Clinical validation of the efficacy of Kayam Churna and Kayam Tablet and Advance Kayam Granules in managing functional constipation and related digestive parameters.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- 1.Assessment of change in the frequency of bowel movements using a bowel diary will be done at screening, day 1, day 7, day 15, and day 30.
研究概览
简要总结
Functional constipation is a common and often distressing gastrointestinal condition characterized by infrequent or difficult bowel movements. While various treatments exist, the search for safe and effective therapies continues. Traditional Ayurvedic formulations, such as ’Kayam Churna’, ’Kayam Tablet’, and ’Advance Kayam Granules’, have been used in traditional Indian medicine to address digestive issues, including constipation. However, their clinical efficacy and safety in managing this condition require rigorous scientific investigation.
This study aims to systematically evaluate the clinical efficacy of these Ayurvedic formulations in improving bowel movement frequency, consistency, and overall constipation symptoms. It will assess their impact on various digestive parameters, such as stool consistency, abdominal pain, bloating, and quality of life. Furthermore, the study will meticulously monitor for any adverse events or side effects to determine the safety and tolerability of these formulations.
By conducting this rigorous clinical validation, the study aims to generate robust scientific evidence to support or refute the traditional claims of these Ayurvedic formulations in managing functional constipation. This evidence will be invaluable for healthcare professionals and patients in making informed decisions regarding the use of these traditional therapies for this prevalent condition.
In conclusion, this study is crucial in bridging the gap between traditional medicine and modern scientific evidence. It will provide valuable insights into the efficacy of these Ayurvedic formulations, potentially offering a safe and effective alternative or adjunct therapy for individuals suffering from functional constipation with digestive health.
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
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Males and Females between 30-60 years of age (both inclusive);
- •Participants agreeing with two or more of the following complaints for the last 3 months: a) Straining during at least 25% of defecations: b) Lumpy or hard stools at least 25% of defecations: c) Sensation of incomplete evacuation of at least 25% of defecations: d) Sensation of anorectal obstruction/blockage at least 25% of defecations: e) Manual maneuvers to facilitate at least 25% of defecations e.g., digital evacuation, and support of the pelvic floor: f) Fewer than three defecations per week;
- •Participants in whom loose stools are rarely present without the use of laxatives;
- •Participants having stool form between 1 to 3 on the Bristol Stool Form Scale;
- •Participants willing and able to provide signed informed consent form prior to any study related procedures;
- •Participants having hyperacidity;
- •Participants having gases and indigestion;
- •Participants having headaches induced by gases;
- •Comorbid participants on stable medication for the last three months, with no worsening of symptoms and/or need for hospitalization; can be enrolled in the study at per discretion of the investigator.
排除标准
- •Participants with diagnosed colonic inertia;
- •Participants who have recently undergone abdominal surgery;
- •Participants with a history of anorectal surgery;
- •Participants having functional gastrointestinal disorders other than functional constipation i.e. IBS, Belching disorders, etc;
- •Participants diagnosed with structural abnormalities, like anorectal: rectal prolapse, rectocele, rectal intussusceptions, anorectal stricture, solitary rectal ulcer syndrome, perineal descent, colonic or rectal mass or tumor with obstruction e.g. adenocarcinoma, colonic stricture: radiation, ischemia, diverticulosis intestinal obstruction;
- •Participants with serious uncontrolled & diagnosed systemic ailments like HIV, DM and Tuberculosis;
- •Participants with renal or liver dysfunction;
- •Participants with diagnosed neurological problems like, parkinson’s disease, multiple sclerosis, sacral nerve damage for example prior pelvic surgery, tumor, and paraplegia;
- •Pregnant or lactating women.
结局指标
主要结局
1.Assessment of change in the frequency of bowel movements using a bowel diary will be done at screening, day 1, day 7, day 15, and day 30.
时间窗: screening, day 1, day 7, day 15, and day 30.
2.Assessment of change in stool form assessed by the Bristol Stool Form Scale using bowel diary will be done at screening, day 1, day 7, day 15, and day 30.
时间窗: screening, day 1, day 7, day 15, and day 30.
3.Assessment of change in other symptoms of functional constipation (e.g., straining on defecation, sensation of incomplete evacuation, sensation of anorectal blockage, manual maneuvers required, and average time spent for bowel evacuation) using a Visual Analog Scale (VAS) will be done at screening, day 1, day 7, day 15, and day 30.
时间窗: screening, day 1, day 7, day 15, and day 30.
次要结局
- 1.Assessment of change in abdominal bloating, gas, acidity, indigestion, and gas-induced headaches using the Modified Gastrointestinal Symptom Rating Scale (GSRS) will be done at screening, day 1, day 7, day 15, and day 30.(2.Global assessment for overall improvement by the investigator and patient using a 4-point scale will be done on day 15 and day 30.)
研究者
Dr Ninad Naik
Lokmanya Medical Research Centre and Hospital