跳至主要内容
临床试验/CTRI/2018/09/015869
CTRI/2018/09/015869已完成2 期

A randomized comparative clinical study to evaluate the efficacy of mustadi kwatha and vangeshwara rasa in the management of madhumeha w.s.r. to type 2 Diabetes mellitus.

National Institute of Ayurveda1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2019年11月30日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
45
试验地点
1
主要终点
Assessment of changes in Blood Sugar Level (FBS,PPBS) and specific signs and symptoms of Madhumeha (Type 2 Diabetes Mellitus)

研究概览

简要总结

DiabetesMellitus (DM) is a clinical syndrome characterised by hyperglycaemia due toabsolute or relative deficiency of insulin. Diabetes Mellitus is classifiedinto two broad categories: Type 1 DM and Type 2 DM. Type 1 DM is a result ofabsolute deficiency of insulin while Type 2 DM is a heterogeneous group ofdisorders characterised by variable degrees of insulin resistance, impairedinsulin secretion and increased glucose production.

DiabetesMellitus usually presents with symptoms like polyuria, polydipsia andpolyphagia. Over time, DM can damage the heart, blood vessels, eyes, kidneysand nerves. According to aetiological factors, pathogenesis and clinicalfeatures, Diabetes mellitus can be correlated with Madhumehain Ayurveda. Madhumeha is the result of untreated Prameha. It is VatajaPrameha where the Vatadepletes all Dhatuexcept AsthiDhatu and Oja by excreting them through urine leadingto *Prabhuto Avila Mutrata.*Although new drugs and therapeutics are emerging for the management ofDiabetes Mellitus (DM), its prevalence is increasing at an alarming rate. DMdoes not come alone it bringswith itself various acute and chronic metabolic complications of hyperglycaemiaaffecting every organ from head to toe. Once an individual is diagnosed with DMthe dosage of medicine is everincreasing and ultimately insulin has to be given for glycemic control in mostof the cases.

Ayurveda has a great potential inthe management of Madhumeha (Type 2 DM) and itsassociated complications.This study finds that Type 2 diabetes mellitus is more prevalent in theelderly population. More specifically, the prevalence of disease is more in 4th, 5th, and 6th decade of life. Thisfinding is consistent with many other studies across different parts of theworld. Similarly, the prevalence of disease is more in patients withsedentary life, lack of exercise and faulty food habits in comparison with thepatients performing regular physical activity and having regular healthy diet.

Thus, the results of this study imply thatfood and exercise play a major role in controlling the blood glucoselevel. Another interesting findings of this study is that only a few ofthe 45 registered patient have a classical symptoms of the disease whereas mostof the patient are symptomless, but those patients were having a high bloodsugar level. This suggests the need of regular medical check-up the elderlypeople because these people might have been affected by the disease even ifthey do not show any related symptoms.

In thepresent study both Mustadi Kwatha and Vangeshwara Rasa reduce many symptomsof  Madhumeha (Diabetes Mellitus) thatinclude Prabhoota Mutrata(Polyuria), Avila Mutrata (Turbidity), Trishnadhikya (Excessive Swaeting), Kara Pada Supti (Numbness of Extremities)andDaurbalya(Weakness) significantly. While in Kara Pada Daha (Burning sensation inhands and Feet) and in Kshudadhikya  (Polyphagia) minimumimprovement was observed.

Thesample size of this study may not be adequate to determine the effectiveness ofthe drugs in some variables like Avila Mutrata, Karapada Daha and Kshudhadhikyawhich are present in fewerpatient. Regarding overall improvementin objective parameters, Vangeshwara Rasa alone and in combination with Mustadi Kwathaprovide highly significant p<0.001 reduction in FBS and PPBS, While Mustadi Kwatha provide significantp<0.05 reduction in FBS and PPBS. The trial drug Mustadi Kwatha is more effective inreducing serum cholesterol and triglyceride in comparison to Vangeshwara Rasa. Similarly, Vangeshwara Rasa have shown significantincrement in HDL as compare to Mustadi Kwatha.

Theseresults suggest the positive effect of the trial drugs in this study. The results werenon-significant in parameters like SGOT, SGPT, Blood Urea, Serum Creatinine,Urine protein. They were within normal range after 45 days of administration ofthese drugs. The findings imply that there were no any adverse effect of thesedrugs. Diabetes is often associated with obesity, dyslipidaemia,hypertension, insulin resistance, known as metabolic syndrome.

From thepresent study we can say that both the drug Mustadi Kwatha and Vangeshwarain combined form are capableto handle Diabetes as well as its associated condition.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
30.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • •1.Patient willing to sign the consent form. 2.Patients in the age group of 30-70 years. 3.Patients with Fasting Blood Sugar (FBS) in the range of 126mg/dl – 250mg/dl or Post Prandial Blood Sugar (PPBS) in the range of 200mg/dl – 300 mg/dl and Glycosylated Haemoglobin (HbA1c) 6.5%.

排除标准

  • •1.Patients below 30 years & above 70 years of age.
  • •2.Patients having Type 1 DM.
  • •3.Patients of Type 2 DM who are on insulin therapy.
  • •4.Patients having any serious illness like coronary artery disease, malignancy, kidney failure etc.
  • •5.Patient whose Fasting Blood Sugar (FBS) > 250 mg/dl or Post Prandial Blood Sugar (PPBS) > 300 mg/dl or Glycosylated Haemoglobin (HbA1c) > 9.0%.
  • •6.DM with complications.
  • •7.Pregnant women and lactating mother.

结局指标

主要结局

Assessment of changes in Blood Sugar Level (FBS,PPBS) and specific signs and symptoms of Madhumeha (Type 2 Diabetes Mellitus)

时间窗: 45 days

次要结局

  • Any adverse effect in the values of hematological test and in clinical signs and symptoms.(45 days)

研究者

申办方类型
Government medical college

研究点 (1)

Loading locations...

相似试验

A study of mustadi kwatha and vangeshwara rasa in... | 临床试验