Clinical study for validating the effectiveness of Tendoease tablet in the rehabilitation of tendonitis.

Phase 3

Conditions: Health Condition 1: M678- Other specified disorders of synovium and tendonHealth Condition 2: M678- Other specified disorders of synovium and tendon

Registration Number: CTRI/2024/03/064125

Lead Sponsor: Meyer Organics Pvt Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Subjects meeting all of the following criteria will be eligible for the study: 1. Male and female subjects aged between 16-50 years (both inclusive);2. Subjects with clinical or ultrasound-confirmed Achilles tendonitis, lateral epicondylitis or patellar tendonitis;3. Subject with relapse cases of tendinosis;4. Subjects with or without comorbidities, if comorbidity exists should be on stable prescription for more than three months;5. Willing to provide consent and willingness for follow-up.

Exclusion Criteria

Subjects meeting any of the following criteria will not be eligible for the study:

1. Preoperative shoulder fracture, irreparable tendon tear (Exceeding 50%),

calcifying tendinitis, shoulder instability, acromioclavicular joint disorder,

infection, neoplasm, symptomatic cervical spine disease, rheumatoid

arthritis or immune disease, gout or uric acid disease;

2. Subjects allergic to the investigational product ingredients;

3. Subjects with any acute illness requiring immediate medical care;

4. Subjects with uncontrolled diabetes/ complicated cardiovascular

diseases/ history of TIA, cerebrovascular accident, stroke or any

revascularization;

5. Known subjects of hepatic or renal impairments;

6. Pregnant, breastfeeding or planning to become pregnant during the study;

7. Any other condition which proves subject unfit for the study

participation.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoints of the study will be to assess: <br/ ><br>1. Changes in pain score on 0-10 visual analog scale (VAS). <br/ ><br>2. Changesin echo texture, thickness, tendon sheath, paratenon, vascularity, <br/ ><br>and tendon movement by radiological investigations.Timepoint: Screening to end of <br/ ><br>the study

Secondary Outcome Measures

Name	Time	Method
The secondary endpoints of the study will be to assess: <br/ ><br>1. Changes in inflammatory markers like IL-6, TNF-alpha, procollagen type <br/ ><br>I N-terminal pro-peptide (PINP), platelet-derived growth factor (PDGF) <br/ ><br>etc. <br/ ><br>2. Changes in health-related quality of life (HRQOL) score. <br/ ><br>3. Changes in symptom grading on a 4-point Linkert scale for swelling, <br/ ><br>tenderness, etc. <br/ ><br>4. Changes in the requirement of rescue medication.Timepoint: Screening to end of <br/ ><br>the study