Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: AKBA ULTRA: route: Oral, Frequency: 2 capsules a day, duration: 90 days.
Control Intervention1: Placebo: Placebo capsules
Sponsors
Ambe Phytoextracts Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients with osteoarthritis of the knee joints X ray screened, with no other known rheumatological condition and who report the following clinical features based on the ACR classification for knee OA. -knee pain on most days of the previous month, -morning stiffness of less than thirty minutes duration -stiffness in resting the joint. 2.Patients who have been on stable medication conventional or complementary, including nutritional medicine for the past three months, but are still getting symptoms incomplete responders. 3.Patients with visual analog scale VAS score that assessed pain during the most painful knee movement had to be more than forty. 4.Patients able to walk and give both verbal and written information regarding the study. 5.Willing to give written informed consent. 6.Patients willing to and able to comply with all trial requirements. 7.Patients who have not participated in a similar investigation in the past four weeks. 8.Female patients with negative UPT. 9.Female patients with child bearing potential must be willing to agree to use effective contraceptive methods while on treatment and for three months after the completion of study. 10. Male and female Volunteers, with age between 40to70 years 11.Patients with functional index more than seven points.
Exclusion criteria
Exclusion criteria: 1. Patients with clinical evidence or known history of severe cardiac, pulmonary, gastrointestinal, renal, hepatic or neurological disorders 2. History of allergy to aspirin or NSAIDs. 3. Patients who have undergone total knee replacement in the contralateral knee within 6 months prior to the screening visit. 4. Patients who have received an intra articular corticosteroid injection in a lower joint during the three months prior to the baseline visit. 5. Patients with isolated lateral compartment disease defined by joint space loss in the lateral compartment only. 6. Patients who have received chondrocyte transplants in any lower extremity joint. 7. Patients with comorbid conditions that restrict knee function. 8. Patients taking treatment with corticosteroids within last 3 months. 9. Patient with infectious arthritis or gout or underlying inflammatory arthropathy or hyperuricemia 10. Patients with recent injury in the area affected by OA of the knee. 11. Patients with abnormal liver or kidney function tests, major abnormal finding on complete blood count, history of coagulopathies, hyperkalemia, pregnancy, lactation 12. Patients with history of peptic ulceration and upper GI hemorrhage 13. Patients with uncontrolled hypertension, congestive heart failure 14. Patients with prior diagnosed malignant tumours 15. Patients having allergy or sensitivity to study drugs and excipients in the formulation. 16. .Participating in a clinical research trial within 30 days prior to screening. 17. Any other health or mental condition that in the Investigatorâ??s opinion may adversely affect the patientâ??s ability to complete the study or its measures or that may pose significant risk to the patient. 18. Female patients who are pregnant, breast feeding, nursing or planning to become pregnant during study participation or did not agree to use an acceptable form of birth control throughout the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of AKBA Ultraâ?¢ in terms of reduction in symptoms of osteoarthritis like joint pain, joint stiffness over a period of 90 days in patients suffering from Osteoarthritis of knee.Timepoint: To evaluate the efficacy of AKBA Ultraâ?¢ in terms of reduction in symptoms of osteoarthritis like joint pain, joint stiffness over a period of 90 days in patients suffering from Osteoarthritis of knee. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety of AKBA Ultraâ?¢ includes several laboratory parameters, hematology, biochemistry and urinalysisTimepoint: At visit 3 and visit 4 | — |
Countries
India
Contacts
Public ContactDr Avinash
Swasthya Integrative Clinic
Outcome results
None listed