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临床试验/CTRI/2024/09/073407
CTRI/2024/09/073407尚未招募3 期

A RANDOMIZED CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFECT OF SIMHASYADI GHANA VATI IN THE MANAGEMENT OF FUNCTIONAL DYSPEPSIA (AMLAPITTA)

Sindhana U1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年9月16日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Reduction of signs and symptoms of Functional dyspepsia

研究概览

简要总结

The classical reference of Amlapitta are from Kashyapa Samhita ,Yogaratnakaraand Bhava-prakasha and *Madhav Nidana,.*In Amlapitta the root cause is Agnimandya and formation of Aama .Treatment of Amlapitta  : Agnideepaka and Aamapachaka drugs are used .Tikta Rasapradhana drugs are commonly Aamapachaka & Agnideepaka acts on annavaha srotas. All diseases are caused by Mandagni (weak digestive fire), which negatively affects the samana and udana vayu, as both vayu are responsible for proper digestion.The excessive consumption of Amla (sour), Katu (spicy), Ushna (hot), and Viruddhashana (incompatible food combinations) can lead to an aggravation of Pitta dosha. Normally, Pitta has a Katu rasa (spicy taste), but when it is converted into Amla rasa (sour taste), it results in Amlapittam. Diagnosis is done based on Rome IV criteria.

Trial drug : Simhasyadi ghana vati told inChakradatta / Amlapitta adhikara.The ingredients are Vasa(Adatoda vasica ), Guduchi(Tinospora cardifolia ) and Brihati (Solanum indicum). It is indicated in Amlapitta,svasa,kasaand chardi expected to have effectiveness in Functional dyspepsia (Amlapitta). The mode of action of this yogam is Pittashamaka and Tridoshagna property due to its kashaya rasa , madura vipaka , laghu , snigha guna ,ushna veerya. It contains chemical constituents such as pyrroloquinazoline , glucosides which helps in healing the gastric mucosa.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Patient fullfilling the diagnostic criteria.
  • 2.Participants from whom the written consent is obtained.

排除标准

  • 1.K/C/O Peptic ulcer or any organic lesions and other systemic disorders.
  • 2.Patients under NSAID s ,antibiotics or other long term and continuous medications.
  • 3.History of Hematemesis.
  • 4.Unintentional weight loss 5kg within 6months.
  • 5.History of smoking and alcohol addiction.
  • 6.Symptoms such as recurrent vomitting,bleeding through rectum,malena,anemia,dysphagia.palpable mass per abdomen.
  • 7.Pregnant women and lactating mother.

结局指标

主要结局

Reduction of signs and symptoms of Functional dyspepsia

时间窗: Reduction of signs and symptoms of Functional dyspepsia within 4 weeks

次要结局

未报告次要终点

研究者

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

Sindhana U

Sri Jayendra Saraswathi Ayurveda College and Hospital

研究点 (1)

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