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临床试验/CTRI/2023/03/050758
CTRI/2023/03/050758招募中4 期

Efficacy and safety of G-Amrita formulation in the management of high uric acid and gouty arthritis

Shree Dhanwantri Herbals1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年3月20日最近更新:

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

研究者

发起方
Shree Dhanwantri Herbals
申办方类型
Pharmaceutical industry-Indian

研究点 (1)

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