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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Microcrystalline cellulose |
|
| Andrographis Paniculata 150 | Active Comparator | Andrographis Paniculata 150 mg |
|
| Andrographis Paniculata 300 | Active Comparator | Andrographis Paniculata 300 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | Microcrystalline cellulose |
| |
| Andrographis Paniculata |
| Measure | Description | Time Frame |
|---|---|---|
| WOMAC pain score | Change in WOMAC pain score | 84 days |
| Measure | Description | Time Frame |
|---|---|---|
| WOMAC stiffness score | Change in WOMAC stiffness score | 84 days |
| WOMAC physical function score | Change in WOMAC physical function score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shalini Srivastava, MD | Vedic Lifesciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nidaan Hospital, A/1, Adinath Society, Near Dosti Estate, Opposite Antop Hill Post Office, Wadala(West) | Mumbai | Maharashtra | 400031 | India |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| C000713167 | Andrographis paniculata extract |
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Randomized, double-blind, placebo controlled, parallel groups study.
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| Dietary Supplement |
Andrographis Paniculata 150 mg |
|
| Andrographis Paniculata | Dietary Supplement | Andrographis Paniculata 300 mg |
|
| 84 days |
| SF-36 | Change in SF-36's various component scores. | 84 days |
| FACIT score | Change in FACIT score | 84 days |
| Rescue medication consumption | Change in rescue medication consumption. | 84 days |
| Ayush nursing Home, Gaurav vista, Gaurav Garden,BunderpakhadiRoad, Kandivali(West) | Mumbai | Maharashtra | 400067 | India |
| Siddhant Clinic, Shop No. 17, Lenyadri Cooperative Housing Society, Sector 19A, Nerul(East),Navi Mumbai -400706, Maharashtra | Mumbai | Maharashtra | 400706 | India |
| Orthopaedic Clinic, 213, 2nd floor, Shiv Centre, Plot no. 72, Sector-17, Vashi, Navi Mumbai. | Mumbai | Maharashtra | India |
| D012216 |
| Rheumatic Diseases |