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临床试验/CTRI/2023/08/056463
CTRI/2023/08/056463尚未招募2 期

Clinical Study To Evaluate The Effect Of Yavaksharadi Yoga In Non-Alcoholic Fatty Liver Disease

PANKAJAKASTHURI AYURVEDA MEDICAL COLLEGE AND PG CENTRE1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年8月20日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
• Objective criteria –

研究概览

简要总结

Non-alcoholic fatty liver disease (NAFLD) is a broad term which describe the build-upof excessive fat in the liver cell, in the absence of alcohol intake (<20gm/day for women and<30 gm/day for men). In the majority of patients, NAFLD is commonly associated withmetabolic co-morbidities such as obesity, diabetes mellitus and dyslipidaemia. Yavaksharadiyoga which contains Yava kshara, Pippali, Vidalavana and Putika (Chiruvilwa) kashaya is one among the formulations mentioned in Yogaratnakara for Yakrit rogas. The drugs used mighthelpful in normalising the metabolic functions of liver. The present study is proposed to evaluate the effect of Yavaksharadi yoga in Non-alcoholic fatty liver disease.Study design will be clinical trial, done among 30 participants for a period of 45 days in the age group of 20-60 years. Participants diagnosed as per diagnostic criteria and satisfying the inclusion criteria will be selected conveniently from OPD and IPD of Pankajakasthuri Ayurveda Medical College and PG Centre. Subjects will be given the prepared medicine 500 mg morning 1 hour before food with Putika (Chiruvilwa) kashaya as Anupana for a period of30 days. Assessment of Objective criteria i.e., USG and LFT will be done before treatment and on 46th day, Assessment of subjective criteria like Appetite, Anorexia, Fatigue, Aching pain on right upper quadrant and Pedal oedema will be done before treatment,31st and 46th day. Nospecial diet modification or lifestyle change is advised during this period. The data will be analysed using the appropriate statistical tests.

Null hypothesis: Yavaksharadi yoga has no significant effect in Non-alcoholic fatty liver disease. Alternate hypothesis: Yavaksharadi yoga has a significant effect in Non-alcoholic fatty liver disease

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

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

入选标准

  • Subjects with Grade I & II Non- alcoholic fatty liver disease.
  • Age group-20-60 years.
  • Subjects will be selected irrespective of gender, caste, religion.
  • Subjects willing to sign informed consent.

排除标准

  • Non-Alcoholic fatty liver disease Grade III
  • Subjects with following drug intake – antiepileptic drugs, antituberculosis drugs, steroids, and heparin
  • Liver cirrhosis.
  • Kshara contraindicated patients
  • Known cases of Hepatitis B, Hepatitis C, Carcinoma of liver, Renal failure, Cardiac diseases and other systemic diseases.
  • Women who are Pregnant, planning to become pregnant during the study period, breastfeeding mothers.

结局指标

主要结局

• Objective criteria –

时间窗: Assessment of Objective criteria USG & LFT will be done before treatment & | on 46th day after treatment

LFT

时间窗: Assessment of Objective criteria USG & LFT will be done before treatment & | on 46th day after treatment

: Liver size

时间窗: Assessment of Objective criteria USG & LFT will be done before treatment & | on 46th day after treatment

: Grading of NAFLD

时间窗: Assessment of Objective criteria USG & LFT will be done before treatment & | on 46th day after treatment

-USG Abdomen to assess the following

时间窗: Assessment of Objective criteria USG & LFT will be done before treatment & | on 46th day after treatment

次要结局

  • • Subjective criteria(1) Appetite)

研究者

发起方
PANKAJAKASTHURI AYURVEDA MEDICAL COLLEGE AND PG CENTRE
申办方类型
Other [nil]

研究点 (1)

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