Single arm clinical study to evaluate efficacy of Mustakadi Churna in the management of Grahani with special reference to Irritable Bowel Syndrome in the children of Age 8to 16 Yrs
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Dr Swapnil Devkate
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To study efficacy of Mustakadi churna in grahani roga.
概览
简要总结
Childhood is a period In which growth and development are at their
peak.Normally in this period leads to proper growth and development and factors
affecting during this period will not only hamper growth of the child but also it’s
physical activities , social behaviour and immunity concentration.
The Disease “Grahani Dosha” is the leading disorder of gastrointestinal tract.
According to Charaka Aharya ,Grahani is the seat of agni. It is not only seat of
agni but also supported and strengthened by it (i.e. Jatharagni). The term Grahani
dosha implies the malfunctioning of agni. The agni is primarily located in Grahani
(duodenum including upper small part of small intestine). It receives the food (i.e.
Grahan), retains food (i.e. Dharan), till Pachan of ahar (i.e. digestion). While explaining Grahani Dosha, he said that three out of four types of Agnis i.e.Teekshna, Manda,Vishama- may cause Grahani dosha. And if not treated timely then Grahani Roga ensues.Acharya Sushruta has mentioned that, patients of Atisara, during the stage of
Agnimandya, if indulge in injudicious diet, may lead to Grahani Roga. Thus any
disturbance in the functioning of Grahani results in symptoms of indigestion and
is symbolized as Grahani Dosha.
The lakshana of Grahani roga like udarshool, kshudhaalpata, adhman,
vibandha, abaddhamala pravrutti, shleshmala pravruti, durgandha malapravrutti, balakshaya etc.
According to Modern Science, Irritable bowel syndrome (IBS) is a group of symptoms that occur together, including repeated pain in your abdomen and changes in your bowel movements, which may be diarrhea, constipation, or both.
With IBS, you have these symptoms without any visible signs of damage or disease in your digestive tract
Primary Objective
To study efficacy of Mustakadi churna in grahani roga.
Secondary objective:
To study the concept of grahani roga in children
To study the etiopathogenesis of Grahani roga related to disease from modern point of view in children.
Study design - Single arm study.
Study setting- patient will be selected randomly from OPD of kaumarbhritya department in our hospital.
Duration of study-18 months.
Duration of treatment-45days
Sampling method - simple random sampling method
Eligibility criteria:
Inclusion criteria -
Patient in age group of 8 to 16 years will be selected irrespective of sex, socioeconomic status and Religion.
Patient suffering from Grahani dosha, symptoms like udarshoola, kshudha alpata, abaddha malpravritti.
Exclusion criteria-
Children below 8 yrs and above16 yrs.
Children suffering from chronic gastrointestinal disorder And acute infectious diseases.
Children suffering from the congenital anomalies.
Children with any psychological disorder or any another treatment.
Withdrawal criteria- Patient will be withdrawl from study if-
Children not on regular follow up.
If any other life threatening symptoms occurs.
Patient or their relative willing to discontinue during treatment.
Diagnostic Criteria-
Patient will be diagnosed on the basis of clinical signs and symptoms of Grahani with respective grading.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 8.00 Year(s) 至 16.00 Year(s)(—)
- 性别
- All
入选标准
- •Patient in age group of 8 to 16 years will be selected irrespective of sex, socioeconomic status and Religion.
- •Patient suffering from Grahani dosha, symptoms like udarshoola, kshudha alpata, abaddha malpravritti.
排除标准
- •Children below 8 yrs and above16 yrs.
- •Children suffering from chronic gastrointestinal disorder And acute infectiou diseases.
- •Children suffering from the congenital anomalies.
- •Children with any psychological disorder or any another treatment.
结局指标
主要结局
To study efficacy of Mustakadi churna in grahani roga.
时间窗: 45 day
次要结局
- To study the concept of grahani roga in children(To study the etiopathogenesis of Grahani roga related to disease from modern point of view in children.)
研究者
Dr swapnil devkate
LRP Ayurvedic Medical College and Hospital