A single arm clinical study to evaluate the efficacy and safety of Pankajakasthuri Daily Lax in improving bowel regularity of subjects with constipation
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1. Frequency of Bowel movement per day
研究概览
简要总结
Title: A Pilot Study to Evaluate the Efficacy and Safety of Pankajakasthuri Daily Lax in Subjects with Constipation
Investigator/Trial Location: Pankajakasthuri Ayurveda Medical College & PG Centre, Killy, Kattakada, Thiruvananthapuram, Kerala
Study Objectives: This single-arm Phase 2 clinical trial aims to assess the efficacy of Pankajakasthuri Daily Lax in improving bowel regularity and its safety profile in subjects suffering from constipation.
Study Design: An open-label clinical trial without a control group.
Study Population: Male and female subjects aged 18 to 60 years diagnosed with constipation (defined as fewer than 3 bowel movements per week or history of straining, hard stools, or incomplete evacuation).
Main Inclusion Criteria: Subjects willing to provide informed consent, not currently using laxatives, and meeting the criteria for constipation diagnosis.
Main Exclusion Criteria: Subjects with severe constipation, acute abdominal symptoms, gastrointestinal disorders, hypersensitivity to trial drug ingredients, or concurrent participation in other clinical trials.
Expected Number of Subjects: 30
Investigational Product: Pankajakasthuri Daily Lax, administered orally.
Duration of Experiment: 4 weeks
Assessment Criteria: Frequency and consistency of bowel movements, subjective symptoms (bloating, straining, incomplete evacuation), safety parameters (blood routine, LFT, RFT), and adverse reactions.
Assessment Schedule: Baseline (0th day), 7th, 14th, 21st, and 28th days (end of treatment), with a follow-up assessment on the 35th day.
Statistical Considerations: Appropriate statistical analysis will be performed to evaluate efficacy endpoints.
Conclusion: This study seeks to provide valuable insights into the potential of Pankajakasthuri Daily Lax as a safe and effective treatment option for constipation, addressing a common gastrointestinal issue that significantly impacts patient quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects willing and able to provide signed informed consent prior to any study related to procedure.
- •Subjects of either sex in the age group between 18 to 60 years.
- •Participants with a confirmed diagnosis of constipation, defined as fewer than 3 bowel movements per week, or a history of straining, hard stools, or incomplete evacuation.
- •Participants who have used laxatives in the past, but have not used them in the 2 weeks prior to study entry.
排除标准
- •Women who are pregnant, lactating or planning to become pregnant during the study period.
- •ii Subjects with severe constipation, defined as fewer than 1 bowel movement per week.
- •Subjects with symptoms of acute abdomen and intestinal obstruction.
- •Subjects with a history of gastrointestinal conditions such as inflammatory bowel disease, tumours, gastrointestinal obstruction or gastrointestinal surgery.
- •Subjects with known hypersensitivity to ingredients of the trial drug.
- •Subjects with History of Diabetes mellitus, hypertension, immunodeficiency or any illnesses that may be worsened by participation in the trial.
- •Subjects with history of alcohol or drug abuse.
- •Subjects participating in any other clinical trial.
结局指标
主要结局
1. Frequency of Bowel movement per day
时间窗: Evaluation will be done on baseline (ie; 0th day), 7th day, 14th day, 21st day and 28th day (end of treatment). And follow-up 1 week post treatment (35th day).
2. Consistency of bowel.
时间窗: Evaluation will be done on baseline (ie; 0th day), 7th day, 14th day, 21st day and 28th day (end of treatment). And follow-up 1 week post treatment (35th day).
3. Subjective criteria (bloating, straining, incomplete evacuation).
时间窗: Evaluation will be done on baseline (ie; 0th day), 7th day, 14th day, 21st day and 28th day (end of treatment). And follow-up 1 week post treatment (35th day).
次要结局
- 1. Blood routine, LFT and RFT will be done to evaluate the safety of the trial drug before (0th day) and after the treatment (28th day).(2. Reporting and assessment of Adverse reactions / side effects if any. Adverse events, such as cramping and diarrhoea will be carefully monitored throughout the study.)
研究者
Dr J Hareendran Nair
Pankajakasthuri Herbal Research Foundation