Effect Of Trumove Gel in reducing muscle and joint Pain

Phase 3

Completed

Conditions: Acquired deformity of musculoskeletal system, unspecified. Ayurveda Condition: VATABASTIH,

Registration Number: CTRI/2023/05/052160

Lead Sponsor: Tirupati Pharma, India

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

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 30

Inclusion Criteria

Patients of either sex aged above 18 years.
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.
Patients who had been diagnosed with acute and chronic localized musculoskeletal pain and joint pain (arthritis) .

Exclusion Criteria

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.
Subject with active skin lesions or other skin diseases.
Subject with history of uncontrolled diabetes 4.
Subject with history of Periarthritis, rheumatoid arthritis 5.
Known allergy to compounds of investigational product.
Participation in an investigational drug trial in the30 days prior to the screeningvisit.
Patients of vulnerable group (children, lactating mother, elderly >80 years,handicapped, seriously ill, mentally challenged).
History of drug or alcohol abuse during the last 6 months.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
3. Time to achieve complete relief of pain	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
4. Reduction in pain score on numeric pain rating scale AT REST and during MOVEMENT	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
6. Time interval between onset of pain relief and the need for second application of test / comparator product for pain relief	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
7. Subjects overall satisfaction for pain relief on a 7- point Likert Satisfaction scale	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
2. Time to onset of cooling/warmth/tingling/burning sensation	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
1. Time to onset of relief of pain	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
5. Changes in joint/Musculo skeletal pain intensity measured by Pain VAS Scale (0-100 mm)	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
8.User perception was assessed with a 5- point Likert Satisfaction scale	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
9. Number of patients requiring rescue medication	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
10. Changes in C Reactive Protein and ESR	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
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 Measures

Name	Time	Method
Adverse events and serious adverse events during the study period	Brief clinical examination

Trial Locations

Locations (2): Santhi clinic
🇮🇳
Kancheepuram, TAMIL NADU, India
Thirumalai Medical Centre, Puducherry
🇮🇳
Pondicherry, PONDICHERRY, India
Santhi clinic
🇮🇳Kancheepuram, TAMIL NADU, India
Dr S Gopinath MBBS
Principal investigator
7200131671
gopinathsanthiclinic@gmail.com