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临床试验/CTRI/2024/04/065878
CTRI/2024/04/065878尚未招募3 期

Efficacy of Haritaki churna in Prediabetes-A Double-Blind Randomized Controlled Clinical Trial

Dr Patil Shraddha Anilrao1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年7月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
changes in Levels of HbA1c, FBS PPBS

研究概览

简要总结

A randomized,double blind control clinical , parallel group, single center triall comparing efficacy of capsule Haritaki churna 1.5gms twice a day with warm water and capsule haridra churna 1.5gms twice a day with warm water daily for 90 days in 40 patients with Prediabetes will be conducted in KAHERS SHRI BMK AYURVEDA MAHAVIDYALAYA AND RESEARCH CENTRE Shahapur Belagavi Karnataka. The primary outcome will be haritaki churna may help in level of HbA1c, FBS and PPBS of prediabetic subjects and help in improving the QOL.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

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

入选标准

  • Individuals of HbA1c level between 5.7 to 6.4%.

排除标准

  • 1.Prediabetes with other systemic conditions like thyroid dysfunction, uncontrolled hypertension with or without medication (more than or equal to 140/90 mmHg).
  • 2.Pregnant and lactating women.
  • 3.Individuals on medication for longer period like glucocorticosteroids, thyroid hormones, pentamidine, nicotinic acid, antipsychotics, thiazides, β-adrenergic agonists.

结局指标

主要结局

changes in Levels of HbA1c, FBS PPBS

时间窗: subjective parameters will be assessed on | baseline on 0th 30th 60th 90th, day of the intervention.

次要结局

  • Improvement in QOL(subjective parameters will be assessed on)

研究者

发起方
Dr Patil Shraddha Anilrao
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Patil Shraddha Anilrao

KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya And Research Centre Belagavi

研究点 (1)

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