Efficacy and safety of G-Amrita formulation in the management of high uric acid and gouty arthritis
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- •The change in serum mean uric acid after 8 weeks of therapy when compared to baseline
研究概览
简要总结
Many plant extracts and herbs have been used in the treatment and management of Gout and hyperuricemia since long. Out of these plants, Tinospora cordifolia, Terminalia Chebula, Embica officinalis, Terminalia Bellirica and Tribulus terresteris have been chosen to form formulation for Gout and Hyper uricemia. These contains compounds with anti-prolferative, anti-oxidant, anti-inflammatory activities and is known to help in the management of Gout treatment. Tinospora cordifolia is immensely useful due to the presence of different compounds of pharmaceutical significance belonging to various groups such as alkaloids, diterpenoid lactones, glycosides, steroids, sesquiterpenoids, and phenolics. These compounds possess pharmacological properties, which make it anti-diabetic, antipyretic, antiinflammatory, anti-oxidant, hepato-protective, and immuno-modulatory [6]. T. chebula is supposed to have a significant quantity of gallic acid, ellagic acid, tannic acid, β-sitosterol, ethyl gallate, chebulic acid, ascorbic acid, and mannitol, which are responsible for its various pharmacological properties. In one study, it was seen that in addition to possessing superoxide radical scavenging activity (7]. T. bellerica also inhibited uric acid formation, which was indicative of its XO enzyme inhibitory activity. Tribulus terrestris is a natural herb, also known as Puncture vine or Gokhru, used for treating several diseases and found in many tropical and moderate areas of the world, including the US and Mexico, Mediterranean region, and throughout Asia. T. terrestris is aphrodisiac, antihypertensive, diuretic, and antiurolithiatic in nature T. terrestris significantly reduced the excretion of oxalate, calcium, and phosphate along with decreased levels of blood urea nitrogen, uric acid and creatinine in serum. T. terrestris also reduced hyperoxaluria- caused oxidative stress, and restored antioxidant enzyme activity and their expression profile in kidney tissue. Emblica possess a vast ethno medical history and represents a phytochemical reservoir of heuristic medicinal value. It has been suggested in the scientific literature that consumption of it alleviates arthritic pain and Gout. Many pharmacological studies have shown that this plant extracts having antioxidant, anticarcinogenic, antitumor, antigenotoxic, antigout, and anti-inflammatory activities, and supporting its traditional uses.
Keeping such benefits in view, it was aimed to study effectiveness and safety profile of G -AMRITA in patients with hyper uricemia and /or Gout
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •With the data of serum uric acid level more than 8.0 mg/dl.
排除标准
- •Significant liver or Renal dysfunction, Hematological disease, Oncological disease, or other life threatens disorders.
- •2.Condition that need the management of diuretics or analgesics agent 3.Severe cerebrovascular disease or severe heart disease; 4.Mental diseases such as schizophrenia, depressive disorder, and drug dependence 5.Alcohol abuse or dependence 6.Aspartate aminotransferase (GOT) or alanine aminotransferase (GPT) level 2 times higher than the normal upper limit; 7.Creatinine higher than 2 mg/dl 8.Pregnant, lactating, or planning to become pregnant within 3 months;.
结局指标
主要结局
•The change in serum mean uric acid after 8 weeks of therapy when compared to baseline
时间窗: 0, 4 weeks, 8 weeks
次要结局
- Changes in hemogram (Hb, TLC, DLC)(0, 4 weeks, 8 weeks)
- Change in VAS score
- Change in liver & renal function parameters in blood
