CTRI/2018/04/013326招募中3 期
Clinical Efficacy of Kaishore Guggulu and Balaguduchyadi Taila in the Management of Gout (Vatarakta)
CCRAS0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Primary Gouty arthritis fulfilling the diagnostic criteria as recommended by the American College of Rheumatology (1977), it should meet the presence of any six of the following twelve criteria:
- •i. More than one attack of acute arthritis.
- •ii. Maximal inflammation developing within 1 day of onset.
- •iii. Monoarthritis attack
- •iv. Redness over affected 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 (equal or more than 7.0 mg/dl)
- •x. Asymmetrical swelling within joint (X Ray)
- •xi. Sub cortical cysts without erosion (X Ray)
- •xii. Negative culture from joint fluid during attack.
- •Though mentioned as one of the criteria, no synovial fluid examination will be carried out. Diagnosis will be made out of eleven ACR criteria
- •2. Willing and able to participate in the study for 14 weeks.
排除标准
- •1. Age less than 18 yrs or more than 65yrs.
- •2. History of any trauma/ fractured joint/ surgical/diagnostic intervention with reference to the affected joint(s).
- •3. Patients with co-morbidities such as Rheumatoid arthritis, Psoriatic arthritis etc.
- •4. Patients with poorly controlled Hypertension (equal or more than 160/100 mm of Hg).
- •5. Patients with poorly controlled Diabetes Mellitus (HbA1c equal or more than 8.0%)
- •6. Patients with evidence of malignancy.
- •7. Patients with unstable cardio-vascular disease.
- •8. Patients with hypothyroidism having TSH level more than 10mlU/lit and known cases of hyperthyroidism.
- •9. Patients with any concurrent hepatic disorder (defined as liver enzymes SGOT/SGPT more than 2 times of upper normal limit) or Renal Disorders (defined as S.Creatinine more than 1.4mg/dl) or Severe COPD.
- •10. Alcoholics/drug abusers.
- •11. H/o hypersensitivity to any of the trial drugs or their ingredients.
- •12. Pregnant/lactating woman.
- •13. Any other condition which the Principal Investigator thinks may jeopardize the study.
研究者
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