To Study The Efficacy Of Marichadi Choorna in Comparision with Dadimashtaka Choorna In Grahani Roga: A Controlled Randomized Clinical Study
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To assess the efficacy of Marichadi choorna with Dadimashtaka choorna based on improvements in IBS severity score and lakshanas in patients diagnosed with Grahani
研究概览
简要总结
Management of Grahani roga in adults of age group 20-60 years for a period of 30 days. During this study period 30 subjects diagnosed with Grahani roga will be recruited and divided into two groups. Group A ( Trial drug/ Intervention group). It includes 15 subjects qualifying inclusion criteria of the current study will be administered Marichadi choorna internally in the dose of 6 grams twice daily in between meals with takra and guda as anupana for 30 days starting from day-01 of trial, assessment of the patient during trial on 0th day(baseline), 15th day, 30th day and after trial on 45th day. Group B (Control drug/ Comparator group) it includes 15 subjects qualifying inclusion criteria of the current study will be administered Dadimashtaka choorna internally in the dose of 6 grams twice daily in between meals with takra for 30 days starting from day-01 of trial, assessment of the patient during trial on 0th day(baseline), 15th day, 30th day and after trial on 45th day. The primary outcome measure will be significant improvements in IBS severity score and lakshanas in patients diagnosed with Grahani roga after 30 days. The secondary outcome measure will be improvement noticed in signs and symptoms by assessing the IBS related quality of life questionnaires in patients diagnosed with Grahani roga after 30 days. Statistical analysis will be done through data obtained based on, before and after treatment assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Subjects with classical lakshana of grahani 1 Muhur baddha Muhur drava mala pravritthi (Altered bowel habit) 2 Udara shoola (Abdominal pain) 3 Tikta amlodgara (Dyspepsia) 4 Adhmana (Abdominal distention) 5 Arochaka (Anorexia) 6 Bala kshaya (loss of strength) Rome’s 4 criteria for diagnosis of IBS Recurrent abdominal pain on average at least 1 day per week in the last 3 months associated with 02 or more of the following criteria: 1 Related to defecation 2 Associated with a change in frequency of stool 3 Associated with a change in form(appearance) of stool Subjects with either sex irrespective of religion within the age group of 20-60years.
排除标准
- •Subjects suffering from systemic disorders like uncontrolled diabetes mellitus uncontrolled hypertension Subjects suffering from infective diarrhoea, Lactose intolerance, Other GI disorders except dyspepsia.
- •Subjects who are pregnant, lactating women.
结局指标
主要结局
To assess the efficacy of Marichadi choorna with Dadimashtaka choorna based on improvements in IBS severity score and lakshanas in patients diagnosed with Grahani
时间窗: 0th day(Baseline), 15th day, 30th day and 45th day
次要结局
- To assess the efficacy of Marichadi choorna with Dadimashtaka choorna in improvements of signs and symptoms by assessing the IBS related quality of life questionnaires in patients diagnosed with Grahani roga.(0th Day(Baseline), 15th day, 30th day and 45th day)
研究者
Dr Sameeksha N Ariga
Shri Dharmasthala Manjunatheshwara Institute Of Ayurveda and Hospital, Bengaluru