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临床试验/CTRI/2026/02/105027
CTRI/2026/02/105027尚未招募2/3 期

ADD-ON EFFECT OF DRAKSHARISTA TO THIAMINE IN THE MANAGEMENT OF ALCOHOL USE DISORDER-A RANDOMIZED DOUBLE BLIND CONTROLLED STUDY

Dr RajimunnisaBegam Shaik1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年4月1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
40
试验地点
1
主要终点
AUDIT SCALE, Liver parameters like Liver Function Test and the gamma-glutamyl-transferase test in Alcohol Use Disorder.

研究概览

简要总结

As per Ayurvedic texts, the disease caused by the abuse of alcohol is called Madatyaya, which presents with clinical features similar to alcoholism. Madatyaya is a Tridoshaj disorder with Vataj, Pitta, Kapha, and Sannipataj types. Treatment typically begins at the site of Kapha, as it is predominantly affected, along with Pitta and Vata.

Alcohol Use Disorder (AUD) is characterized by a strong internal drive to consume alcohol, impaired control over use, prioritization of alcohol over other activities, and persistence despite harmful consequences. People with AUD are at increased risk of liver cirrhosis, pancreatic disease, and accidents. Globally and in India, AUD contributes significantly to morbidity and mortality, with a large proportion of affected individuals requiring treatment.

Excessive alcohol consumption directly affects the Hriday, impacting both physical and psychological health through the Rasavaha and Manovaha Srotas. Conventional management of AUD ranges from psychotherapy to pharmacological interventions, but these drugs often have contraindications, and a universally effective treatment is lacking.

Ayurvedic therapies have shown protective effects on alcohol dependence, withdrawal anxiety, and liver health, acting as hepatoprotective and antioxidant agents. In Ayurveda, Madatyaya involves vitiation of both Shareerika and Manasika Doshas, affecting physical, psychological, social, and occupational well-being. Management primarily includes Doshavsechana, Rasayana, and Satvavajaya Chikitsa. Preparations like Karjuradhi Mantha have Rasayana and Ojovardhana properties, while Virechana aids in Dosha elimination, pitta reduction, and gut microbiota improvement.

The present study has been designed to evaluate an integrative Ayurvedic treatment protocol, including Satvavajaya Chikitsa, pathya-apathya, and a Yoga regimen, for the management of Madatyaya (alcohol dependence).

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

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

入选标准

  • Patients of age group 20-50 years Patients clinically diagnosed on the basis of Samanaya Madatyaya Lakshanas and on the basis of Criteria of Alcohol Use Disorder according to DSM-V ICD-11(Code 6C40 Z) Patients will be selected randomly irrespective of gender economical educational and marital status Patients who are willing to provide written informed consent with desire to stop the alcohol abuse.

排除标准

  • Patients with severe Alcohol Use Disorder as per AUDIT scoring more than 31 Highly violent patients and Patients suffering from major psychiatric illnesses like Major depressive disorder Schizophrenia Psychosis and Epileptic disorders Patients with any kind of major systemic illness such as Malignancy Diabetes CVD HIV TB etc Patients withLiver failure Liver Cirrhosis Hepatic necrosis Hepatitis Cerebral degeneration Pregnant ladies and lactating mothers.

结局指标

主要结局

AUDIT SCALE, Liver parameters like Liver Function Test and the gamma-glutamyl-transferase test in Alcohol Use Disorder.

时间窗: Baseline,4 weeks, and 8 weeks

To evaluate the add-on effect of Mahakalyanaka vati capsules on Sleep, Cognition, depression, and side effect profile of Alcohol use Disorder by ISI, MoCA, HAM-D, UKU side effects rating scale.

时间窗: Baseline,4 weeks, and 8 weeks

次要结局

  • To evaluate the add-on effect of Mahakalyanaka vati capsules on WHOQOL-BREF

研究者

发起方
Dr RajimunnisaBegam Shaik
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr RajimunnisaBegam Shaik

KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya and Medical Research Centre, Belagavi

研究点 (1)

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