跳至主要内容
临床试验/CTRI/2018/04/013527
CTRI/2018/04/013527进行中(未招募)2 期

A Clinical Study to Evaluate the Effect of Ayurvedic Formulationsin the management of Kamla (Jaundice) w.s.r. to Impaired Liver Function

Principal1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2017年10月6日最近更新:

试验速览

阶段
2 期
状态
进行中(未招募)
发起方
Principal
入组人数
15
试验地点
1
主要终点
awaited

研究概览

简要总结

Kamala is one of the important, common clinicalentities in Ayurveda whose description appears to be most comprehensive andincorporates the disorders of Hepato-Biliary system of Modern medicine. Inayurvedic literature Kamla has been mentioned as  sequel of PanduRoga. It occurs when Pandurogitakes more PaitikAahar-Vihar. Jaundice is a yellowish discoloration of tissueresulting from the deposition of bilirubin. These occur only in the presence ofserum hyperbilirubinemia and is a sign of liver disorder.

‘‘Suchimukhakrimiâ€affecting the liver cells directly specifically mentioned in 5thchapter of HareetSamhita. It can be correlated,thesekrimiswith theviruses those are responsible for Viral Hepatitis. Considering the clinicalpresentation of Kamala, seems near to hepatitis described in modernmedicine. Inflammation of liver (Hepatitis) can be traced to many differentcauses, including viral infections, alcohol,fat accumulation in the liver,     malunctioning immune system, exposure tochemicals and other toxins and certain drugs.

Liveris considered to be one of the vital organs which help in maintaining thehealth of body. Yakrit (liver) is being described right from the Vedic period.Modern lifestyles can over stress the liver and make it malfunctioning. Theliver diseases have remained a challenge to medical profession since many ofthe liver disease may ultimately lead to irreversible changes. Liver functiontests along with liver enzymes constitute groups of tests used to determine thestate of liver function in a patient. Liver function tests are particularlyuseful as a screening tool and can be a great benefit when looking for anyhepatic dysfunction.

Ayurvedicsystemof medicine recommends various crude drugs for the treatment of hepaticdisorders. No significant and safe hepato-protective drugs are available inmodern therapeutics which can stimulate the liver function, protect it fromdamage or help in improving the function of hepatic cells.The nature hasbestowed some plants with the property to prevent,treat and cure hepatic disturbanceswith the interception of fewer side effects.

Taking into consideration these pointspolyherbal preparations having an herbal mixture of rare herbs to improve Kamlaand liver function named as Liver Tone and Trivrita (Nishotha) Churna have beenchoosen to seen their effect on the patients of Kamla (Jaundice). So, theclinical study was planned to evaluate the hepatoprotective effect of thisherbal formulation.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
10.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patient willing to undergo trial and ready to give written consent.
  • Between the age group of 10 years and 70 years.
  • Patients presenting with signs and symptoms of Kamla and those having impaired liver function test.
  • Clinical evidence of infective hepatitis,cirrhosis of liver,parenchymal disease of liver,alcoholic liver disease etc.

排除标准

  • 1.Patients not willing for trial.
  • 2.Patients who have developed malignancy and acute hepatocellular failure.
  • 3.Patient in whom there is need of surgery, in case of obstructive jaundice.
  • 4.Patients who have inherited hemoglobinopathy such as sickle cell anemia or thalassemia.

结局指标

主要结局

awaited

时间窗: June 2018

次要结局

  • Evaluation of course of Jaundice with the given intervention, demographic pattern of the pathology(june 2018)

研究者

发起方
Principal
申办方类型
Research institution and hospital

研究点 (1)

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