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临床试验/CTRI/2025/03/082894
CTRI/2025/03/082894招募中2 期

A Study To assess The Effect Of Camel Milk Powder as an adjuvant therapy on serum insulin level of Type 2 Diabetic Patients Visiting A Tertiary Care Hospital Located In Rural Vadodara, Gujarat

Vedika Walia1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年5月3日最近更新:

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
serum insulin and FBS will be estimated

研究概览

简要总结

This study is a randomised controlled trial wherein 80 type 2 diabetes mellitus subjects will be enrolled for the study. 20 grams camel milk powder will be given daily for the period of 45 days. The study will be conducted in tertiary care hospital in Vadodara, Gujarat, India. The primary outcome measures will be  FBS and serum insulin levels after 45 days.

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
35.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • 1.Age more than or equal to 35 years of age, HbA1c more than or equal to 6.5 with T2DM 2.oral hypoglycemic agents – biguanide (metformin), alpha glucosidase inhibitor (AGI), dipeptidyl peptidase-4 (DPP4) inhibitors and diuretics.
  • 3.Willingness to abstain from intake of other milk and milk products during the study.
  • 4.Agree to take camel milk as part of study during the study period.
  • 5.Willing to participate in the study.

排除标准

  • 1.Diabetic subjects taking insulin and with diabetic complications such as nephropathy, neuropathy or cardiovascular disease.
  • 2.oral hypoglycemic agents – sulphonylureas, SGLT2 and steroids.
  • 3.pregnant or lactating women.
  • 4.Person having Intolerance to camel milk.

结局指标

主要结局

serum insulin and FBS will be estimated

时间窗: 45 days

次要结局

  • body composition(45 days)

研究者

发起方
Vedika Walia
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Vedika Walia

Sumandeep Vidyapeeth deemed to be university

研究点 (1)

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