跳至主要内容
临床试验/CTRI/2024/05/067448
CTRI/2024/05/067448招募中2 期

An Open Labelled Randomised Comparative Clinical study to Evaluate the efficacy of Virechana (Medicated Purgation) and Nisha Amalaki Yoga in the management of Prediabetes

Parul Institute of Ayurved1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2024年6月1日最近更新:

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
48
试验地点
1
主要终点
To compare the effect of Virechana followed by Nisha Amalaki Yoga & Nisha Amalaki Yoga alone in patients on the basis of HbA1C,Lipid Profile,Fasting and post prandial blood sugar level in patients of Prediabetes.

研究概览

简要总结

In modern science, there isn’t a specific treatment for prediabetes, instead, healthcare professionals recommend lifestyle modifications such as dietary changes and increased physical activity to manage the condition. Many individuals diagnosed with prediabetes, despite being aware of the risks, struggle to implement necessary lifestyle modifications. The challenge often stems from entrenched habits, societal influences, and a lack of perceived urgency. Inertia sets in as people find it difficult to break free from familiar patterns. Procrastination and misconceptions about the severity of prediabetes can lead to complacency.Limited research exists on prediabetes in Ayurveda, hindering comprehensive understanding and treatment approaches. If we go through the literature of Prameha, all acharyas described Prameha Poorvarupa in details. Prameha is Bahudoshaja Vyadhi and in early course of the disease Shodhana must be the choice of treatment as at this stage predominance of Kapha and

Pitta Dosha found in patients. Virechana is the best Shodhana therapy for the elimination of Dosha through the lower route of the body. By the elimination of Kapha and Pitta, obstructions are removed (Avarana), which are caused by Vata. At the same time, the elimination of Kapha also alleviates the vitiated Kapha Vargiya Dushyas. In this way, the Virechana therapy reduces the vitiation of Dosha and the Dushya. When the Shamana drug will be given to the patients whose vitiated Doshas were already eliminated by the Virechana therapy, ultimately it may provide better result to the patients. Currently, there is a lack of available data on the implementation of Virechana Karma in the treatment of conditions like prediabetes followed by Shaman Aushadha. The scarcity of research or documented cases highlights the need for further exploration and investigation into the effectiveness and appropriateness of employing Virechana in managing prediabetes hence this study will be undertaken.

Nisha Amalaki Yoga possesses the Tridoshahara characteristic with a specific emphasis on its Kaphahara property.It acts on vitiated Kapha ,Meda and Kleda, demonstrating the capability to enhance the tone of the Saptadhatus while reducing Dhatushaithilya.Through its Deepan and Pachan attributes, Nisha Amalaki Yoga influences Jatharagni and Dhatwagni, thereby decreasing the presence of Ama and Kleda in the body.It enhances Dhatwagni, contributing to

the amelioration of disturbed metabolism. Nisha Amalaki Yoga exhibits Deepan, Pachan and Anuloman properties, which collectively work on Strotodushti and glucose metabolism. Its Ruksha Guna facilitates Kleda Shoshana, and may be beneficial in the Sampraprti Vighatan of Prameha. Hence, evaluation of the medicine in pre-diabetes may be useful and needs to be explored. In view of Ayurvedic principles of management of Prameha after Shodhana treatment is completed, Shodhana plays important role. Hence in current study, it is praposed to evaluate effect of both Shodhana and Shamana in comparision with Shamana alone in the management in prediabetes.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • Patients of pre-diabetes diagnosis according to American Diabetes Association (HbA1C.
  • 5.7 to 6.4 %). Patients eligible for Virechana. Patients willing to sign informed consent and able to participate in the study procedure.

排除标准

  • Known cases of Diabetes Mellitus, Insulin Dependent Diabetes, Juvenile Diabetes Mellitus And Gestational Diabetes.
  • Known cases of Major Systemic Diseases like IHD, Malignancies, Uncontrolled Hypertension.
  • Patients on prolonged medication (more than 6weeks) with Corticosteroids or any other Drug that may have an influence on the outcome of the study.
  • Pregnant and lactating women.
  • Patients with active infective diseases like Tuberculosis, Hepatitis B.
  • Immunocompromised patients.

结局指标

主要结局

To compare the effect of Virechana followed by Nisha Amalaki Yoga & Nisha Amalaki Yoga alone in patients on the basis of HbA1C,Lipid Profile,Fasting and post prandial blood sugar level in patients of Prediabetes.

时间窗: HbA1C-On Screening Visit and 90th Day. | Lipid Profile-On Screening Visit,After Virechana Karma and 90th Day. | FBS-On Screening Visit,After Virechana Karma,30th Day,60th Day and 90th Day. | PP2BS-On Screening Visit,After Virechana Karma,30th Day,60th Day and 90th Day.

次要结局

  • To compare the effect of Virechana followed by Nisha Amalaki Yoga and Nisha Amalaki Yoga alone in patients on the basis of BMI,Body composition parameters and other subjective parameters in patients of Prediabetes.(On Screening Visit,After Virechana Karma,15th Day,30th Day,45th Day,60th Day,75th Day and 90th Day.)
  • To study the safety of Virechana and Nisha Amalaki Yoga in patients of Prediabetes.(On Screening Visit,After Virechana Karma,15th Day,30th Day,45th Day,60th Day,75th Day and 90th Day.)

研究者

发起方
Parul Institute of Ayurved
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Anany Trivedi

Parul Institute of Ayurved

研究点 (1)

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