An Analytical & Clinical Study to evaluate the effect of Amladhya Loham in Amlapitta (Dyspepsia) - An open labelled single arm study
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To assess analytical properties & evaluate the therapeutic effects of Amladhya Loham in managing symptoms of Amlapitta (Dyspepsia).
研究概览
简要总结
Amlapitta (Dyspepsia) being one of the Annavaha Strotas Dushti Vikara is a commonest disease in present era. The pooled prevalence of dyspepsia in India is estimated to be between 7.6% to 49% of the population with prevalence rate more in males in the age group of 35-501. The risk factors were age, irregular food habits, tea/coffee intake, tobacco, and alcohol consumption.2 Dyspepsia encompasses symptoms such as upper abdominal fullness, heartburn, nausea, belching, and upper abdominal pain, often occurring after eating or drinking. Although typically not life-threatening, these symptoms can significantly impact an individual’s quality of life. Prolonged reliance on antacids can have detrimental effects, leading to constipation and potentially serious complications like neurotoxicity over time. If left untreated, dyspepsia can lead to serious complications making treatment more challenging.
According to Ayurveda Mandagni (weak digestive fire), which negatively affects the Samana and Udana Vayu, as both Vayu are responsible for proper digestion. The excessive consumption of Amla (sour), Katu (spicy), Ushna (hot), and Viruddhashana (incompatible food combinations) leads to an aggravation of Pitta Dosha & gets convertedinto Amla Rasa (sour taste), resulting in Amlapitta.3,4
Considering its severity & serious complications; a combination of herbo-mineral cost-effective formulation i.e. Amladhya Loham mentioned in Rasendra Chintamani under Amlapitta Adhikara**5 which has been said as Maha Amlapitta Nashaka is taken for study. The key ingredients, Amlaki has anti-spasmodic, anti-ulcer actions6*, Pippali* corrects the Apakva Pitta & has Vatanulomana action7*, Loham Bhasma* reduces acidic secretions, improves bowel movement8*,* and Sharkara Churna is Ruchya & also has properties like Daha Hrut, *Vata Pittahara9,*work synergistically to alleviate Pitta Dosha, correct Agni, and aid in Shamana of Amlapitta (Dyspepsia).
To check the authenticity of the formulationfor its further broader usage in the market analytical study is planned.
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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Classical Symptoms of Amlapitta
- •Aruchi (anorexia)
- •Gurukoshthatva (heaviness in abdomen)
- •Gaurav (lethargy)
- •Vibandh (Constipation)
- •Shiroruja (Headache)
- •Utklesh (Nausea)
- •Tiktamlodgar (Acid eructation)
- •Klama (exhaustion) and
- •Hrid- Kanta Daha (heartburn) will be considered for the study and examined on the basis of Dosha Dushya etc with a help of a special proforma after having a written consent.
- •Rome IV diagnostic criteria for Dyspepsia (Patients presenting with recurrent upper GI symptoms suggestive of dyspepsia for at least the past 6 months) One or more of the following:
- •Bothersome postprandial fullness
- •Bothersome early satiation
- •Bothersome epigastric pain
- •Patients with any of the following features will be evaluated clinically for other diagnoses with dyspepsia and will be ruled out (No evidence of systemic metabolic structural disease that is likely to explain the symptoms)
- •Signs or symptoms of GI bleeding.
- •Unintentional weight loss.
- •Palpable abdominal mass or lymphadenopathy on exam.
- •Family history of gastric cancer and no recent upper endoscopy.
- •Persistent vomiting.
排除标准
- •ï± Age below 18 above 60 years ï± Volunteers with evidence of malignancy ï± Suffering from major Systemic diseases ï± Metabolic diseases other than Dyspepsia ï± Chronic diseases with long run of medications ï± Pregnant ladies & lactating women ï± Participants currently taking medications or supplements that may affect the present study ï± Participants currently enrolled in any other clinical trials or having participated in any other clinical trial in the past 30 days.
- •ï± Participants with history or currently under substance abuse.
- •ï± Any other conditions which investigator things may jeopardize the study.
结局指标
主要结局
To assess analytical properties & evaluate the therapeutic effects of Amladhya Loham in managing symptoms of Amlapitta (Dyspepsia).
时间窗: 0 day and 31st day
次要结局
- 1. To prepare Amladhya Loham(2. Evaluate the safety of Amladhya Loham)
研究者
Punya R Gangadkar
Sushrutha Ayurvedic Medical College and Hospital