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临床试验/CTRI/2024/10/075206
CTRI/2024/10/075206招募中不适用

A Clinical study on the efficiency of Homoeopathic medicine Cephalandra indica 6C in Managing Albuminuria and controlling Blood glucose levels in Diabetic nephropathy patients

Vinayaka Missions Homoeopathic Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2024年11月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
35
试验地点
1
主要终点
1.Reduction in ACR

研究概览

简要总结

Diabetic nephropathy is the leading cause of renal replacement therapy and affects ∼40% of Type 1 and Type 2 diabetic patients. It increases the risk of death and is defined by increased Urinary Albumin Excretion (UAE) in the absence of other renal diseases. Diabetic kidney disease and End Stage Renal Disease (ESRD) have the most debilitating consequences among all diabetes complications. While considerable advances have been achieved in slowing the progression of diabetic nephropathy, the ultimate goal of arresting or reversing disease development is not achieved. Diabetic nephropathy is categorized into stages: microalbuminuria (UAE >20 μg/min and ≤199

μg/min) and macroalbuminuria (UAE ≥200 μg/min). Hyperglycemia is the main risk factors for the development of diabetic nephropathy. Screening for microalbuminuria should be performed yearly, starting 5 years after diagnosis in Type 1 diabetes or earlier in the presence of puberty or poor metabolic control. In patients with Type 2 diabetes, screening should be performed at diagnosis and yearly thereafter. Patients with micro- and macroalbuminuria should undergo an evaluation regarding the presence of comorbid associations, especially retinopathy and macrovascular disease. Achieving the best metabolic control (HbA1c <7%), treating systemic hypertension (<130/80 mm of Hg or <125/75 mm of Hg if proteinuria >1.0 gm/24 hrs and increased serum creatinine), and treating dyslipidemia (LDL cholesterol <100 mg/dl) are effective strategies for preventing the development of microalbuminuria, in delaying the progression to more advanced stages of nephropathy and in reducing mortality in patients with Type 2 diabetes.

Cephalandra indica

Cephalandra indica, Coccinia cordifolia (L.) Cogn), commonly known as Ivy Gourd, Little Gourd and Kovai belongs to family Cucurbitaceae. The plant had been used in Ayurvedic and Unani practice in the Indian subcontinent, as antidiabetic. C. indica is traditionally used as anti-inflammatory, antipyretic, analgesic, antispasmodic, antimicrobial, cathartic, antibacterial and expectorant. Terpenoids, steroids, carotenoids and flavonoid have been isolated from C. indica aerial parts. Cephalandra indica belongs to family Cucurbitaceae, also known as Kundru in Hindi and Ivy Gourd in English, is a perennial climbing herb with tuberous roots that grows in the wild in abundance in major parts of India. The plant has been used since ancient times for treating diabetes mellitus according to the science of Ayurveda.C.indica has been reported to have an insulin stimulating effect on β cells. The usefulness of C. indica for diabetes mellitus in mother tincture in Homeopathy has also been documented through case reports . Chemical constituents: The whole plant contains various phytochemical constituents such as triterpenoids, steroids, carotenoids, aliphatic hydrocarbons and certain vitamins. ANTIDIABETIC ACTIVITY These mechanisms of action include stimulation of insulin secretion, regeneration of β-cells, restoration of antioxidant enzymes, enhancement of glucose uptake, regulation of metabolic enzymes, amelioration of lipid profiles, and inhibition of digestive enzymes. Here we summarize how C. grandis exerts antidiabetic activity via the aforementioned mechanisms of action.

Clinical studies: C. indica is used to treat “sugar urine” (madhumeha) in Ayurveda, a traditional Indian healing system. The mechanism of action is not well understood but appears to have insulin-mimetic properties. While assessing the quality of the herb for glycemic control by the American Diabetes Association Criteria for Clinical Guidelines, which rated C. indica with an A-rating and having supportive evidence with at least one adequate randomized clinical trial. Pharmacological reports: C. indica has been reported to exhibit anti-inflammatory, antipyretic, antimicrobial, antidiabetic, antiulcer and antioxidant activities. A survey of literature revealed

that though few scientific reports have validated traditional claims of C. indica aerial parts but employed crude uncharacterized extracts.

Since there is difficulty in management and insufficient treatment methods so far for Diabeteis and Nephropathy, this research study on Cephalandra indica is proposed.

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
40.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • 9.5% ACR: 30-299 mg/g eGFR: 60-90ml/min/1.73m2.

排除标准

  • Diabetic patients with other complications Patients with end stage renal disease.

结局指标

主要结局

1.Reduction in ACR

时间窗: 120 Days

2.Reduction in blood glucose level

时间窗: 120 Days

次要结局

  • 1.Increase in eGFR(2.Reduction in Urine albumin)

研究者

发起方
Vinayaka Missions Homoeopathic Medical College and Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

ANJU T R

Vinayaka Missions Homoeopathic Medical College and Hospital

研究点 (1)

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