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临床试验/CTRI/2015/02/005518
CTRI/2015/02/005518已完成未知

A Double Blind, Prospective, Randomised, Comparative, Active Controlled, Two Arm, Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Collagen Peptide as an Add-On Nutritional Therapy in the Management of Diabetes Mellitus (Type II) in Adult Subjects.

itta Gelatin India Limited0 个研究点目标入组 60 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
已完成
发起方
入组人数
60

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1.Male and female adults between the ages of 21 and 50 years (both ages inclusive).
  • 2.Subjects with known history of diabetes mellitus (type II).
  • 3.Subjects who are on oral hypoglycaemic agents for control of diabetes mellitus (type II).
  • 4.Subjects who have no known history or diagnosis of complications association with diabetes mellitus (type II).
  • 5.Subjects who are non-alcoholic and non-smokers/non-users of tobacco.
  • 6.Subjects with Body Mass Index between 18 to 32 kg/m2 , both values inclusive.
  • 7.Subjects with clinically normal presentations during physical examination and laboratory investigations â?? complete blood count and serum biochemistry.

排除标准

  • 1.Subjects who are vegetarians or vegans or those who object to consumption of animal origin products.
  • 2.Subjects on herbal, ayurvedic, homeopathic medications for the control of diabetes mellitus.
  • 3.Subjects with known history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases.
  • 4.Subjects who have undergone major surgical procedure 4 weeks prior to randomisation.
  • 5.Subjects who are on steroids, hormone therapy, anti-depressants and anti-psychotics.
  • 6.Subjects who have modified their dosage of primary therapy within one month prior to randomisation.
  • 7.Subjects who are mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
  • 8.Subjects who are known/reported to be pregnant, lactating, planning a pregnancy or unwilling to practice double barrier contraceptive method.
  • 9.Subjects who in the opinion of the investigator are deemed unfit to participate in the study.

研究者

发起方
itta Gelatin India Limited

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