Clinical Evaluation of Gokshuradi Guggulu and Nimbadi Churna in Vatarakta (Gout)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 165
- 试验地点
- 2
- 主要终点
- Change in Ayurvedic parameters of Vatarakta
研究概览
简要总结
Vatarakta is the major example of vata vyadhi, caused due to Avarana pathology. It is a disease which is associated with an inheretent abnormality of purine metabolism resulting in over production of uric acid. It is characterized by acute attack pain and swelling of one or more joints. In untreated cases uric acid in the form of monosodium urate gets deposited in the cartilage of joints and later on it causes deformities. The literature enlists a number of Guggulu prayogas in the management of vatarakta. An additional cavernous revise was indispensable to bring out the precise outcome of these products.Keeping these visions in mind, the particular comparative study was performed with Gokshuradi Guggulu and Nimbadi Churna which are explained in the same context, Aim and object of this study is to evaluate their therapeutic efficacy in the patients of Vatarakta ( Gout) along with safety measures by observing adverse events ( AE) if any or Adverse drug reaction ( ADR). The efficacy of these drugs would be assessed by observing the improvement in Subjective parameters ( Clinical symptoms), mean percentage decrease in serum uric acid levels, improvement in SF-36 Health survey score, patients global assessment, physicians global assessment, pain VAS scale and lab parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 25.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either sex aged between 25 and 65 years Confirmed cases of 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: More than one attack of acute arthritis.
- •Maximal Inflammation developing within 1 day of onset.
- •Monoarthritis attack Redness over affected joint Unilateral attack on the first Metatarsophalangeal (Big Toe) joint.
- •Unilateral attack involving Tarsal joint.
- •First Metatarsophalangeal (Big Toe) joint Painful or Swollen.
- •Suspected Tophi Hyperuricemia (≥7.0 mg/dl) Asymmetrical swelling within joint (X Ray) Sub cortical cysts without erosions(X Ray) Negative culture from joint fluid during attack.
- •Willing and able to participate in the study for 14 weeks.
排除标准
- •Age less than 25 yrs or more than 65yrs.
- •History of any trauma/ fractured joint/ surgical/diagnostic intervention with reference to the affected joint(s).
- •Patients with co-morbidities such as Rheumatoid arthritis, Psoriatic arthritis etc.
- •Patients with poorly controlled Hypertension (>160/100 mm of Hg).
- •Patients with poorly controlled Diabetes Mellitus (HbA1c > 8.0%) vi.
- •Patients with evidence of malignancy.
- •Patients with unstable cardio-vascular disease.
- •Known cases of Hypothyroidism or hyperthyroidism.
- •ix.Patients with any concurrent hepatic disorder or Renal Disorders (S.
- •Creatinine >1.2 mg/dl) or Severe COPD.
- •x.Alcoholics/drug abusers.
- •xii.Pregnant/lactating woman.
- •xiii.Any other condition which the Principal Investigator thinks may jeopardize the study.
结局指标
主要结局
Change in Ayurvedic parameters of Vatarakta
时间窗: 3 months
Change in Pain assessment on VAS scale
时间窗: 3 months
次要结局
- Mean percentage decrease in Serum Uric Acid levels from the baseline to the end of study period.(Improvement in SF-36 Health Survey score)