Health Condition 1: M678- Other specified disorders of synovium and tendon Health Condition 2: M678- Other specified disorders of synovium and tendon
Conditions
Interventions
Intervention1: Tendoease tablet: One Tendoease tablet twice daily 30 minutes after lunch and dinner for 90 days.
Control Intervention1: Placebo tablet: One Placebo tablet twice daily 30 minutes after
Sponsors
Meyer Organics Pvt Ltd
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints of the study will be to assess: 1. Changes in pain score on 0-10 visual analog scale (VAS). 2. Changesin echo texture, thickness, tendon sheath, paratenon, vascularity, and tendon movement by radiological investigations.Timepoint: Screening to end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints of the study will be to assess: 1. Changes in inflammatory markers like IL-6, TNF-alpha, procollagen type I N-terminal pro-peptide (PINP), platelet-derived growth factor (PDGF) etc. 2. Changes in health-related quality of life (HRQOL) score. 3. Changes in symptom grading on a 4-point Linkert scale for swelling, tenderness, etc. 4. Changes in the requirement of rescue medication.Timepoint: Screening to end of the study | — |
Countries
India
Contacts
Public ContactVarsha Chhabria
Meyer Organics Pvt Ltd
Outcome results
None listed