Clinical evaluation of Mustakarishta in the management of Grahani
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- To assess the clinical efficacy of Mustakarishta by the assessment of Changes in Ayurvedic Parameters of Grahani.
研究概览
简要总结
According to Ayurveda “RogaahSarvepi**mandagnou sudaramudarani cha†means all the diseasesare caused by mandagn**i ((digestive fire orvarious enzymatic process involved in digestion, absorption and metabolism atvarious level) which causes improper digestion of ingested nutrients (food)leading to formation or accumulation of Amadosha (intermediateproducts/or toxins) which produces its effect locally or generalized) .Grahani(middle part of amasaya and pakwasaya) is the place of Jatharagni.When the digestive power of Grahani become weaken due to the improper food habits and stressfull lifestyle, It causes Grahani roga which is also knownas Grahani in Ayurveda. In general, the digestion andabsorption of food materials can be divided into 3 major phases: Luminal,Mucosal and Post - absorptive phases. The luminal phase in which thefats, proteins, and carbohydrates are hydrolyzed and solubilized bysecreted digestive enzymes and bile can be considered to be the role of PachakaPitta which is responsible for the breakdown and synthesis of substances i.e.catabolic and anabolic activities. Mucosal phase relies on the integrity of thebrush-border membrane of intestinal epithelial cells to transport digestedproducts from the lumen into the cells is compared to Kledaka Kaphaby the virtue of its cooling propertywhich counter the heating property ofPitta. In modern medicine, the diseasecan be co-related with malabsorption syndrome and also Irritable BowelSyndrome. There are enormous formulations mentioned in Ayurvedic classics forthe augmentation and restoration of Agnibala in general and Grahaniin particular. The Mustakarishta is areputed formulation, mentioned in the Bhaishajya Ratnavali, aclassical text ofAyurveda forthe treatment of Ajirna,Agnimandya,Grahani, Visuchika etc.
As Grahani roga is caused due toagnimandya, the main line of treatment is to correct the agnidusti byadministering drugs which are deepana and pachana in nature. The trial drug Mustakarishta is a classical medicine mentioned in Bhaishajya Ratnavali as well as AFI- Part-I, 1:26(pg. 17) and API Part – II, Vol.II (1stedition, pg. 45). The Ingredients contain in this trial medicine are having properties like deepan, pachanaand sthambhaka and can able to correct the agnimandya condition anddisorders of Purishavaha s**rotas.
So the aim and object of the present study isplanned to evaluate therapeutic efficacy of Mustakarishtain thepatients of Grahani along with safety measures by observing adverseevents (AE) if any or Adverse drug reaction (ADR). The efficacy of the trialdrug would be assessed by observing the improvement in Subjective parameters(Clinical Symptoms). Improvement in WHOQOL score and lab. parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Known cases of Grahani (diagnostic criteria as per classical Ayurvedic parameters) Patients willing to give written informed consent to participate in the study.
排除标准
- •1.Patients with history of Inflammatory Bowel Disease (IBD), Koch’s abdomen, Gluten intolerance.
- •2.Patients with history of chronic Amoebiasis.
- •3.Known cases of Diabetes Mellitus.
- •4.Patients with poorly controlled Hypertension ( >160/100 mmHg) 5.Patients who have history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months 6.Symptomatic patients with clinical evidence of Heart failure 7.Known cases of malignancy 8.Patients with concurrent serious hepatic disorders (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT) > 2 times upper normal limit) or Renal Disorders (defined as S.
- •Creatinine >1.2mg/dL), Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease (COPD).
- •9.Women who are planning for conception / pregnant or lactating.
- •10.H/o hypersensitivity to any of the trial drugs or their ingredients 11.Patients who have completed participation in any other clinical trial during the past three months 12.Any other condition which the Investigator thinks may jeopardize the study.
结局指标
主要结局
To assess the clinical efficacy of Mustakarishta by the assessment of Changes in Ayurvedic Parameters of Grahani.
时间窗: Bseline,on 14th day, 28th day, 42th day, 56th day, 70th day,84th day,98th day
次要结局
- To assess the clinical efficacy of Mustakarishta by the assessment of Changes in IBS-QOL score.(Baseline,on 14th day, 28th day, 42th day, 56th day, 70th day,84th and 98th day)