The Efficacy of Minayo Iron-rich Yeast Drink With SOD on Female Nutritional Anemia, Skin Condition and Qi-blood Deficiency Syndrome

Launched by HANGZHOU AGILE GROUPS NETWORK TECHNOLOGY CO., LTD. · Sep 27, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a product called Minayo Iron-rich Yeast Drink with SOD to see if it can help improve nutritional anemia, skin conditions, and a specific health issue known as Qi-blood deficiency syndrome in women aged 18 to 35. The main focus is to check if taking this drink for four weeks can increase the levels of ferritin, a protein that helps store iron in the blood, which is important for overall health. In total, 14 women who meet certain health criteria will participate in the study, and they will have to visit the research site four times to have their blood tested and monitored.

To be eligible for this trial, participants must be females aged 18 to 35 with low hemoglobin levels, which is a sign of anemia. They need to agree not to take any other iron supplements or medications during the study. Participants can expect to drink the Minayo drink once a day for four weeks and then undergo blood tests to see if their health has improved. It’s essential for participants to understand the study's purpose and agree to follow all the guidelines set by the researchers.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Female, aged 18 to 35;
• • Hemoglobin concentration level below 110g/L based on WHO diagnostic criteria for anemia;
• • Agree not to take any drugs, supplements, or other dairy products during the trial;
• • Agree not to take any other medications or supplements containing iron during the trial;
• • Willing to refrain from participating in other interventional clinical studies during the trial period;
• • Be able to fully understand the purpose, benefits and potential risks including side effects of the research;
• • Willing to obey all test requirements and procedures;
• • Informed consent signed.
• Exclusion Criteria:
• • Anemia caused by organic diseases;
• • Subject who is in the treatment of gastrointestinal symptoms;
• • Lactose intolerance;
• • Subject who is currently presence of other organic diseases affecting intestinal function, such as history of gastrointestinal resection, colon or rectal cancer, inflammatory bowel disease, diabetes, hyperthyroidism or hypothyroidism, congenital megacolon, scleroderma, anorexia nervosa, etc.;
• • Controlling diet, exercising, or taking medications to control weight or affect appetite in the last 3 months;
• • Subject who has any of the following medical history or clinical findings that may affect the evaluation of the trial effect: significant gastrointestinal disorders, liver, kidney, endocrine, hematological, respiratory and cardiovascular diseases;
• • Abuse alcohol or other drugs, supplement or OTC drugs currently or n the past may cause bowel dysfunction or can affect test result evaluation;
• • Frequently use of medications that may affect gastrointestinal function or the immune system according to investigator's judgment;
• • Take laxatives or other substances that promote digestion 2 weeks before the trail start;
• • Subject who used drugs or supplements of iron agent 10 days before the beginning of the trial;
• • Pregnant or lactating women or those planning to become pregnant during the trial;
• • PI deems that subjects could not fully cooperate with trial arrangements.