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临床试验/CTRI/2024/05/067508
CTRI/2024/05/067508尚未招募2 期

Single centric Non randomized open clinical trial Phase II in Madhumegam (Type II Diabetes mellitus) with Siddha Medicine Pavala silasathu parpam

Theenathayalan S1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年9月2日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Reduction in HbA1C level (atleast 20%)

研究概览

简要总结

Diabetes mellitus is a clinical syndrome characterised by increase in plasma blood glucose (Hyperglycemia). There are two types of diabetes mellitus ,Type I and Type II. Type I Diabetes Mellitus is caused by autoimmune destruction of beta cells in the pancreas, resulting in absolute insulin deficiency, whereas Type I Diabetes Mellitus is due to insulin deficiency or defective action of insulin or both. Chronic hyperglycemia is responsible for diabetes specific microvascular complications affecting the eyes (retinopathy), kidneys (nephropathy) and feet (neuropathy).

India is deemed as the world’s capital of Diabetes. In 2021, approximately 537 million adults (20-79years of age ) are living with diabetes. The total number of people living with diabetes is projected to rise to 643 million by 2030 and 783 million by 2045.The diabetic population in the country close to hitting the alarming mark of 69.9 million by2030.

The classical siddha medicine formulation “PAVALA SILASATHU PARPAM” mentioned in "Kannusamy Parambarai Vaithiyam". is indicated for Madhumegam (Type II Diabetes mellitus). Moreover this formulation has anti-diabetic activity that had been proven scientifically .So the author tries to evaluate its efficacy in the management of Type II Diabetes Mellitus in a non-randomised open clinical trial.

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
30.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.sex:all genders 2.Polyuria 3.Polydipsia 4.Polyphagia 5.HbA1C-6.5%-8%.

排除标准

  • 1 Pregnant women 2 Lactating mothers 3 Insulin dependent Diabetes mellitus 4 Patient having severe comorbidity like Cardiovascular disease 5 Diabetic nephropathy 6 Diabetic retinopathy 7 Benign Prostatic hyperplasia 8 Diabetes insipidus The above criteria will be excluded clinically or based on the available medical reports.

结局指标

主要结局

Reduction in HbA1C level (atleast 20%)

时间窗: 90 days

次要结局

  • Reduction in clinical symptoms Polyuria,Polydipsia,Polyphagia &Fatigue(90 days)

研究者

发起方
Theenathayalan S
申办方类型
Other [Self ]
责任方
Principal Investigator
主要研究者

Theenathayalan S

Government Siddha Medical College, Chennai

研究点 (1)

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