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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
108
Microcrystalline cellulose
Andrographis Paniculata 150 mg
Andrographis Paniculata 300 mg
Nidaan Hospital, A/1, Adinath Society, Near Dosti Estate, Opposite Antop Hill Post Office, Wadala(West)
Mumbai, Maharashtra, India
Ayush nursing Home, Gaurav vista, Gaurav Garden,BunderpakhadiRoad, Kandivali(West)
Mumbai, Maharashtra, India
Siddhant Clinic, Shop No. 17, Lenyadri Cooperative Housing Society, Sector 19A, Nerul(East),Navi Mumbai -400706, Maharashtra
Mumbai, Maharashtra, India
Orthopaedic Clinic, 213, 2nd floor, Shiv Centre, Plot no. 72, Sector-17, Vashi, Navi Mumbai.
WOMAC pain score
Change in WOMAC pain score
Time frame: 84 days
WOMAC stiffness score
Change in WOMAC stiffness score
Time frame: 84 days
WOMAC physical function score
Change in WOMAC physical function score
Time frame: 84 days
SF-36
Change in SF-36's various component scores.
Time frame: 84 days
FACIT score
Change in FACIT score
Time frame: 84 days
Rescue medication consumption
Change in rescue medication consumption.
Time frame: 84 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Mumbai, Maharashtra, India