A Multimodal Ayurvedic Intervention In The Management Of Primary Osteoarthritis Of Knee - A Single Arm Clinical Study.
Trial Snapshot
- Phase
- Phase 3 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Improvement in Pain in knee joint, Swelling on knee joint, Stiffness, Pain during flexion and extension, Crepitus, Degenerative changes of Primary osteoarthritis.
Study Overview
Brief Summary
Primary Osteoarthritis is most common joint degenerative disease restricting day to day activity of patients due to pain. Treatment provides only symptomatic relief that is for limited duration. This study includes the treatment method from classical Ayurvedic texts. Who are suffering from cardinal and associated symptoms of Primary osteoarthritis satisfying the inclusion & exclusion criteria are selected for the study. The selected subjects are given Hingwastak Churna 5 gm twice a day First morsel of meals with Goghrita for 3 days, followed by incremental administration of Ashwagandha ghrita for 5/7 days(60ml-80ml-100ml-120ml-140ml). After getting Samyaka Snigdha lakshana, Abhyang and Swedana are performed using Nirgundi taila and Baspa sweda, respectively for 8 days and Yoga Basti conducted with Anuvasana basti with Ashwagandha ghrita 120ml/dose and Niruhbasti with Erandmooladi niruh Madhu-160 ml, Lavana-12 gm, Sneha-240 ml, Kalka-80 gm, Kwath-320 ml, Gomutra-160 ml dose adjust according to patient. As per Shuddhi Samsarjan krama provided. Then Rasayana chikitsa with Ashwagandha churna10gm in morning with Godugdha and Triphala churna 10gm at night with warm water is given for 2 month. Total duration of study is 3 months.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 50.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients with classical signs & symptoms of Primary Osteoarthritis of knee.
- •Patient having Nirupstambhi Sandhigatavata Lakshana.
- •Patient’s grade 1 to 3 according Kellgren-Lawrence grading scale will be taken for study.
- •Snehapana, Asthapana and Anuvasana Basti yogya patient.
- •Patients willing to participate in clinical trial.
Exclusion Criteria
- •Patient having Upstambhi Sandhigatavata Lakshana.
- •Patients grade 4 according Kellgren-Lawrence grading scale will be excluded for the study.
- •Snehapana, Asthapana and Anuvasana Basti ayogya patient.
- •Patients with uncontrolled Diabetes mellitus and Hypertension, known case of Heart disease, Kidney disease, Stroke, Liver disease, Pulmonary dysfunction or COPD systemic illness like Rheumatoid arthritis, Gout, Systemic lupus erythematosus, Tuberculosis, AIDS and SIDS etc.
- •which interferes the clinical trial.
- •Patients taking medications like NSAIDs, Corticosteroids, Hormonal therapy, Anti depressants or any other drugs which may affect outcome of the study.
- •Patients with alcohol and tobacco addiction or drug abuse.
Outcomes
Primary Outcomes
Improvement in Pain in knee joint, Swelling on knee joint, Stiffness, Pain during flexion and extension, Crepitus, Degenerative changes of Primary osteoarthritis.
Time Frame: 4 Weeks
Secondary Outcomes
- Improvement in life quality of patient.(Within 3 months.)
Investigators
Dr Komal Sureshbhai Prajapati
G. J. Patel Institute of Ayurvedic Studies and Research