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临床试验/CTRI/2026/01/100117
CTRI/2026/01/100117尚未招募3 期

Randomized comparative clinical trial To evaluate the efficacy of Madhumehavinashini Gutika with and without Jwarahara Kashaya in the management of Madhumeha with special reference to Diabetes Mellitus Type II.

National institute of ayurveda1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年6月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
入组人数
60
试验地点
1

研究概览

简要总结

Diabetes Mellitus is a clinical syndrome characterized by hyperglycemia due to absolute or relative deficiency of insulin. It is characterized by polyuria, polydipsia, polyphagia, fatigue etc.It is one of the lifestyle disorders whose prevalence is rising more rapid in almost all countries. It is a leading cause of morbidity and mortality all over the world. Despite the availability of treatments like oral hypoglycemic agents, achieving optimal glycemic control remains challenging for many patients. The long-term effectiveness and side effects of pharmacological interventions can make  managing T2DM even more complex, thus emphasizing the need for exploring alternative therapies Though there are so many ongoing and completed studies on efficacy of Ayurvedic management of DM, most of them shows is effective in reducing the subjective parameters and no much change is observed in FBS, PPBS. So Conducting larger clinical trials with well-defined objective measures like FBS, PPBS,  and other biomarkers could help validate the effectiveness of these therapies and potentially expand treatment options for patients with T2DM. Investigating the efficacy of Jwarahara Kashaya in comparison to Madhumehavinashini gutika offers an opportunity to   potentially improve outcomes. Keeping all these facts in mind, it has been decided to conduct a clinical study entitled as “RANDOMISED COMPARATIVE CLINICAL TRIAL TO EVALUATE THE EFFICACY OF MADHUMEHAVINASHINI GUTIKA WITH AND WITHOUT JWARAHARA KASHAYA IN THE MANAGEMENT OF MADHUMEHA WITH SPECIAL REFERENCE TO DIABETES MELLITUS TYPE II”

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
30.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients between age group 30-65 years 2.Patient having signs and symptoms of Madhumeha 3.Diagnosed cases of Type 2 Diabetes Mellitus 4.Patient with FBS –in range of 126-250mg/dl OR 5.PPBS-in range of 160-350mg/dl OR BOTH 6.Patients on Oral hypo-glycemic drugs for a duration less than or equal to 1 year with poor glycemic control.(as mentioned in above points) 7.Willingness to participate in the study and provide informed consent.

排除标准

  • 1.Pregnant or lactating women 2.Patients having Type-1 Diabetes Mellitus.
  • 3.FBS more than 250 mg/dl and PPBS more than 350 mg/dl.
  • 4.Patients of Type-2 diabetes mellitus who are on insulin therapy and Drug induced diabetes mellitus.
  • 5.Type-2 diabetes mellitus with complications and Madhumeha with Ashadhya upadrava 6.History of hypersensitivity or allergy to study drugs 7.Uncontrolled hypertension (systolic blood pressure more than 180 mmHg or diastolic blood pressure more than 100 mmHg) 8.Presence of any other serious medical condition that may interfere with study participation.

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Shalini

National Institute of Ayurveda, Deemed to be university, Jaipur

研究点 (1)

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