A Phase 2 interventional study of Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA) and Placebo in Diabetes Mellitus, Type 2, sponsored by Al-Mustafa University College. Completed at 1 site in Iraq. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-02.
Sponsored by Al-Mustafa University College · Phase 2, Interventional, and Treatment
The goal of this interventional Randomized clinical is to compare the effect of colostrum pharmaceutical preparation and placebo in a sample of Iraqi participants. The main questions to answer are:
Participants will be separated into four groups:
Researchers will compare Groups 1,2,3, and 4 to observe the effect of the tested treatment regimens on IL-1, IL-6 ,Fasting Blood Glucose, HbA1c, Body Mass Index, Lipid profile, Rate pressure product, C-reactive protein, and Hematological indices. and use these measures In special formulas to determine the effect of the tested regimens on physical performance and cognitive function.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 80 is close to the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Al-Mustafa University College is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
24 Patients receiving Placebo Capsule per oral once daily for 60 days.
Other: Placebo
26 Patients receiving Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA), one capsule per oral once daily for 60 days.
Drug: Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA)
23 Patients receiving Placebo Capsule per oral once daily for 60 days.
Other: Placebo
27 Patients Receiving Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA), one capsule per oral once daily for 60 days.
Drug: Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA)
Brand name: (Colostrum® 500 mg Veg Capsules) capsules per oral / once daily / 60 days duration.
Also known as: Colostrum®
Placebo Capsule / Capsules per oral / once daily / 60 days duration
Serum interleukin-1 (IL-1) Level
Measured in Pg/mL
Time frame: At Baseline, and After 60 days of treatment.
Serum interleukin-15 (IL-15) Level
Measured in Pg/mL
Time frame: At Baseline, and After 60 days of treatment.
Fasting Blood Sugar (FBS)
Measured in mg/dL
Time frame: At Baseline, and After 60 days of treatment.
Hemoglobin A1C (HbA1C)
Measured in percent from total Hemoglobin
Time frame: At Baseline, and After 60 days of treatment.
Body Mass Index (BMI)
Measured in Kg/m²
Time frame: At baseline, and after 60 days of treatment
Serum C-reactive protein (CRP)
Measured in mg/dL
Time frame: At baseline, and after 60 days of treatment
Rate Pressure Product
Measured in an equation combining Heart rate in (BPM) and blood pressure in (mmHg)
Time frame: At baseline, and after 60 days of treatment.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Al-Mustafa University College