A prospective, open label, single arm, multi-centric study to evaluate the safety and efficacy of Nutricharge Glycem Tablet administered with Nutricharge Glycem Prodiet of Trophic Wellness Pvt. Ltd., India in Pre-diabetic subjects.

Trophic Wellness Private Limited0 个研究点目标入组 0 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)Willing and able to understand and provide written informed consent.
•2) Male or Female aged 18 years and older
•3) Random blood glucose level between 140 to 200mg/dL
•4) Eligible participants must not be diagnosed with Type 1 or Type 2 diabetes
•5) Being mentally competent and able to understand all study requirements.
•6) General medical condition does not interfere with trial procedures (at investigator discretion)
•7) Females are eligible if:
•A. They do not plan to become pregnant during the study
•B. Negative screening pregnancy test
•C. Sexually active women, unless surgically sterile or post menopausal, must use one of the following methods to avoid pregnancy during the study: 1. Abstinence from penile/vaginal intercourse during the study; 2. Double barrier contraceptive methods 1 of which must be condom.

•1. Known hypersensitivity to the Investigational Product
•2. Lactose intolerance
•3. Unable to perform low impact physical activity, such as being chair-bound or
•having low mobility;
•4. Being unable to chew and digest food normally and to eat a balanced diet
•(e.g. any digestive disease)
•5. Type 1 and Type 2 Diabetic patients
•6. Subjects taking Hypoglycaemic medication/s
•7. Subjects positive for hepatitis B, Hepatitis C, HIV 1 & 2, VDRL or active
•autoimmune disorders.
•8. In subjects with hepatic impairment. Having clinically significant ALT. AST
•bilirubin levels at screening.
•9. Serious underlying diseases or disorder and complications that may interfere
•for assessment of the efficacy and safety of the Investigational Productas perthe discretion of the Investigator.
•10. Any clinically significant abnormal laboratory parameter evaluated duringscreening.
•11. Current use of nutritional supplements and or medical foods within 30 daysprior to the beginning of the study and for the duration of the study.
•12. Use of prescription medications and/or nonprescription medications for acutemedical conditions, semi-acute medical conditions and weight loss.
•13. Female subjects who are currently pregnant and/or breast feeding.

发起方

Trophic Wellness Private Limited