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临床试验/CTRI/2024/12/078386
CTRI/2024/12/078386尚未招募不适用

Assessment of Ekdoshaj types of Madatyaya Lakshanas in Chronic Alcoholic Person with special reference to Serum Gamma Glutamyl Transferase test

Not Applicable1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
To assess and compare the Single cause types of Alcoholism Symptoms in chronic

研究概览

简要总结

  1. Title

Assessment of Ekdoshaj types of Madatyaya Lakshanas in Chronic Alcoholic Person with special reference to Serum Gamma Glutamyl Transferase test.

2.Objectives

.PRIMARY OBJECTIVE:

To assess and compare the Ekdoshaj types of Madatyaya Lakshanas in chronic alcoholic person with special reference to Serum Gamma Glutamyl Transferase test.

3.Methodology

  1. APPROPRIATE STUDY DESIGN: It is an Observational study

STUDY SETTING: The proposed study will be done in 3 levels.

LEVEL 1 (Conceptual) – Ayurvedic literature regarding Madatyaya and its prakara, lakshanas and modern concept of Chronic Alcoholism & Serum GGT level will be studied.

LEVEL 2 (Observational)- Assessment of Ekdoshaj types of Madatyaya lakshanas i chroic alcoholic persons and level of Serum GGT level will be done.

LEVEL 3 (Analysis) – Analysis of generated data will be performed as Qualitative and Quantitative data for result

3.Study place: OPD and IPD of Institutional Hospitals and nearby Hospitals of PCMC area.

4.Study Duration: 18 Months

5.Study Population: Diagnosed Madatyaya Person fulfilling all inclusion criteria.

6.Sample size: • 4(pq)/d2 • P- prevalence rate i.e 9.4%=0.094 • q= 1-p=1-0.094=0.906 • Allowable error -10% d=0.1 • Sample size=4(pq)/d square =4(0.094*0.906)/0.1*0.1 40 persons will be taken for the study.

7.Sampling technique: Purposive sampling technique will be taken.

8.Method of selection of study subject:

A) Inclusion Criteria:

1)Male Persons of Age Group of 20 To 50 Years.

  1. Person consuming Madya from 3 to 10 years.

  2. Person consuming more than 4 drinks on any day or more than 14 drinks per week. Criteria as per National Institute on Alcohol, Abuse and Alcoholism (NIAAA).

B)Exclusion Criteria:

1)Known cases of cholestasis will be excluded.

2)Known cases of Dengue fever, Pyrexia of unknown origin, Systemic lupus erythematosus, Disseminated intravascular coagulation will be excluded.

3)Known cases of Pancreatitis, Malignancy will be excluded. 4) Patients with organ failure will be excluded.

研究设计

研究类型
Observational

入排标准

年龄范围
20.00 Year(s) 至 50.00 Year(s)(—)
性别
Male

入选标准

  • Male Persons of Age Group of 20 To 50 Years.
  • Person consuming Madya from 3 to 10 years.
  • Person consuming more than 4 drinks on any day or more than 14 drinks per week.
  • Criteria as per National Institute on Alcohol, Abuse and Alcoholism (NIAAA).

排除标准

  • Known cases of cholestasis will be excluded.
  • Known cases of Dengue fever, Pyrexia of unknown origin, Systemic lupus erythematosus, Disseminated intravascular coagulation will be excluded.
  • Known cases of Pancreatitis, Malignancy will be excluded.
  • Patients with organ failure will be excluded.

结局指标

主要结局

To assess and compare the Single cause types of Alcoholism Symptoms in chronic

时间窗: 10 Months

alcoholic person with special reference to Serum Gamma Glutamyl Transferase

时间窗: 10 Months

test

时间窗: 10 Months

次要结局

  • NA(NA)

研究者

发起方
Not Applicable
申办方类型
Other []
责任方
Principal Investigator
主要研究者

Vd Nituja Sanjay Ethape

Department of Rognidan Avum Vikriti vigyana

研究点 (1)

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