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临床试验/CTRI/2024/08/072611
CTRI/2024/08/072611尚未招募2/3 期

Effectiveness of Vaishwanara Choornam and Drakshadi Kashayam aqueous extract in Non-Alcoholic Fatty Liver Disease

NIDHISH NAIR1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年8月19日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
Reduction in grades of fatty liver as identified by echogenicity of liver through USG abdomen.

研究概览

简要总结

Non-alcoholic fatty liver disease (NAFLD) has a global prevalence of 25% and is a leading cause of cirrhosis and hepatocellular carcinoma. NAFLD encompasses a disease continuum from steatosis with or without mild inflammation (non-alcoholic fatty liver), to non-alcoholic steatohepatitis (NASH), which is characterized by necroinflammation and faster fibrosis progression, NAFLD has a bidirectional association with components of the metabolic syndrome, and type 2 diabetes increases the risk of cirrhosis and related complications

NAFLD may be corelated with Satarpana janya vyadhis due to intake of nidanas there is resultant agnimandyam causing ama formation and vitiation of Kapha and medas leading to accumulation in Yakrith which is Pittasthana as the disease advances it can result in Dhatupaka (necroinflammation) NASH , the final phase of the disease is characterized by increase of Vata Gunas resulting in fibrosis & cirrhosis.Hence the medicines selected should possess the qualities like deepana,pachana, srothosodhana,vatanulomana and yakruthprasadana.

The study drug Vaishwanara choornam,and Drakshadi Kashyam mentioned in Ashtang Hrudya gulma chikitsa and jwara chikitsa respectively ,the formulation will be prepared  according to the methods adopted from classical Ayurvedic textbooks for choornam and in dose adjusted Kashaya aqueous extract form with date of administration labelled in it for 60 days. An interventional pre – post study in a single group will be conducted in participants attending OPD of Department of Kayachikitsa at Government Ayurveda College, Thiruvananthapuram. Participants will be  advised to take  Vaishwanara Choornam in dose of 6g with Drakshadi Kashyam administered as whole Kashaya aqueous extract at a dose of 3gm (1 sachet) with 96 ml lukewarm water twice daily at 6AM,6PM for a period of 60 days. A total of 120 kashaya aqueous extract sachet and 120 packets of vaishwanara choornam, 30 packets of aqueous extract of kashayam  and 30 packets of choornam  will be  given to the participants in each visit at an interval of 15days.After collecting baseline data participant will be evaluated  on the 0th and 61st day. USG, Scoring and Blood parameters are done before and after the study. The results obtained will be statistically analyzed and concluded.

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
25.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Male and Female participants of age group between 25-65 years of age having Grade 1 and Grade 2 Non-Alcoholic Fatty Liver Disease diagnosed through ultrasonography.

排除标准

  • Known history of any serious systemic illnesses.
  • Pregnant and lactating women.

结局指标

主要结局

Reduction in grades of fatty liver as identified by echogenicity of liver through USG abdomen.

时间窗: 60 days

次要结局

  • Reduction in Elevated Liver Enzymes.(Reduction in NAFLD Fibrosis Score.)

研究者

发起方
NIDHISH NAIR
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Nidhish Nair

Government Ayurveda Medical College and Hospital, Thiruvananthapuram

研究点 (1)

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