Randomized controlled clinical trial to evaluate the efficacy of Dhatryadi kwatha in the management of Vatarakta(Gout)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Sandhiruja (Pain) Sparshasahatva(Tenderness) Sandhidaha(Burning sensation)
研究概览
简要总结
Due to rapid modernisation in India fast food culture, stressful and sedentary lifestyle the disturbance in samavastha of dosha’s cause various diseases and Vatarakta is one of them.
Vatarakta is made of two words Vata and Rakta .The disease which is caused by aggaravated Vata and vitiated Rakta due to its own causative factors is termed as Vatarakta. It is also known as Khudaroga, Vata-balasa, Vatashonita and Adhyavata. Vatarakta is one of the main articular joint metabolic disease which is characterized by severe pain, tenderness, inflammation in the affected joints .Due to critic nature of disease, people became disabling in the routine activities and ultimately it affects the quality of life.
The chief complaints of patient is severe joint pain with onset from hasta-pada angustha mula and then it migrates to other joints in a way similar to Akhuvisha.
The above clinical presentation to textual reference of the disease can be easily correlate with Gout explained in modern medicine. As we know Gout results due to deposition of monosodium urate crystal (MSU) in joints secondary to hyperuricemia, which results due to inappropriate purine metabolism. Hyperuricemia may occur either due to excessive production or decreased excretion of uric acid .The most common type of inflammatory monoarthritis is caused by monosodium urate crystals characterized by pain or swelling of 1st metatarsal joint and then progress to other joints of body.
NULL HYPOTHESIS - Thereis no significant role of DHATRYADI KWATHA inmanagement of Vatarakta.
ALTERNATE HYPOTHESIS - Thereis significant role of DHATRYADI KWATHA inmanagement of Vatarakta.
The study will be conducted on 92 patients with 46 patients of trial group will be treated with Dhatryadi kwatha and the other 46 patients of Control group will be treated with Kaishor guggul and the result will be conducted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 30.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Patients irrespective of gender will be selected. 2 Patients of age group 30 years to 50 years will be selected. 3 Patient having clinical signs and symptoms of Vatarakta as described in Charak chikitsa.
- •Sandhiruja (Pain)
- •Sparshasahatva(Tenderness)
- •Sandhidaha(Burning sensation)
- •Sandhishotha(Swelling)
- •Sandhistabdhata(Stiffness) 4 Patients showing signs and symptoms of Vatarakta less than 1 year. 5 Patient having Sr. uric acid level.
- •Above 7 mg/dl in male above 6 mg/dl in female.
排除标准
- •Patients below 30 years and above 50 years of age.
- •Patients with any known case of inflammatory joints disorders other than gout – Rheumatoid arthritis, Tubercular arthritis, Osteoarthritis, SLE.
- •Patients with diagnosed cases of any systemic metabolic disorder viz. Hypertension, Diabetes mellitus, Hypothyroidism, Hyperthyroidism.
- •Patients having Sr. uric acid level : In male.
- •less than 7 mg/dl and greater than 10 mg/dl In female – less than 6 mg/dl and greater than 10 mg /dl.
- •Patients with known case of Vatarakta with chronicity more than 1 year.
- •Pregnant and lactating women.
结局指标
主要结局
Sandhiruja (Pain) Sparshasahatva(Tenderness) Sandhidaha(Burning sensation)
时间窗: 21 days
this lakshanas will be decreased
时间窗: 21 days
次要结局
- Sandhishotha(Swelling)(Sandhistabdhata(Stiffness) this lakshanas will be decreased)