Skip to content

A Study to evaluate the Efficacy and Tolerability of ActiTape in Patients with Pain in Knee Joint due to Mild to Moderate Osteoarthritis

An Exploratory, Randomized, Open Label, Controlled, Cross over Study to Investigate the Efficacy and Tolerability of ActiTape in Patients with Pain in Knee Joint due to Mild to Moderate Osteoarthritis

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/02/003402
Enrollment
14
Registered
2013-02-18
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Mild to Moderate Knee Osteoarthritis

Interventions

Intervention1: Actitape: ActiTape or knee guard group in ratio of 1:1 at Baseline. Patients would continue using ActiTape or knee guard for a period of 6 days. This would be followed by a wash-out f

Sponsors

Nutriworks Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Ambulatory adult patients of either sex aged 30-65 years. 2. Patients with moderate OA of the knee, which can be clinically, categorized as ARA functional Class II and III and with radiological confirmation of Kellgren Lawrence Grade II and III. 3. Patientâ??s functional assessment of overall pain score should be >= 50 mm on a 100 mm VAS for pain at baseline visit. 4. Patients receiving a stable dose of oral calcium or chondrogenic supplements for at least past 1 month and/or a stable dose of NSAIDs for the past 1 week will be eligible for inclusion

Exclusion criteria

Exclusion criteria: 1. Patients of any form of arthritis other than osteoarthritis. 2. Arthroscopy of either knee in the past year. 3. Administration of intra-articular or oral steroids in the past 3 month or intra articular hyaluronic acid in the last 9 months or parenteral use of NSAIDs. 4. Patients requiring immediate surgery for knee. 5. Pregnant / lactating women and women who are planning to get pregnant 6. Recent ( 3 months) participation in a clinical study 7. History of major chronic hepatic, cardiovascular, neurological or immunosuppressive conditions or the presence of any infections 8. Patients with a risk of Deep Vein Thrombosis (DVT) as depicted by a score of >=3 on the Wellâ??s questionnaire 9. Patients with localized trauma to the lower limb 10. Dermatological conditions affecting the lower limb 11. History of skin irritation on application of bandages/tapes 12. A psychiatric condition, chronic alcohol or drug abuse problem as evidenced by withdrawal symptoms 13. Patients otherwise judged by the investigator to be inappropriate for inclusion in the study

Design outcomes

Primary

MeasureTime frame
1.Pain - Visual analogue scale (VAS) 2.Time up-and-go test, Patientsâ?? and Investigator global assessment 3.Unilateral anterior reach test. 4.Medial step-down testTimepoint: At Day 0,Day 3,Day 6,Visit 5,Day 8,Day 11 and Day 14

Secondary

MeasureTime frame
noneTimepoint: none

Countries

India

Contacts

Public ContactDr Navneet Sonawane

Vedic Lifesciences Pvt Ltd

navneet.s@vediclifesciences.com02242025706

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026