An Open Labeled, Active Controlled, Randomized, Parallel Group Study Of Efficacy Of Nano Haritaki In Malavshtambha Vis-À-Vis Functional Constipation
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 1)To study the efficacy of Nano Haritaki in constipation by constipation assessment scale.
研究概览
简要总结
Functional constipation is a common gastrointestinal symptom with which patients are presented in clinics. A Rome III diagnostic criteria defines functional constipation as ‘A group of functional disorders which present as persistant difficult, infrequent, or incomplete defeacation. Available therapeutic options include stool softners, fibre suppliments, osmotic and stimulant laxatives. Prolonged use of laxatives may cause bloating, painful abdominal cramps, dehydration, diarrhoea, intestinal obstruction. Also various Rechak, Anulomak drugs are described in Ayurveda like *Haritaki (Terminalia chebula), Amlaki (Phyllanthus emblica), Manuka (Vitis vinifera), Falsa (Grewia asiatica) , Aragvadha (Cassia fistula).*These drugs have *Katu, Tikta Kashaya Rasa (pungent, bitter, astringent tastes)*which can cause unpleasantness, nausea, cardiac discomfort etc.
Nano Technology is an applied branch of basic science where particle size of drug is reduced to Nanometric scale (10-9). This increases bio-availability of drug, increases palatability and reduces exploitation of plants. Thus it is decided to study of efficacy of ayurvedic drug based on Nano Technology in functional constipation.
Diagnostic Criteria
It has been observed by various researchers that the prevalence of constipation differs when different criteria are used. Hence to bring uniformity in clinical trials and epidemiological studies across the world Rome criteria are used.
Rome III functional constipation Diagnostic criteria
- Must include two or more of the following:
a. Straining during at least 25% of defecations
b. Lumpy or hard stools in at least 25% of defecations
c. Sensation of incomplete evacuation for at least 25% of defecations
d. Sensation of anorectal obstruction/blockage for at least 25% of defecations
e. Manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor)
f. Fewer than three defecations per week
-
Loose stools are rarely present without the use of laxatives
-
Insufficient criteria for irritable bowel syndrome
CRITERIA FOR ASSESSMENT OF EFFICACY**:-**
1. Constipation Assessment Scale - at Baseline, 7th day and 14th day
2. Quality of Life- patients of constipation - at Baseline, 7th day and 14th day
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient having complaint Malavshtambha vis-a-vis functional constipation 2)Patient ready for the study and willing for treatment 3)Patient fulfilling Rome III criteria with symptoms Criteria fulfilled for the last 3 months with symptom onset at least 6 month prior to diagnosis.
排除标准
- •Pregnant and lactating women.
- •K/C/O uncontrolled Diabetes Mellitus, uncontrolled thyroid disorder, Renal failure, Anorectal disorders 3)Medication induced constipation eg.
- •Iron suppliments etc.
结局指标
主要结局
1)To study the efficacy of Nano Haritaki in constipation by constipation assessment scale.
时间窗: 1)at baseline, 7th day & 14th day. | 2)at baseline, 7th day & 14th day. | 3)at baseline, 7th day & 14th day.
2)To study the efficacy of Haritaki in constipation by constipation assessment scale.
时间窗: 1)at baseline, 7th day & 14th day. | 2)at baseline, 7th day & 14th day. | 3)at baseline, 7th day & 14th day.
3)To compare the efficacy of Nano Haritaki and Haritaki in constipation by constipation assessment scale.
时间窗: 1)at baseline, 7th day & 14th day. | 2)at baseline, 7th day & 14th day. | 3)at baseline, 7th day & 14th day.
次要结局
- 1)To study the effect of Nano Haritaki in constipation by assessing Quality of Life – patients of constipation questionnaire.(2)To study the effect of Haritaki in constipation by assessing Quality of Life – patients of constipation questionnaire.)