An open label randomized controlled trial to evaluate the efficacy of bodhivriksha (Ficus Religiosa) kashaya basti in the management of vatarakta w.s.r. to gouty arthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The proportion of patients showing improvement in the level of sr. uric acid post Basti karma.
研究概览
简要总结
Vatarakta displays characteristics of modern-day gouty arthritis. Crystal arthropathy known as gouty arthritis is typically seen in middle-aged and older men and postmenopausal women. In 1848, Sir Alfred Garrod connected hyperuricemia to gout. The primary symptoms of hyperuricemia, a metabolic precursor of gout, are pain and swelling in the metatarsophalangeal joint and other major joints. The symptoms of gout include excruciating pain, warmth, redness, and tenderness in the joints as well as sensitivity to touch. Biochemically, gout is defined by extracellular fluid urate saturation, which is reflected in hyperuricemia in the blood, with urate concentrations in the plasma or serum above 6.0 mg/dL (or 400 micromol/L), which is the approximate limit of urate solubility. Primary Objective: To assess the effect of Bodhivriksha kashaya Basti karma in the reduction of Sr. Uric Acid level. patient assessment done according to criteria, if fit for trial and consent taken and proceeds with intervention according to patient group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients willing to sign the conset form.
- •Patient between the age sub-group of 30-60 years of either sex.
- •Patients presenting with clinical features of vatarakta.
- •Assessment of gouty arthritis by assessment criteria.(ARA criteria and ACR and EULAR criteria) Patient with chronicity of disease less than 2 years.
- •Serum uric acid range 6.00 mg/dl to 9.00 mg/dl.
排除标准
- •Subjects with chronicity of disease more than 2 years.
- •Subjects of either sex age below 30 years and above 60 years.
- •The patients unfit for Basti Karma.
- •Patients having systematic pathologies like cardiac disease and hypertension.
- •Subjects with uncontrolled diabetes, systemic disorders and endocrine disorders.
- •Patients having tuberculosis of spine, spinal tumors, vertebral fractures, surgical conditions, and auto immune disease like ankylosing spondylitis.
- •Both groups: Rectal prolapse, Fever, Pregnant and lactating mothers etc.
- •Known case of Rheumatoid Arthritis, Psoriatic Arthritis, Patients with renal or hepatic impairment Serum creatinine more than 1.8mg/dl along with Serum Urea more than 60 mg/dl.
- •Patients requiring emergency treatment.
结局指标
主要结局
The proportion of patients showing improvement in the level of sr. uric acid post Basti karma.
时间窗: Ist- 0 Day. | IInd - After the completion of trial. | IIIrd- 10 days after Basti karma
次要结局
- Reduction in the symptoms of patient like sandhi shotha (swelling), sandhi shool (pain),(stadabhta (stiffness) etc. as described in assessment criteria.)
研究者
Nitish
Institute for ayurved studies and research Shri krishana AYUSH university