An Open-Label, Single-Arm, Single-Center Clinical Study to Evaluate the Safety and Efficacy of Stonequit Tablet in Subjects with Urinary Stones
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1.The Change in urinary stone size and number from Baseline to the End-of-Treatment, as measured by ultrasound imaging.
研究概览
简要总结
Background
Urolithiasis commonly known as urinary stone disease is one of the most prevalent urological disorders affecting 12-15% of the global population with a recurrence seen in 50% of the Subjects within 5 years. It is a condition that occurs due to supersaturation of urinary solutes such as calcium oxalate, uric acid, and phosphate leading to crystal formation in the kidneys, ureters, or bladder. It occurs due to lifestyle, dietary habits, low water intake, and climatic factors and these are considered to have contributed to the growing burden of urolithiasis in India. Management of this includes increased fluid intake, pain management, and surgical procedures like lithotripsy or ureteroscopy. However, these approaches do not guarantee prevention of recurrence, and some may be associated with high costs, procedural risks, and adverse effects. Ayurveda offers holistic and time-tested remedies for the urinary disorders including urolithiasis.
Stonequit Tablet a proprietary Ayurvedic Medicine is designed not only to help break and eliminate existing stones but also to reduce pain, inflammation, dysuria and prevent recurrence. Traditional usage and clinical experience have indicated promising outcomes. However, a scientific validation through a well-designed clinical trial to evaluate the safety and efficacy of the product is needed.
Purpose of the study
The purpose of this phase 3 clinical study is to evaluate the safety and effectiveness of Stonequit Tablet in reducing the size and number of urinary stones. It also aims to assess improvement in urinary stone-related symptoms using Visual Analogue Scale and improvement in Subject QoL using a QOL Questionnaire.
Result of the study:
A total of 60 participants with urinary stones were enrolled in the study. Out of these 58 participants completed the study and 2 participants were lost to follow up.
The mean age of the participants was 40.9 years and the mean body mass index was 27.34 kg per meter square. Both male and female participants were included in the study.
After 45 days of treatment with Stonequit Tablet a clear improvement was observed in all primary and secondary outcome measures.
Primary Outcome
There was a reduction in urinary stone size and number from baseline to Day 45 as assessed by ultrasonography. The mean stone size reduced from 9.68 mm at baseline to 6.78 mm at Day 45. The mean number of stones reduced from 1.57 at baseline to 0.88 at Day 45. These findings indicate a significant reduction in overall stone burden after treatment.
Secondary Outcomes
There was a consistent improvement in urinary stone related symptoms such as abdominal or flank pain burning micturition hematuria nausea and vomiting. The mean total symptom score based on visual analog scale reduced from 29.6 at baseline to 13.1 at Day 45 showing marked symptom relief.
Quality of life assessment showed improvement across all domains including urinary discomfort physical activity sleep quality social functioning psychological well being daily activities and overall quality of life by the end of the treatment period.
Safety Results
The treatment was well tolerated throughout the study. No serious adverse events were reported. All participants showed stable vital signs and laboratory parameters. Hematological and renal function parameters remained within normal limits indicating good safety of the study product.
Conclusion
The study results demonstrate that Stonequit Tablet is safe and effective in reducing urinary stone size and number and in improving symptoms and quality of life in subjects with urinary stones over a treatment period of 45 days.
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 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adults aged 18 to 75 years, of either gender 2.Diagnosis of urinary stones confirmed by ultrasound scan 3.Size of the urinary stones must be less than 15mm in maximum diameter 4.Subjects who are first time stone formers or with a history of recurrent urinary stones, presenting with symptoms such as flank pain, dysuria, or hematuria 5.Willingness to comply with the study protocol and attend all scheduled visits 6.Ability and willingness to provide written informed consent.
排除标准
- •1.Pregnant or lactating women 2.Subjects with any systemic disease requiring other medications or surgical intervention for their calculus condition 3.Body Mass Index which is greater than 40 kg per meter square due to the impact on hydration and metabolic balance 4.Cases requiring immediate surgical management or presenting with complicated urolithiasis 5.Active urinary tract infection or chronic renal infection 6.Subjects with uncontrolled diabetes mellitus, hypertension, symptomatic congestive heart failure, unstable angina, or recent myocardial infarction 7.Presence of other urogenital disorders that may interfere with outcomes 8.Use of any herbal or plant-based supplement for kidney stones within the past 3 months 9.Participation in another clinical study within 30 days prior to screening 10.Active alcohol or substance abuse, or history of the same within the last 24 weeks 11.Any psychiatric illness or condition that may affect adherence to the protocol 12.Any other medical condition, in the investigator’s opinion, that could compromise the safety of the Subject or study integrity.
结局指标
主要结局
1.The Change in urinary stone size and number from Baseline to the End-of-Treatment, as measured by ultrasound imaging.
时间窗: Day 0, Day 15, Day 30, Day 45
Stone Size: Measured in millimeters using standardized ultrasonographic techniques.
时间窗: Day 0, Day 15, Day 30, Day 45
Stone Number: Total count of stones present in the kidney, ureter, or bladder.
时间窗: Day 0, Day 15, Day 30, Day 45
2.Rationale: Reduction in stone burden is the most objective and clinically relevant marker of treatment efficacy in urolithiasis management.
时间窗: Day 0, Day 15, Day 30, Day 45
次要结局
- 1.Symptom Relief: Improvement in urinary stone-related symptoms, assessed using the Visual Analog Scale.(2.Change in Quality of Life score from Baseline to End-of-Treatment, assessed using a validated disease-specific QoL questionnaire.)
研究者
Dr Deepak M
Sri Lakshmi Super Speciality Hospital