跳至主要内容
临床试验/CTRI/2025/03/082562
CTRI/2025/03/082562尚未招募Phase 3 4

A COMPARATIVE TRIAL TO EVALUATE THE EFFECT OF VIDANGA CHOORNA AND TAKRA WITH SELECTED DIETARY MODIFICATIONS IN PREDIABETES

GEETHU PRAKASH M1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2025年4月10日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
66
试验地点
1
主要终点
Changes in FBS, PPBS, HbA1C

研究概览

简要总结

Prediabetes is a salient state of Hyperglycaemia or Hyperinsulinaemia that often precedes a diagnosis of Type 2 diabetes (T2DM ). It is projected that by 2040, almost 8% of the global population will have prediabetes, with approximately 70% progressing to T2DM within their lifetime.1 Although at present prediabetes is considered as mild disease, the shift towards acceptance as an independent pathological entity is supported by inclusion in the 2015 International Statistical Classification of Diseases and Related Health Problems (ICD).This inclusion is important for public perception as it conveys the medically supported need for treatment or intervention.

According to Ayurveda Vidanga choorna with Takra is explained in the Vaidhya Manorama in Prameha chiktsa. The objective of the study is to find out the effect of Vidanga choorna with Takra in Prediabetic population in achieving glycemic control. 66 participants irrespective of gender in the age group of 35-60 years with FBS value 100-125mg/dl, PPBS value 140-199 mg/dl and HbA1C value 5.7-6.4% are selected for this Quasi Experimental study from the OPD of Swasthavritta, Govt.Ayurveda college, Thiruvananthapuram and are consecutively allocated into 2 groups, namely study group and control group. The participants in the study group will be instructed to take 6gm of Vidanga choorna along with 100 ml of Takra in two divided dose along with Dietary Modifications while the control group will be instructed to follow Dietary Modifications only . The study period is 90days.The outcome measurements will be analysed through blood investigations of FBS, PPBS, 0th day, 31st ,61st and 91st day and HbA1c on 0th day and 91st day.

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
35.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Participants irrespective of gender 2)Participants in the age group of 35-60 yrs 3)Having FBS value between 100-125mg/dl Either any of these; 4)PPBS Value between 140-199mg/dl 5)Having HbA1C value between 5.7-6.4%.

排除标准

  • Diagnosed case of PCOS under medications 2)Pregnant ladies and lactating women 3)Malignancy 4)Diagnosed cases of other endocrine disorders and thyroid problems 5)Any chronic systemic disorders.

结局指标

主要结局

Changes in FBS, PPBS, HbA1C

时间窗: FBS -0th,31st,61st and 91st day | PPBS-0th,31st,61st and 91st | day | HbA1C - 0th and 91st day

次要结局

未报告次要终点

研究者

发起方
GEETHU PRAKASH M
申办方类型
Other [SELF ]
责任方
Principal Investigator
主要研究者

GEETHU PRAKASH M

GOVERNMENT AYURVEDA COLLEGE THIRUVANANTHAPURAM

研究点 (1)

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