Integrated Management of Metabolic Dysfunction Associated Steatotic Liver Disease Incorporating Traditional Medicine: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 82
- 试验地点
- 1
研究概览
简要总结
Participant Recruitment- MASLD cases will be enrolled with documented diagnosis of MASLD from gastroenterology OPD of Sir Sunderlal Hospital, IMS BHU Varanasi. Patient will be scrutinized to make sure that they meet all the inclusion criteria and none of the exclusion criteria.
Written and informed consent will be taken from the patients, explaining about purpose of the study, details of treatment involved, potential risks and benefits, confidentiality, and the right to withdraw anytime without penalty.
These patients will undergo (if not already done), various blood investigations such as:
1.CBC
2.LFT
3.RFT
4.RBS
5.Lipid Profile
6.USG & Fibro scan
**Randomization:**Included patients will be allocated randomly through computer generated randomisation schedule in group A and group B.
Group A: Intervention group Ayurvedic Regimen i.e Kalmegh 2gm in two divided dose and Amalaki (amla) 2gm in two divided will be given, along with this standard treatment and life style and diet modification will be given.
Group B: Control Group (Standard treatment therapy+ Lifestyle Modification)
Follow up: Patients will be followed for 6 months i.e 2,4,6 months. After 4th month drug intervention will be stopped and then patients will be followed for next 2 more months in order to see the reversal /non reversal of disease i.e response of body after stooping the drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 59.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient giving consent to participate in the study.
- •Patient of age between 18-59 years.
- •Patient attending the OPD of SS HOSPITAL, IMS, BHU Varanasi.
- •Patients diagnosed with simple fatty liver based on imaging assessment.
- •Patients diagnosed with MASH or MASH with fibrosis of stage 1, stage 2 and stage 3.
排除标准
- •Patient with significant levels of alcohol consumption.
- •Patients with liver cirrhosis.
- •Patients with any other chronic severe illness.
- •Patients on treatment with other ayurvedic regimens.
- •Patients not giving consent to participate in the study.
研究者
Dr Sunil Kumar
Institute of Medical Science