A Prospective, Multi-Arm, Open-Label, Singl-Centre Clinical Study to Evaluate the Safety and Efficacy of Surabhi Saara in Patients with Diabetes, Varicose Veins, PCOD, Ulcers and Acidity
概览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Surabhi Pharmaceuticals
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1. Meantime for clinical recovery as per clinical recovery criteria
概览
简要总结
The study, titled "A Prospective, Multi-Arm, Open Label, Single-Centre Clinical Study to Evaluate the Safety and Efficacy of Surabhi Saara in Patients with Diabetes, Varicose Veins, PCOD, Ulcers, and Acidity," aims to investigate the impact of Surabhi Saara on individuals with diverse medical conditions.
The study therapy involves the administration of one capsule before breakfast and dinner, with dietary recommendations and randomization based on patients’ symptoms and screening results. The study, conducted at a single centre, plans to enroll 50 evaluable patients across multiple arms without formal statistical assessment.
The primary objective is to assess the efficacy of the test product in reducing symptoms associated with diabetes, varicose veins, PCOD, mouth ulcers, and acidity. Additionally, the secondary objective focuses on evaluating the safety of the test product in patients with these health concerns.
Inclusion criteria vary across different arms of the study:
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Arm A (Diabetes): Includes patients with Type 1 and Type 2 Diabetes, irrespective of ongoing treatment with other systems of medicine.
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Arm B (Varicose Vein): Encompasses patients with unilateral and bilateral varicose veins in the lower limbs.
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Arm C (Polycystic Ovarian Disease): Involves female patients aged 20-35 years with USG pelvis confirming polycystic ovaries and irregular menstrual cycles.
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Arm D (Mouth Ulcers): Enlists patients with sores or erosion in the inner lining of the mouth, regardless of ongoing treatment with other systems of medicine.
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Arm E (Acidity): Includes patients exhibiting signs of acidity, determined through pH testing.
Exclusion criteria for each arm are specified to exclude individuals with certain conditions that may impact the study outcomes, such as pregnancy, severe cases of diabetes, bleeding disorders, severe systemic illness in PCOD cases, and chronic alcoholism or habitual tobacco use.
Primary Outcome Measures
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Blood Sugar Levels (RBS): The average blood sugar level decreased significantly by 27.4% after treatment.
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Varicose Vein Symptoms (VCSS): Symptoms related to varicose veins improved by 63.2%.
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Varicose Vein Severity (CEAP): The severity of varicose veins reduced by 51.9%.
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Ovarian Volume: The average ovarian size reduced by 38.2%, indicating improvement in ovarian health.
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Follicle Count: The number of ovarian follicles reduced by 55.1%, showing progress in hormonal balance.
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Endometrial Thickness: The thickness of the uterine lining improved by 27.8%, reflecting better menstrual health.
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Menstrual Cycles (per year): The number of menstrual cycles increased by 128.6%, indicating improved reproductive health.
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Days Between Menstrual Cycles: The average gap between menstrual cycles reduced by 51.3%, normalizing menstrual patterns.
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Mouth Ulcers (Number): The number of mouth ulcers decreased by 58.3%, showing effective healing.
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Mouth Ulcer Size: The size of mouth ulcers decreased by 56.4%.
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Pain (VAS Score): Pain levels associated with ulcers reduced by 51.3%.
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Gut Acidity (pH): Gut acidity reduced by 34.1%, showing significant relief from acidity symptoms.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Arm A ( Diabetes ) 1.Patients with Type 1 and Type 2 Diabetes 2.Cases which are already diagnosed and who are on other systems of medicine treatment will also be taken into consideration.
- •Arm B (Varicose Vein) 1.Patients with unilateral and bilateral varicose vein in the lower limbs 2.Diagnosed case of varicose vein in lower limb Arm C (Polycystic Ovarian Disease) 1.Female patients of age between 20-35years 2.USG pelvis showing polycystic ovaries 3.Irregular menstrual cycle: Eight or fewer menstrual cycles in the past year or inter menstrual periods of 45 days or longer Arm D (Mouth ulcers) 1.Patients with sores or erosion in the inner lining of mouth 2.Cases which are already diagnosed and who are on other systems of medicine treatment will also be taken into consideration.
- •Arm E (Acidity) 1.Patients exhibiting signs of Acidity (pH test is done to detect the same).
排除标准
- •Arm A (Diabetes) 1.Pregnant and lactating mothers 2.Severe cases of Diabetes Arm B ( Varicose Vein) 1.Patients with the bleeding disorders Arm C (Polycystic Ovarian Disease) 1.PCOD cases with severe Systemic illness 2.Pregnant and lactating mothers Arm D and Arm E (Mouth ulcers and Acidity) 1.Chronic alcoholics and Habitual Tobacco chewers 2.Subjects with chronic immune diseases like HIV.
结局指标
主要结局
1. Meantime for clinical recovery as per clinical recovery criteria
时间窗: Evaluations are performed on Day 1,30,60,90,120,150,180,210 and 240.
2. Drop in random blood glucose level in the sample group at the end of medication
时间窗: Evaluations are performed on Day 1,30,60,90,120,150,180,210 and 240.
3.Symptomatic Relief based on Venous Clinical Severity Score and CEAP score
时间窗: Evaluations are performed on Day 1,30,60,90,120,150,180,210 and 240.
4.To improve the quality of life in subjects affected with varicose veins
时间窗: Evaluations are performed on Day 1,30,60,90,120,150,180,210 and 240.
5.Normal appearing of ovary confirmed by TV USG
时间窗: Evaluations are performed on Day 1,30,60,90,120,150,180,210 and 240.
次要结局
- 1.Progress in the signs & symptoms based on the standard pattern will be applied before & after treatment.(2.Relief in acidity symptoms after administration of medication.)
研究者
Dr Manjunath U
Good Life Hospital