nagar
Krishna Nagar main road Chennai
Kancheepuram
TAMIL NADU |
7200131671
gopinathsanthiclinic@gmail.com |
| Dr M Sakthi Balan |
Thirumalai Medical Centre, Puducherry |
Room no.1, Thirumalai Medical Centre, No 408 Cuddalore Road Nainarmandapan Puducherry
Pondicherry
PONDICHERRY |
9443627722
saheerose@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ki3 Ethics Committee for AYUSH |
Approved |
| Ki3 Ethics Committee for AYUSH |
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. Ayurveda Condition: VATABASTIH, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex aged above 18 years.
2. Patients who are able to 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 had been diagnosed with acute and chronic localized musculoskeletal pain and joint pain (arthritis) .
|
|
| ExclusionCriteria |
| Details |
1. Women of child bearing 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. Subject with history of Periarthritis, rheumatoid arthritis
5. Known allergy to compounds of investigational product.
6. Participation in an investigational drug trial in the30 days
prior to the screeningvisit.
7. Patients of vulnerable group (children, lactating mother, elderly
>80 years,handicapped, seriously ill, mentally challenged).
8. 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
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 AT REST and during MOVEMENT
5. Changes in joint/Musculo skeletal pain intensity measured by Pain VAS Scale (0-100 mm)
6. Time interval between onset of pain relief and the need for second application of test / comparator product for pain relief
7. Subjects overall satisfaction for pain relief on a 7- point Likert Satisfaction scale
8.User perception was assessed with a 5- point Likert Satisfaction scale
9. Number of patients requiring rescue medication
10. Changes in C Reactive Protein and ESR
11. Changes in Quality of life Questionnaires (Short Form Health-12) and the WOMAC Pain score and McGill Pain Questionnaire for pain intensity. |
Day 1 [Time frame: 30 seconds, 1 minute, 2 minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes, 120 minutes and hourly upto 8 hours post dose] , day 7 to day 10 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Adverse events and serious adverse events during the study period
Brief clinical examination
|
Day 1, day 7 to day 10 |
|
|
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)
|
05/05/2023 |
| Date of Study Completion (India) |
28/07/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
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 2 groups with 15 in each group.
- Arm 1 - Trumove Gel: 15 study participants
- Arm 2 - Volitra Gel: 15 study participants
|