跳至主要内容
临床试验/CTRI/2024/11/077204
CTRI/2024/11/077204尚未招募2 期

A randomized comparative trial with Rakta Prasadak Ausadha in Yakrita Dushti for validation of Garbhasya yakratpleehano shonitajo

National Institute of Ayurveda1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年12月1日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
60
试验地点
1
主要终点
CLASSICAL SIGN AND SYMPTOMS OF YAKRITA DUSHTI AS PER SAMHITA

研究概览

简要总结

Purpose of study:

Liver disease accounts for 2 million deaths annually(cirrhosis, viral hepatitis, and liver cancer) and is responsible for 4% of all deaths (1 out of every 25 deaths worldwide); approximately two-thirds of all liver related deaths occur in men & 1 out of 3 liver-related deaths occur among females Within this estimate, liver cancer accounts for 600,000 to 900,000 deaths.

1 Currently liver disease is the eleventh-leading cause of death, but liver deaths may be underestimated.

2 Liver disease is fast spreading like an epidemic in India with one out of every five adults getting affected. Liver related deaths in India have reached a staggering figure of 268,580 (3.17% of all deaths) per year contributing to 18.3% of global liver-related deaths that account over 2 million deaths globally per year.

3 There are more than a hundred different liver diseases of diverse nature that are being identified as the leading causes of disability, disease, and death globally. ï‚— Liver diseases are broadly caused by hepatitis viruses (A to E), alcohol, non-alcoholic fatty liver disease (NAFLD), drugs, autoimmune and genetic diseases, cryptogenic and liver tumors-benign and malignant. ï‚— Liver deaths occur predominantly because of liver cirrhosis, acute liver failure, and liver cancer In Ayurveda, much attention has been given to Anga-Avayava Utpatti in Garbha Avakranti Sharira4. Garbha Avakranti refers to the growth of the Garbha in Garbhavastha. The discipline of medicine known as embryology studies the formation of the human embryo and its development inside the uterus until the delivery of a child. Different opinion exists regarding Anga-Avayava Utpatti by various Acharya. Acharya Sushruta, while describing the formation of organs in the foetus, has mentioned that the Yakrita (liver), Pleeha (spleen) are developed from Shonita.5 In Kashyap Samhita, it has been mentioned that during Anga- Avayava Utpatti (development of different organs in fetus) Hardiya is formed from Shonita, Yakrita from Hardiya, Pleeha is formed from Yakrita, and from Pleeha Fuffus is formed. As per Samhitas, Shonita is involved in development of different Anga- Avayava. We has observed that in particular diseases like Pandu (anaemia), Pleeharoga (splenomegaly), Twak Vikara (skin disorder), Kamala (jaundice), etc, Yakrita and Pleeha are affected where Shonita is the common factor. Some studies have been done & it has been observed that Shonita is a common factor in the diagnosis and treatment of diseases. Some drugs like Lauha Bhasma, Tamra Bhasma, Manjistha, Shatavari, and Punarnava, which are used for Shonita, can be beneficial for the diseases of Yakrita, and Pleeha.6 During the treatment of the Yakrita dushti (liver disorders), we mainly focus on those drugs which are mentioned under the heading of Yakrita Rogadhikar. We always ignore the concept of embryogenesis i.e. Shonita is responsible for the formation of Yakrita. This study mainly focuses on that concept & seeks to know the effect of Rakta Prashadhak Aushodha on Yakrita dushti.

NEED TO STUDY

  1. There is a need to explore the fundamental principles related to Anga-Avyava Utpatti under the lens of clinical utility.

  2. The Samhita principles of embryogenesis need to be re-validated and established.

  3. The prevalence of morbidity & mortality of liver diseases is currently very high and there is a lack of effective treatment for curing the disorder so there is a need to discover new drugs & concept of treatment.

  4. There is a need to focus on the concept of Rakta Prashadhan in liver disorders as we mainly follow the treatment concept of Yakrita dushti, that focus on drugs those are mentioned under Yakrita Rogadhikar.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Patient with already known case of any liver disorders (pre-hepatic and hepatic cause) with deranged LFT (liver function test) values falling in the range.
  • Patient of either sex having age between of 18 to 50 yrs.
  • Patients who are willing to sign consent form for the trial.

排除标准

  • Patients below age of 18 yrs and above 50 yrs.
  • ii.Patient with k/c/o uncontrolled Diabetes, Hypertension, Carcinoma, etc.
  • Patients with post hepatic conditions such as common bile duct obstruction, liver cirrhosis, bile duct tumor, carcinoma of pancreas head, etc.
  • Patient participated in any clinical trial with in last six months.
  • Pregnant or lactating women.

结局指标

主要结局

CLASSICAL SIGN AND SYMPTOMS OF YAKRITA DUSHTI AS PER SAMHITA

时间窗: after 4week

次要结局

  • Based upon the changes in liver function test, CBC, TEC(15 days)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr. Ritika

National Institute of Ayurveda

研究点 (1)

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