NCT03262792

Assessment of the Efficacy of Andrographis Paniculata in Subjects With Mild to Moderate Osteoarthritis

A Double-blind, Randomized, Placebo Controlled Study to Assess the Efficacy of Andrographis Paniculata in Subjects With Mild to Moderate Osteoarthritis Over a 12-weeks Period

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Vedic Lifesciences Pvt. Ltd. · Industry
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a 12 weeks randomized, double-blind, placebo-controlled clinical study to assess the effect of Andrographis Paniculata at low dose of 300 mg/day and high dose of 600 mg/day in the study population in the age range of 40-70 years and suffering from mild-moderate OA.

Detailed description

In this study, we will assess the efficacy parameters such as effect on various joint health parameters (pain, stiffness and physical activity) by using WOMAC scale. The individuals with knee OA suffer from an increased impact on their activities of daily living, which leads to losses in labor relations, leisure, social life, and sleeping quality, leading also to important decrease in their quality of life. Thus, an important outcome to be evaluated in this study is quality of life of these individuals which will be assessed by SF-36 self-reported questionnaire. One of the aims of this study is therefore to investigate the levels of different dimensions of fatigue in knee OA and to assess changes in fatigue after the treatment targeting pain reduction and physical functioning by the use of FACIT-fatigue questionnaire. Effect of the treatment on rescue medication consumption which is directly proportional to the degree of pain will also be captured via this study. The hepatic (SGOT and SGPT) and renal (serum creatinine) safety biomarkers will be assessed to investigate the effect of chronic use of Andrographis Paniculata on liver and kidneys.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Placebo	Microcrystalline cellulose
DIETARY_SUPPLEMENT	Andrographis Paniculata	Andrographis Paniculata 150 mg
DIETARY_SUPPLEMENT	Andrographis Paniculata	Andrographis Paniculata 300 mg

Timeline

• Start date: 2017-12-13
• Primary completion: 2018-07-30
• Completion: 2018-08-27
• First posted: 2017-08-25
• Last updated: 2021-07-15

Locations

4 sites across 1 country: India