NCT04833946

To Assess the Effect of 336 Days Exposure of Paractin® on Pain & Disease Progression in Patients Suffering From Osteoarthritis of Knee Joint.

A Double-blind, Randomized, Placebo-controlled Study to Assess the Effect of 336 Days Exposure of Paractin® on Pain & Disease Progression in Patients Suffering From Osteoarthritis of Knee Joint.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Vedic Lifesciences Pvt. Ltd. · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Accepted

Summary

Sponsor aimed to study hydroalcoholic extract of Andrographis paniculata (for its effect on OA disease progression in OA patients with moderate to severe knee OA. Hydroalcoholic extract of Andrographis paniculata (standardized for 50% bioactive andrographolides).Andrographis paniculata may have an effect on increasing the expression of collagen type II protein and also mitigate the migration of inflammatory cells or angiogenesis

Detailed description

Sponsor aimed to study hydroalcoholic extract of Andrographis paniculata (for its effect on OA disease progression in OA patients with moderate to severe knee OA. Hydroalcoholic extract of Andrographis paniculata (standardized for 50% bioactive andrographolides). It has been evaluated in clinical studies for its anti-inflammatory and anti-oxidant activities. Although the potential cartilage regenerative mechanism of Andrographis paniculata is unknown, Sponsor believe that Andrographis paniculata may have an effect on increasing the expression of collagen type II protein and also mitigate the migration of inflammatory cells or angiogenesis. In the present study, knee morphometrics (joint space narrowing of tibiofemoral joint, and cartilage thickness at the femur, tibia and patella compartments), cartilage turnover (serum COMP levels), bone turnover (serum Bone specific alkaline phosphatase) along with symptomatic relief (Using mWOMAC) in patients with primary knee OA over a period of 336 days will be evaluated.

Conditions

• Knee Osteoarthritis (Knee OA)

Interventions

Type	Name	Description
OTHER	Andrographis paniculata [150 mg]	One capsule to be taken orally, 30 minutes after breakfast \& 30 minutes before bedtime
OTHER	Microcrystalline Cellulose (MCC)	One capsule to be taken orally, 30 minutes after breakfast \& 30 minutes before bedtime

Timeline

• Start date: 2021-03-13
• Primary completion: 2024-02-20
• Completion: 2024-02-20
• First posted: 2021-04-06
• Last updated: 2025-05-31

Locations

5 sites across 1 country: India