Health Condition 1: M180- Bilateral primary osteoarthritis of first carpometacarpal joints
Conditions
Interventions
Intervention1: KAL-HS-01 Arishtam: Dosage : Arishtam
Dose: 60 ml per day (Morning 30 ml and evening 30 ml after food)
Duration: 8 weeks
Control Intervention1: Nil (Open label study): Nil
Sponsors
Kerala Ayurveda Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Willing to give informed consent. 2. Healthy Indian male/ female volunteer aged between 18-65 years. 3. Must be able to adhere to the study visit schedule and other protocol requirements. 4. Willing to complete the questionnaires for the total duration of 45 days. 5. Joint and muscle pain in the last 1 month. 6. Willing to avoid usage of pain relievers like Ibuprofen, Acetaminophen or any other NSAIDs etc. during the study duration. 7. Agree not to use any medication (prescription and over the counter), including vitamins and minerals, during the course of this study
Exclusion criteria
Exclusion criteria: 1. Pregnant or Breast feeding. 2. Inability to provide voluntary consent 3. Patients with pre existing severe systemic disease like uncontrolled diabetes hypertension Cardiac illness etc necessitating long term medication 4. Evidence of significant uncontrolled co morbid disease which in the investigators opinion would jeopardize patient participation 5. Any clinically significant medical history medical finding or an ongoing medical or psychiatric condition exists which in the opinion of the Investigator could jeopardize the safety of the subject, impact validity of the study results or interfere with the completion of study according to the protocol 6. History of cancer, including solid tumors, hematologic malignancies and carcinoma in situ 7. Use of any anti psychotic drugs for one week prior to Baseline 8. Subjects who abuse drugs or alcohol drug screening not required 9. Use of any investigational medication within 4 weeks prior to start of study drug. 10. Greater than moderate alcohol use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy/ perceived benefit of JOINT CARE in the following: 1.RHEUMATIC PAIN 2.JOINT SWELLING 3.MUSCLE PAIN 4.JOINT & MUSCLE STIFFNESS. â?¢% Improvement in the knee pain assessed through VAS [Time: Day 0 to Day 56] â?¢% Change in the joint swelling assessed by the Investigator [Time: Day 0 to Day 56] Timepoint: Day 0 to Day 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ % Improvement in the muscle pain assessed through VAS [Time: Day 0 to Day 56] â?¢ % Improvement in the joint and muscle stiffness assessed by the investigator [Time: Day 0 to Day 56] Timepoint: Day 0 to Day 56 | — |
Countries
India
Contacts
Public ContactDrSarala Samuel
Kerala Ayurveda Ltd.
Outcome results
None listed