Health Condition 1: M678- Other specified disorders of synovium and tendon
Conditions
Interventions
Intervention1: T Heal Capsules
(Combination of Mucopolysaccharides, Collagen Type 1 and Vitamin C): One capsule twice daily for 90 days
Control Intervention1: Placebo: One capsule twice daily for 90 d
Sponsors
Alkem Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients 18 to 70 years of age (both inclusive). 2. Patients with clinical diagnosis of Achilles tendinopathy or Plantar Fasciitis. 3. Patients with VAS score >= 40 (when active) at baseline. 4. Patients willing to provide written informed consent and comply with the protocol requirements
Exclusion criteria
Exclusion criteria: 1. Patients with known hypersensitivity to mucopolysaccharides, collagen type 1 or vitamin C. 2. Patients who have used NSAIDs or any other analgesic in last 3 days. 3. Patients with clinically suspected systemic disease (spondyloarthropathy, gout, rheumatoid arthritis, sarcoidosis) or a neurological disorder. 4. Patients with other clinical suspicion of other musculoskeletal (insertional disorders and tendon rupture) injuries or systemic inflammatory disorders. 5. Patients with history of use of specific medications that can cause tendinopathy (fluoroquinolones). 6. Patients who have used systemic steroids in last 3 months. 7. Patients who have received intralesional PRP or any other local therapy for management of tendinopathy. 8. Patients with history of surgery (affected leg), history of arthritis, peripheral neuropathy or uncontrolled diabetes. 9. Patients with history of gastrointestinal disorder like gastrointestinal ulcer / gastrointestinal bleeding. 10. Pregnant and lactating women or the women of child bearing age who are not practicing effective method of contraception. 11. Patients with continuing history of alcohol and/or drug abuse. 12. Participation in another clinical trial in the past 3 months. 13. Any other reason for which the investigator feels that the patient should not participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in VAS score during activityTimepoint: day 15, 30, 60 and 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in VAS score at restTimepoint: day 15, 30, 60 and 90;Change in VISA-A score in patents of Achilles TendinopathyTimepoint: day 15, 30, 60 and 90;Change is AOFAS score in patients of Plantar FasciitisTimepoint: day 15, 30, 60 and 90;No. of analgesic tablets consumed in the two groupsTimepoint: 15, 30, 60 and 90;Overall assessment by the patients in the two groupsTimepoint: end of the study | — |
Countries
India
Contacts
Public ContactDr Roshan Pawar
Alkem Laboratories Limited
Outcome results
None listed