A Double Blind, Prospective, Randomised, Four Arm Clinical Study to Evaluate the Safety, Efficacy and Tolerability of Two Doses of Collagen Peptide in Comparison with Resistant Dextrin as a Nutraceutical 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: 2021年11月24日

试验速览

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•1.Male and female adults between the ages of 21 and 50 years (both ages inclusive).
•2.Subjects with known history/diagnosis of diabetes mellitus (type II).
•3.Subjects who are on standard therapy of Sitagliptin for management 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 normal presentations during physical examination and laboratory investigations â?? complete blood count and serum biochemistry

•1.Subjects who are vegetarians or vegans 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, anti-psychotics.
•6.Subjects who have no modified their dosage of standard therapy within one month of randomisation.
•7.Subjects who 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.

发起方

itta Gelatin India Limited