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Clinical trial on pain related to joints

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

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/067777
Enrollment
40
Registered
2024-05-21
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M109- Gout, unspecified

Interventions

None listed

Sponsors

Kerala Ayurveda Limited Head
Lead Sponsor

Eligibility

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
1.Percentage change in the uric acid levels 2.Percentage Improvement in the pain due to uric acid accumulation (Sandhi shola) assessed through VAS 3.Percentage Change in the joint swelling (Sandhi sopha) assessed by the Investigator and By taking prakriti of the subjects. 4.Percentage Change in Gout impact using GAQ2.0 Questionnaire Timepoint: Day and Day 42

Secondary

MeasureTime frame
Assessment of Change in Quality of life using WHOQOL -100Timepoint: Day and Day 42

Countries

India

Contacts

Public ContactJayashree M

Kerala Ayurveda Ltd.

jayashree@keralaayurveda.us9880677814

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026