A Clinical Study to Assess the Efficacy and Safety of Amrith Noni Artho Plus in Patients with Gout flare.

Phase 3

Conditions: Health Condition 1: M109- Gout, unspecified

Registration Number: CTRI/2023/10/058982

Lead Sponsor: Valyou Products Private Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1) Male and female participants aged 18 years and over consulting for current Gout flare.

2) Participants have been diagnosed for Chronic Gout by a general practitioner and/or orthopedic physician/surgeon with or without joint aspiration, blood tests, imaging or diagnostic criteria

3) Participants who have no plans to start new treatments during the study period

4) Patients who require anti-inflammatory treatment, do not use anti-inflammatory/analgesic medications on a regular basis, or are unsatisfied with their treatments and want to alter them.

5) Patients ready to give written informed consent and willing to comply the study protocol.

Exclusion Criteria

1) Participants with glucose-6-phosphate dehydrogenase deficiency.

2) Subjects with a history of surgery or gastrointestinal bleed and gastric ulcer.

3) Participants with RA, OA, septic arthritis, during the past 3 months.

4) Participants with uncontrolled medical conditions such as angina, hypertension, cardiovascular diseases, impaired liver function, kidney failure, gallbladder disease, malignancies, neurological diseases, or psychiatric conditions.

5) Participants using other complementary and alternative medicine or any addiction to psychotropic agents and opioids.

6) Prior or active users of a uricase-containing drugs, anticoagulants, NSAID, naproxen or low-dose colchicine.

7) Any history of allergy to any of the drugs/investigational products.

8) Participation in any other clinical trial within 30 days of screening.

9) Pregnant and lactating women and women of childbearing age who do not follow adequate contraceptive measures

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline to end of study in Intensity of pain on a Visual Analogue Scale (VAS)Timepoint: Baseline, Week 12 and Week 24

Secondary Outcome Measures

Name	Time	Method
Change from baseline to end of study in CRP LevelsTimepoint: Baseline, Week 12 and Week 24;Change from baseline to end of study in Health Assessment Questionnaire (HAQ) Pain ScoreTimepoint: Baseline, Week 12 and Week 24;Change from baseline to end of study in Health-related quality of life (HRQOL) using SF-36 QuestionnaireTimepoint: Baseline, Week 12 and Week 24;Change from baseline to end of study in Patient and Physician Global AssessmentTimepoint: Baseline, Week 12 and Week 24;Change from baseline to end of study in Serum Uric Acid levelTimepoint: Baseline, Week 12 and Week 24