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临床试验/CTRI/2024/09/073711
CTRI/2024/09/073711尚未招募不适用

Randomized Controlled Open label Clinical trial to Study add on effect of Triphaladi Kashay alongwith Metformin in management of Madhumeha w.s.r to type 2 Diabetes Mellitus

Dr.VJD Gramin Ayurved Mahavidyalaya1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年9月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Symptoms like1. Prabhutmutrata

研究概览

简要总结

Ayurveda is a natural health care system that originated in India since the beginning of civilization. It is described by Acharya Charak that to achieve purushartha chatushtaya, Arogya is necessary. Ayurveda strongly emphasize on preventive and promotive aspects of health rather than curative. The concepts of Dincharya, Ritucharya, Sadvritta and Achara Rasayana along with guidelines for healthy diet and lifestyle is well established in Ayurveda, but in current scenario, hardly any one follows it as a result ,there is tremendous rise in lifestyle disorders as pandemics, Diabetes being most menacing among them. Diabetes is fourth leading cause of global death by disease. Type 2 DM is responsible for approximately 90% of cases. Therefore today’s India is called nation of DM.

Madhumeha "Richman’s disease", since Vedic period, is familiar to mankind. Madhumeha is a disease in which mutra (Urine) of the patient attains similar property like those of madhu (Honey). It is documented as one among the twenty obstinate urinary disorders i.e. Prameha. It is also explained that, when the other Prameha are left untreated, this lead to the condition called Madhumeha. So Madhumeha can also be considered as an advanced condition or stage of Prameha.

Diabetes Mellitus is a chronic disorder of carbohydrate metabolism, marked by hyperglycemia and glycosuria and resulting from inadequate production or use of insulin. Traditionally, Madhumeha can be equated with diabetes mellitus, as many similarities in view of their causative factors, pathogenesis, signs and symptoms, classification, complications and treatment has been found.

Diabetes mellitus is a clinical syndrome characterised by hyperglycemia caused by an absolute or relative deficiency of insulin & insulin resistance lack of insulin, whether absolute or relative, affects the metabolism of carbohydrates. Type II diabetes mellitus has become a global epidemic. Modern medicines, despite offering a variety of effective treatment options can have several adverse effects.

Diabetes Mellitus is classified into 2 types. 1. Type I (IDDM/juvenile diabetes) 2. Type II (NIDDM/adult onset diabetes) With regard to diabetes mellitus, Sahaj prameha and kulaj prameha correlate with type I diabetes and apathyanimittaja prameha correlates with type II diabetes. According to Ayurveda Prameha is Included in one of the Mahagadas. In prameha maximum no. of strotas, all 7 Dhatus & ojas get involved & prameha shows group of many symptoms due to this condition of patient goes on deteriorating day by day. The Ayurvedic management of Diabetes aims not only to achieve a strict glycemic control but also to treat the main & root cause of disease. Many drugs & formulae have prescribed for internal & external use in Ayurved samhitas, one of which is “Triphaladi Kashay” .This thesis is an attempt to study the add on effect of “Triphaladi Kashay alongwith Metformin” in Madhumeha & improve the personal & social life of a patient, it is an effort of scholar to observe the add on effect of Triphaladi kashay alongwith Metformin in Madhumeha (NIDDM)

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

入选标准

  • Patient willing for clinical trial and written consent.
  • Age group from 30 to 70 yrs.
  • Patients with newly diagnosed as well as known case of type 2 diabetes mellitus already taking Tab.
  • Metformin 500 mg only.
  • The patients having symptoms of prabhutmutrata, trushnadikya, kshudhadikya, daurbalya, alasya .
  • 5.Blood Sugar Level (Fasting-120 to 159 mg/dl) (Post prandial-160 to 250 mg/dl) 6.Hba1c 6.5 to 9
  • Patients without any complication of madhumeha (type 2 D.M.) or without any other systemic disorder.

排除标准

  • Patients not willing for clinical trial and written consent.
  • Sahaj and jatha janya madhumeha or patients with type 1 diabetes mellitus
  • Patients on insulin therapy or Steroid Therapy.
  • Patients having blood sugar more than 250mg/dl.
  • 5.Subjects under any other oral hypoglycaemic therapy other than Tab.Metformin 500 mg
  • Patients having complication of madhumeha or any other systemic disorder like renal disorder, heart disease, Neurological,psychological disorder and Carcinoma.
  • 7.Pregnant and Lactating Women.

结局指标

主要结局

Symptoms like1. Prabhutmutrata

时间窗: 30 days,60 days,90 days after starting treatmemt

2. Trushnadikya

时间窗: 30 days,60 days,90 days after starting treatmemt

3. Kshudhadhikya

时间窗: 30 days,60 days,90 days after starting treatmemt

4. Daurbalya

时间窗: 30 days,60 days,90 days after starting treatmemt

5.Alasya will be decreased and Control over Madhumeha with reference to Type 2 Diabetes Mellitus

时间窗: 30 days,60 days,90 days after starting treatmemt

次要结局

  • Decrease in Symptoms of Madhumeha and Control over BSL(18 Months)

研究者

发起方
Dr.VJD Gramin Ayurved Mahavidyalaya
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Unmesh Vikas Deshmukh

Dr.VJD Gramin Ayurved Mahavidyalaya,Patur,Akola

研究点 (1)

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