CTRI/2022/07/044494CompletedPhase 3
A prospective, open label study to evaluate the safety, efficacy of KAL-HS-01 in Reducing Symptoms of arthritis (Sandhigata Vata) and in maintaining Optimal Joint Health
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Kerala Ayurveda Limited
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility 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
- •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
Investigators
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