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Evaluation of TriNyros for safety & efficacy in osteoarthritis of knee

Benefits and risk assessment of TriNyros in osteoarthritis of knee: BRATO STUDY - Brato study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/02/031028
Enrollment
150
Registered
2021-02-05
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: M179- Osteoarthritis of knee, unspecified

Interventions

Intervention1: Trinyros: 1. Rosehip extract (Rosa canina) 275mg 2. Iridoforce- Devilâ??s claw extract (Harpagophytum procumbens) 100mg 3. Aflapin- Shallaki extract (Boswellia serrata) 50mg Dose of t

Sponsors

Nutragenix Healthcare Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Clinical diagnosis of osteoarthritis of the knee based on the American College of Rheumatology (ACR) criteria At least moderate pain in the knee (rated at 5 or greater by the subject on a visual analogue scale) during the most painful knee movement during the last month. Patient willing to give consent and comply with study procedures and requirements

Exclusion criteria

Exclusion criteria: Individuals suffering from any of the following conditions will be excluded from the study: 1. Pregnant and lactating women 2. Acute joint trauma of the knee 3. Patients with uncontrolled diabetes and hypertension, any severe cardiac, renal and hepatic disease or End organ damage 4. History of allergy against herbal products or NSAIDs 5. Subjects who cannot be relied upon to comply with instructions

Design outcomes

Primary

MeasureTime frame
The WOMAC Score, European Quality of Lifeâ??5 Dimensions (EQ5-D), Clinical assessment of symptoms: palpation, limitation of mobility, joint crepitus, swelling and redness, Patient Global Assessment of pain and use of rescue medication)Timepoint: Day 0,15, 30, 60 and 90

Secondary

MeasureTime frame
1. Blood investigation: CBC, ESR, BSL Random, SGOT, SGPT, Urea, Creatinine, Urine routineTimepoint: Day 0 & 30

Countries

India

Contacts

Public ContactDr Sachin Tapasvi

Orthopedic Speciality Clinic

drsachintapasvictri@gmail.com8928405250

Outcome results

None listed

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