An open lebel comparative clinical study to evaluate the effect of kokilaksha kashaya with and without kaishora guggulu in the management of vatarakta with specific reference to Gouty Arthritis.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Reduction in sandishoola/severity of joint pain measuredwith VAS Scale
研究概览
简要总结
Management of Vatarakta (Gouty Arthritis) in the age group 16 to 60 yrs. 40 patients diagnosed with Vatarakta Will be divided into two groups of 20 patients. Kokilaksha kashaya 20ml and Kaishor Guggulu 500mg along with luke warm water will be given twice a day for 30days to Goup A patients internally and For Group B only Kokilaksha kashaya 20ml along with luke warm water twice a day will be given for 30 days.
Patients will be assessed for primary outcome reduction in Sandhishoola, Sandhishotha and improvement in range of movements. Secondary outcome measure will be improvement in overall signs and symptoms of vatarakta and improvement of quality of life of the patient. grading will be given for subjective and objective criteria after the assessment on 1stday-before the treatment , 15th day-after the treatment and follow up will be done on 31stday . The data obtained will be analysed statistically with suitable method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 16.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients having cardinal signs and symptoms of Vatarakta are Sandi Shoola, Sandi Shotha, Vaivarnya, Sthambana, Chimchimayana, Sheeta pradwesha, Ugradaha, Sankoch of dhamani, anguli and Sandi.
- •2.On irregular medications and irrespective of discrimination of race, religion and sex.
- •3.Patients fulfilling the diagnostic criteria of Vatarakta preferred serum uric acid above 7.5mg/dl to 15mg/dl.
排除标准
- •1.patients with diabetes mellitus, hypertension, congenital abnormalities.
- •Unstable medical or psychiatric illness.
- •3 history of seizures.
- •Pregnant women, lactating mother and alcoholic.
- •5 symptoms suggestive of Vatavyadhi other than Vatarakta.
- •6.Vatarakta with Upadrava.
- •Patient having serum uric acid less than 3.5 mg/dl and more than 15mg/dl.
结局指标
主要结局
Reduction in sandishoola/severity of joint pain measuredwith VAS Scale
时间窗: 1st day i.e before treatment, 15th day after giving treatment and on 30th day i.e 4 weeks.
Reduction in Sandi Shotha measured in cms
时间窗: 1st day i.e before treatment, 15th day after giving treatment and on 30th day i.e 4 weeks.
Improvement in the range of movements of joints measured with Goniometer reading
时间窗: 1st day i.e before treatment, 15th day after giving treatment and on 30th day i.e 4 weeks.
次要结局
- Improvement in the overall signs and symptoms of Vatarakta and improvement in the quality of life.(1st day i.e before treatment)
研究者
Dr Jyoti Maruti Sayanak
Dhanwantari Ayurveda College Hospital and PG Research Centre Siddapur