A Clinical study to evaluate efficacy and safety of CaFi Tablets (Cassia Fistula Extract) in the Management of Functional Constipation and Irregular Bowel Habit in Geriatric Population - An Open Labeled, Randomized, Comparative, Multi centric, Interventional, Prospective, Clinical Study.
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in frequency of bowel movements
研究概览
简要总结
It is a clinical study to evaluate efficacy and safety of CaFi Tablets (Cassia Fistula Extract) in the Management of Functional Constipation and Irregular Bowel Habit in Geriatric Population - An Open Labeled, Randomized, Comparative, Multi centric, Interventional, Prospective, Clinical Study. The study will be conducted in 2 to 3 centres in India. As per computer generated randomization list, subjects will be randomized either to CaFi tablet group or Senna extract tablet group in 1:1 ratio. Subjects in CaFi tablet group will be given one Tablet of 250 mg of CaFi at bedtime with water for 14 days. Subjects in Senna tablet group will be given one Tablet of 250 mg of Senna at bedtime with water for 14 days. All the subjects will be asked to stop given medication after 14 days and will be followed for next seven days to observe recurrence of symptoms of functional constipation and irregular bowel habit. The primary objective of the study will be to assess change in frequency of bowel movements. The secondary objectives of the study will be to assess change in stool form using graded scale, changes in symptoms of functional constipation including straining on defecation, sensation of incomplete evacuation, sensation of ano-rectal blockage, manual manoeuvres required & average time spent for bowel evacuation, changes in associated clinical symptoms including headache, belching, flatulence, abdominal distension, bloating, acidity on graded scale, global assessment of overall change as per the investigator and subject, tolerability of study product as per the investigator and subject by assessing Adverse Events, Adverse Reactions, and laboratory investigations such as Blood sugar fasting, Liver profile (SGOT, SGPT, Sr. Bilirubin) and Renal Profile (Sr. Creatinine) on screening visit, baseline visit, day 7, day 14 and day 21
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
- 60.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects presenting with two or more of the following for the last 3 months with symptom onset at least 6 months prior to diagnosis: a).
- •Straining during more than one fourth (25 percent) of defecations b).
- •Lumpy or hard stools (Bristol Stool Form Scale 1-2) more than one fourth (25 percent) of defecations c).
- •Sensation of incomplete evacuation more than one fourth (25 percent) of defecations d).
- •Sensation of anorectal obstruction/blockage more than one fourth (25 percent) of defecations e).
- •Manual maneuvers to facilitate more than one fourth (25 percent) of defecations (e.g., digital evacuation, support of the pelvic floor) f).
- •Fewer than three SBM per week g).
- •Loose stools are rarely present without the use of laxative h).
- •Insufficient criteria for irritable bowel syndrome
- •Subjects who are ready to provide written informed consent and who are ready to willingly participate and follow the protocol requirements of the clinical study.
- •(The Rome IV diagnostic criteria for Functional constipation, 2016).
排除标准
- •Subjects diagnosed with colonic inertia.
- •Subjects who have recently undergone abdominal surgery
- •Subjects with history of anorectal surgery.
- •4.Subjects having other functional gastrointestinal disorders other than Functional constipation (i.e., IBS, Belching disorders etc.)
- •Subjects diagnosed with structural abnormalities, like: i.
- •Anorectal: rectal prolapse, rectocele, rectal intussusceptions, anorectal stricture, solitary rectal ulcer syndrome ii.
- •Perineal descent iii.
- •Colonic and rectal mass or tumor with obstruction e.g., adenocarcinoma iv.
- •Colonic stricture: radiation, ischemia, diverticulosis v.
- •Intestinal obstruction
- •Subjects with uncontrolled DM and hypertension and Tuberculosis.
- •Known cases of HIV, tuberculosis, hypo and hyperthyroidism
- •Known cases of renal or liver dysfunction.
- •Subjects diagnosed with neurological problems like, i.
- •Parkinson’s disease ii.
- •Multiple sclerosis iii.
- •Sacral nerve damage (prior pelvic surgery, tumor) iv.
- •Paraplegia v.
- •Autonomic neuropathy
- •Subjects on chronic medication (greater than 60 days) and or who are on medications known to cause constipation.
- •Pregnant or lactating females
- •Subjects allergic or atopic to any of the ingredients of the study medications
- •Other conditions, which in the opinion of the investigators makes the patient unsuitable for enrolment or could interfere in adherence to of the study protocol.
结局指标
主要结局
Change in frequency of bowel movements
时间窗: screening visit, baseline visit, day 7, day 14 and day 21
次要结局
- 1. Change in stool form using graded scale(2. Changes in symptoms of functional constipation including straining on defecation, sensation of incomplete evacuation, sensation of ano-rectal blockage, manual maneuvers required & average time spent for bowel evacuation)
研究者
Dr Narendra Mundhe
KVTR Ayurvedic College and Hospital, Boradi