跳至主要内容
临床试验/CTRI/2018/04/013326
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

发起方
CCRAS

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