Clinical study for validating the effectiveness of Tendoease tablet in the rehabilitation of tendonitis.
- 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
- Not Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
- Secondary Outcome Measures
Name Time Method