An Open clinical trial to evaluate the therapeutic effectiveness of selective Siddha Medicines - VeBSaM Therapy in the management of Cholelithiasis
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Reduction in the size of stone will be assessed by ultra sonogram before and after treatment
研究概览
简要总结
BACKGROUND: Siddha medicine is an ancient systems of medicine which contributes in treating the disease as well as plays an important role in revitalizing and rejuvenating the mind and body. Generally 4448 types of diseases are classified in the siddha system. This classification is mainly based on the derangement of 3 major humors, Vatham, Pitham and Kabam. Gall bladder (Pitha pai) is an organ which is existing in Pithasthanam in our body. Gallstone disease is caused by derangement of Pitham humor. Gallstones are formed from the constituents of the bile (cholesterol, bile pigments and calcium salts) along with other organic components. They are usually formed in gallbladder, but sometimes develop within extrahepatic biliary passages, and rarely in the larger intrahepatic bile duct. In India, the prevalence of gall stones is about 10-15% in adults[2]. The incidence of gall stones varies markedly in different geographic areas, age, gender, diet and various other risk factors. Gallstones are common in 4Fs acronym for – Fat, Female, Fertile(multipara) and Forty. Gallstone in one among the lifestyle related diseases caused by the recent change in the dietary pattern. There is an increased number of patients affected by Cholelithiasis, reporting at the OPD. This trial may provide alternate option for participants since surgery is the most suggested intervention in modern medicine. Most of the trial drug contains Hepatoprotective, hypolipidemic, antioxidant, Lithotriptic activity as mentioned in various research articles. Hence I had chosen this formulation “Vengara parpam, Bavana panjangula thailam, Santha Santhrothayam, Manjal noi kudineer†for the management of Cholelithiasis.
OBJECTIVE: To evaluate the therapeutic effectiveness of selective Siddha medicines - Vengara parpam, Bavana panjangula thailam, Santha Santhrothayam, Manjal noi kudineer in the management of Cholelithiasis by reduction in size of the stone will be measured.
METHODOLOGY: 20 diagnosed patients of Cholelithiasis within the age limit of 20-60 years willing to paticipate in the study by signing the consent form will be enrolled in the study based on the inclusion criteria and exclusion criteria.
OUTCOME: Reduction in size of stone will be assessed by using ultrasonogram before and after taking siddha treatment. Scoring Difference will be assessed in OTAGO Gallstones condition specific questionnaire in the cholelithiasis participants before and after taking siddha treatment.
RESULTS AND DISCUSSION: The results will be statistically analysed and reported.
KEYWORDS: Cholelithiasis, Pithapai kal, Vengara parpam, Bavana panjangula thailam, Santha Santhrothayam, Manjal noi kudineer.
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
- •1.Participants who were diagnosed Cholelithiasis by ultrasound scanning – size of the gallbladder stone between 3 to 10 mm.
排除标准
- •1.Participants with comorbidities like renal failure and liver cirrhosis 2.Pregnant and lactating mother.
- •3.Severe Cholecystitis, Choledocholithiasis, Acute and Chronic Pancreatitis.
- •4.Participants with Gallstone present in neck of gall bladder.
结局指标
主要结局
Reduction in the size of stone will be assessed by ultra sonogram before and after treatment
时间窗: 6 MONTHS
次要结局
- Scoring Difference will be assessed in OTAGO Gallstones condition specific questionnaire in cholelithiasis participants before and after taking siddha treatment(6 MONTHS)
研究者
Dr NISHA K J
National Institute of Siddha