Health Condition 1: M255- Pain in joint
Conditions
Interventions
Intervention1: CV-HFG01 Tablets: CV-HFG01 is a polyherbal formulation useful in management of elevated levels of uric acid and associated joint pain. 1 Tablet is to be consumed twice daily after mea
Sponsors
Climic Health Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects of either sex with hyperuricemia, aged between 18 and 65 years (both inclusive) 2.Serum uric acid level >6.0 and 3. Patients not on any hypouricemic agents 4. Confirmed cases of Primary Gouty arthritis fulfilling the diagnosticcriteria as recommended by the American College of Rheumatology(1977) it should meet the presence of any six of the following twelvecriteria: i.More than one attack of acute arthritis. ii.Maximal Inflammation developing within 1 day of onset iii.Monoarthritis attack iv.Redness over effected joint. v.Unilateral attack on the first Metatarsophalangeal (Big Toe) joint. vi.Unilateral attack involving Tarsal joint vii.First Metatarsophalangeal (Big Toe) joint, painful or swollen. viii.Suspected Tophi. ix.Hyperuricemia (more than 6.0 mg per dl) x.Asymmetrical swelling within joint (X Ray). xi.Sub cortical cysts without erosions (X Ray). xii.Negative culture from joint fluid during attack. 5. Willing and able to participate in the study
Exclusion criteria
Exclusion criteria: i.History of any trauma or fractured joint or surgical or diagnostic intervention with reference to the affected joint (s). ii.Patients with a gout flare during screening or baseline visit, patients currently using aspirin or other nonsteroidal anti-inflammatory drugs, diuretics, other medications with known urate-lowering effects iii.Patients with comorbidities such as Rheumatoid arthritis Psoriaticarthritis etc. iv.Patients with poorly controlled Hypertension ( > 160/100 mm of Hg). v.Patients with poorly controlled Diabetes Mellitus (HbA1c more than 8.0 percent) vi.Patients with evidence of malignancy. vii.Patients with unstable cardiovascular disease. viii.Known cases of Hypothyroidism or hyperthyroidism. ix.Patients with any concurrent hepatic disorder (defined as liver enzymes SGOT or SGPT more than 2 times upper normal limit) or Renal Disorders (defined as S. Creatinine more than 1.4 mg per dl)or Severe COPD. x.Alcoholics/drug abusers. xi.History of hypersensitivity to any of the trial drugs or their ingredients. xii.Pregnant or lactating woman. xiii.Any other condition which the Investigator thinks may risk the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate mean percentage decrease in Serum Uric Acid levels from the base line to the end of study period ie 90 days from baseline.Timepoint: To evaluate mean percentage decrease in Serum Uric Acid levels from the base line to the end of study period ie baseline, day 30,day 60 and 90 days from baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Improvement in SF-36 Health Survey score 2.Patients Global Assessment, Physicians global Assessment 3.To evaluate performance of patient on pain VAS scale. Timepoint: Monthly assessment of- 1. Improvement in SF-36 Health Survey score 2. Patients Global Assessment, Physicians global Assessment 3. Performance of patient on pain VAS scale. For baseline, day 30, day 60 and day 90. | — |
Countries
India
Contacts
Public ContactMr Prateek Shastrakar
Climic Health Pvt Ltd
Outcome results
None listed