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临床试验/CTRI/2024/07/070649
CTRI/2024/07/070649招募中3 期

An empirical study on the effectiveness of individualized homoeopathic management in cases of type-2 diabetes mellitus.

Mayank Kanubhai Roy1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年9月5日最近更新:

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
120
试验地点
1
主要终点
HbA1c change reduced to less than 6.5%.

研究概览

简要总结

AIM: ‘To evaluate the effectiveness of Individualized Homoeopathic

Management in cases of type 2 diabetes mellitus’.

OBJECTIVES:

  1. To assess how The Individualized Management of Type-2 Diabetes

Mellitus patient can create wholistic changes.

  1. To observe and evaluate the changes in the HbA1c as The Individualized

Management works on patients with type 2 diabetes.

H0 – Hypothesis

"There is no significant difference in glycemic control among individuals with

type 2 diabetes mellitus who receive individualized homeopathic management

tailored to their unique symptoms and characteristics."

Ha - Hypothesis

"The application of individualized homeopathic management tailored to the

unique symptoms and characteristics of each patient will lead to significant

improvements in glycemic control in individuals with type 2 diabetes mellitus."

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 58.00 Year(s)(—)
性别
All

入选标准

  • Cases pre-diagnosed or having clinical features of type 2 diabetes mellitus.
  • The patients giving their consent to participate in study with minimum six follow ups.
  • HbA1c level is 6.5% or Above
  • Age- 18 to 58 years and of both sexes.
  • Patients who are not taking any medication.
  • Patients who have stopped medication 3 moths before induction.

排除标准

  • Age below 18 years and above 58 years.
  • Pregnant and lactating patients.
  • Patient with Serious complication with inflammatory changes.
  • Cases with less than 6 follow up.
  • Patient Diagnosed with G6PD deficiency (glucose-6-phosphatedehydrogenase deficiency).
  • Any patient found to be uncooperative during the study.
  • Unable to Speak Gujarati, Hindi or English.

结局指标

主要结局

HbA1c change reduced to less than 6.5%.

时间窗: HbA1c at every 3 months in treatment duration.

次要结局

  • Overall Lifestyle changes(relief in symptoms at every 4 weeks. with changes in FBS & PP2BS at gradual pace.)

研究者

发起方
Mayank Kanubhai Roy
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Mayank Kanubhai Roy

Parul University

研究点 (1)

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