An Open Label, Single arm, Clinical trial to assess the Safety and Efficacy of CV-HFG01 Tablets in management of Hyperuricemia and associated pain in gout. - CV-HFG01

Climic Health Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Subjects of either sex with hyperuricemia, aged between 18 and 65 years (both inclusive)
•2.Serum uric acid level >6.0 and <12.0 mg/dL
•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

•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.

发起方

Climic Health Pvt Ltd