An Open Label Single Arm Clinical Trial to evaluate the effectiveness of Siddha formulations in the management of Kalleeral Noi(Alcoholic Liver Disease) among Out Patients attending Ayothidoss Pandithar Hospital
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The Therapeutic effectiveness of Siddha formulations will be evaluated by observing improvement in clinical signs and symptoms after treatment.
研究概览
简要总结
BACKGROUND :
Alcohol is a direct hepatotoxin, and its ingestion causes the initiation of numerous metabolic responses that influence the final Hepatotoxic response. Alcoholic Liver Disease (ALD) is one of the deadliest diseases that impacts about 5.3% of Global deaths, especially in men with a high death rate and a Global burden of 5.1%. Current management of Alcoholic Liver Disease includes steroidal medication, Nutritional supplements, and abstinence from alcohol. These drugs develop resistance and troublesome side effects in patients. The rationale behind this study is to mitigate the symptoms of ALD using the Siddha formulation.
AIM:
To evaluate the clinical effectiveness of Siddha formulations Thaalisathi Chooranam andVediannabethi Chenduram in the management of Kalleeral Noi (Alcoholic Liver Disease) at early stages among patients reporting at Ayothidoss Pandithar Hospital.
OBJECTIVES :
PRIMARY OBJECTIVE :
To evaluate the clinical effectiveness of Siddha formulations by observing changes in signs and symptoms of the patient before and after treatment.
SECONDARY OBJECTIVE :
- To evaluate the changes in MDF score ,Lab parametes - LFT (Serum Bilirubin, AST, ALT, ALP, GGT) and Lipid profile before and after treatment.
- To evaluate the changes in Liver function by comparing the MELD score ( Serum Total Bilirubin, Serum Creatinine and INR ratio) before and after treatment.
- To ensure patient safety by monitoring Liver Function Test ( LFT),Renal Function Test (RFT) and Hematological parameters before and after treatment.
STUDY DESIGN : An open-Label single arm Clinical Trial
INTERVENTIONAL DRUGS :
I)Thaalisathi Chooranam :
Dosage : 2 grams
Regimen : BD (Twice in a day ),after food
Adjuvant : Honey
II) Vediannabethi Chenduram :
Dosage : 130 mg
**Regimen:**BD (Twice in a day ),after food
**Adjuvant :**Honey
TREATMENT PERIOD : 40 days
EXPECTED OUTCOME :
- The therapeutic effectiveness of Siddha formulations will be evaluated by observing the improvement in clinical signs and symptoms after treatment.
SECONDARY OUTCOME :
- Monitoring the changes in the MDF score and MELD score, Lab parameters ( LFT - Serum Bilirubin,AST,ALT,ALP,GGT), and Lipid profile with its permissible limit after treatment.
- The safety of the trial drugs will be ensured by observing the changes in Haematological parameters and lipid and Renal function markers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •History of Alcoholic Abuse for more than five years and the Alcoholic dependency will be confirmed by AUDIT questionnaire Subjects who are willing to quit Alcohol Participants with clinical signs and symptoms of early stages of Alcoholic Liver Disease that confirmed with USG.
- •Individuals with elevated Liver enzymes Total bilirubin Direct and Indirect Bilirubin levels such as AST,ALT,ALP, GGT and lipid profile Patients with an MDF score of less than 32.
排除标准
- •Individuals with advanced stages of Alcoholic liver disease with MELD score of greater than 20 Withdrawal symptoms like seizure , Alcohol Withdrawal Delirium and Alcohol Hallucinosis Substance abuse other than alcohol like Narcotics Pregnant and Lactating women participants with known liver diseases such as inherited metabolic causes Hemochromatosis Wilsons disease Hepatic infection and hepatic carcinoma.
结局指标
主要结局
The Therapeutic effectiveness of Siddha formulations will be evaluated by observing improvement in clinical signs and symptoms after treatment.
时间窗: Screening Period: 2 Months | Trial period: 14 months | Assessment Period:2 Months.
次要结局
- Monitoring the changes in the MDF score & MELD SCORE, Lab parameters including LFT (Serum Bilirubin, AST, ALT, ALP, GGT), & lipid profile with its permissible limit after treatment.(Observing the changes in hematological, liver, & renal functional markers will ensure the safety of the trial drugs.)
研究者
Dr. J.Jinavani
National Institute of Siddha