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临床试验/CTRI/2026/02/103985
CTRI/2026/02/103985尚未招募2 期

A Clinical Study to evaluate the therapeutic effect of Gayatryadi Kashaya in Prediabetes

Dr Tony Thomas Manamel2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年3月10日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
120
试验地点
2

研究概览

简要总结

This is a prospective, randomized, open-label, parallel arm interventional clinical study designed to evaluate the therapeutic effect of Gayatryadi Kashaya  in patients with prediabetes.

The study will be conducted in India over a total duration of 4 months, including a 3-month intervention period. A total of 120 patients will be enrolled and randomly allocated into two groups:

  1. Intervention group – receiving Gayatryadi Kashaya 15 mL twice daily added with 30 ml water, with Anupana of Honey 5ml before food.
  2. Control group – receiving Honey 5ml BD with 30 ml water before food.

Primary Outcome Measures:

  • Fasting Blood Sugar (FBS)
  • Postprandial Blood Sugar (PPBS)
  • Urine routine examination

These will be assessed on Day 0 (baseline), Day 30, Day 60, Day 90, and Day 120.

Secondary Outcome Measures:

  • Fasting lipid profile
  • HbA1c

These will be assessed on Day 0 (baseline) and Day 120.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 55.00 Year(s)(—)

入选标准

  • Patients fulfilling the diagnostic criteria.
  • between 18 years to 55 years.

排除标准

  • Diabetes Mellitus (Type-1&2).
  • Patients of age group less than 18 and more than 55 years.
  • Any associated Systemic disorder that will interfere with present treatment.
  • Patients associated with renal, cardiac, and other complication.
  • Pregnant and lactating women.

研究者

发起方
Dr Tony Thomas Manamel
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Tony Thomas Manamel

Department of Kayachikitsa

研究点 (2)

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