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临床试验/CTRI/2025/02/080528
CTRI/2025/02/080528尚未招募2/3 期

EVALUATION OF YOGAVAHITVA OF MADHU WITH SPECIAL REFERENCE TO SAMYOGA ON ANTI- HYPERGLYCAEMIC ACTIVITY OF TRIPHALA IN PRE-DIABETES – A RANDOMIZED OPEN LABELLED CONTROLLED CLINICAL STUDY

DR GRAMA SRIRANGARAJU SAHANA1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年3月1日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To Evaluate the Anti-Hyperglycaemic effect of Triphala in Pre-Diabetes.

研究概览

简要总结

Diabetes Mellitus is one of the largest global public health concerns, imposing a heavy global burden on public health as well as Socio-economic development. Diabetes Atlas 2021 reports that 10.5% of the adult population ranging from 20-29 years have Diabetes. By 2045, IDF projections show that 1 in 8 adults, will be living with Diabetes, an increase of 45%. In India, there are estimated 77 million people above the age of 18 years and nearly 25 million are prediabetics with more than 50% of people are unaware of their diabetic status. Hyperglycaemia-induced oxidative stress is central to the development of diabetes. Studies have shown that polyphenols could reduce and reverse oxidative stress associated hyperglycemia. Phenolics due to their poor bioavailability often fail in getting absorbed properly from gut and hence need bio-availability enhancers, which could bring enhanced effects. Honey has lower glycemic index and decreases the fasting blood glucose. Honey protects against metabolic syndrome by exerting antidiabetic activity. It keeps the gut healthy as it increases the bioavailability of Phenolics which are digested by the Gut microbe. The active principles of Triphala are predominantly hydrolysable tannins. Their antioxidant activity of Triphala correlates with their Antidiabetic property. Adults treated with Intensive Lifestyle Treatment have chances of achieving remission of diabetes.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
25.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients diagnosed with Pre-Diabetes irrespective of gender and Socio-Economic status will be selected.
  • Subjects of age group 25-60 years will be selected Fasting Blood Sugar level: 100-125mg/dl Post Prandial Blood Sugar level: 140-199mg/dl HbA1c: 5.7%-6.4% Patients with pre-obese category and class 1 obesity Patients fulfilling the Diagnostic criteria with or without associated complaints of Polyuria, Polydipsia, Polyphagia, Tiredness and Weight parameter.

排除标准

  • Any other systemic disorder which requires emergency management.
  • Long term Diabetics with severe complications such as Diabetic neuropathy, Diabetic Nephropathy, Retinopathy, Ischemic Heart Disease, Gestational Diabetes, Diabetes Mellitus Type 1 and complaints related to mobility.
  • Secondary Diabetics, Bronze Diabetes and Stage 2 hypertensives.
  • Pregnant and Lactating Women.
  • Patients will Liver cirrhosis, Sexually Transmitted Disorders, HIV, Pancreatitis, Hepatitis.

结局指标

主要结局

To Evaluate the Anti-Hyperglycaemic effect of Triphala in Pre-Diabetes.

时间窗: 6-12 weeks

To Evaluate the Yogavahitwa of Madhu with special reference to Samyoga on

时间窗: 6-12 weeks

Anti-Hyperglycaemic activity of Triphala in Pre-Diabetes.

时间窗: 6-12 weeks

To compare the Anti-Hyperglycaemic effect of Triphala and Madhu mishrita

时间窗: 6-12 weeks

Triphala with Standard Care [Diet and Exercise]

时间窗: 6-12 weeks

次要结局

  • Fasting Blood Sugar level: 100-125mg/dl(Post Prandial Blood Sugar level: 140-199mg/dl)

研究者

发起方
DR GRAMA SRIRANGARAJU SAHANA
申办方类型
Other [individual]
责任方
Principal Investigator
主要研究者

DR GRAMA SRIRANGARAJU SAHANA

JSS AYURVEDA MEDICAL COLLEGE AND HOSPITAL, MYSURU, KARNATAKA

研究点 (1)

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