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Clinical Trials/CTRI/2024/05/067777
CTRI/2024/05/067777
Not yet recruiting
Phase 1

A Prospective, Open Label Clinical study to evaluate the safety and efficacy ofKAL-PRD-01 tablets in volunteers suffering from Gout (Vatarakta). - NI

Kerala Ayurveda Limited Head0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: M109- Gout, unspecified

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Health Condition 1: M109- Gout, unspecified
Sponsor
Kerala Ayurveda Limited Head
Status
Not yet recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
Kerala Ayurveda Limited Head

Eligibility Criteria

Inclusion Criteria

  • •1\.Willing to give informed consent.
  • •2\.Otherwise 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\.History or currently suffering from joint pain (due to uric acid).
  • •6\.Agree not to use any medications for Osteoarthritis during the study duration.
  • •7\.Willing to avoid usage of pain relievers like Ibuprofen, Acetaminophen or any other NSAIDs etc. during the study duration.
  • •8\.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 preexisting severe systemic disease 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\.Use of any diuretics
  • •7\.History of cancer, including solid tumors hematologic malignancies and carcinoma in situ
  • •8\.Use of any anti\-psychotic drugs for one week prior to Baseline.
  • •9\.Subjects who abuse drugs or alcohol drug screening not required.
  • •10\.Use of any investigational medication within 4 weeks prior to start of study drug.

Outcomes

Primary Outcomes

Not specified

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