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

Phase

N/A

Condition

Anemia

Treatment

Minayo Yeast Drink Product

Clinical Study ID

NCT06066151

23-RD-09-MY-001

Ages 18-35
Female
Accepts Healthy Volunteers

Study Summary

The goal of this single arm, open-label study is to learn about the efficacy of Minayo Iron-rich Yeast Drink with SOD on females who are aged 18-35 and suffer nutritional Anemia, skin condition and Qi-blood deficiency syndrome. The main question it aims to answer is:

whether the serum ferritin level in blood is improved after the intervention

14 qualified participants will be enrolled to drink the product "Minayo Iron-rich Yeast Drink with SOD" for four weeks, once a day. Four site visits will be made for each participant so that all relevant clinical data will be captured and recorded for data analysis and reporting.

Researchers will compare the final blood test result (hemoglobin concentration level, Glutathione (GSH), Superoxide Dismutase (SOD)) against the baseline to conclude whether the product will be effective in improving Anemia and skin conditions.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Female, aged 18 to 35;
Hemoglobin concentration level below 110g/L based on WHO diagnostic criteria foranemia;
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 thetrial;
Willing to refrain from participating in other interventional clinical studiesduring the trial period;
Be able to fully understand the purpose, benefits and potential risks including sideeffects of the research;
Willing to obey all test requirements and procedures;
Informed consent signed.

Exclusion

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 intestinalfunction, such as history of gastrointestinal resection, colon or rectal cancer,inflammatory bowel disease, diabetes, hyperthyroidism or hypothyroidism, congenitalmegacolon, scleroderma, anorexia nervosa, etc.;
Controlling diet, exercising, or taking medications to control weight or affectappetite in the last 3 months;
Subject who has any of the following medical history or clinical findings that mayaffect 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 maycause bowel dysfunction or can affect test result evaluation;
Frequently use of medications that may affect gastrointestinal function or theimmune system according to investigator's judgment;
Take laxatives or other substances that promote digestion 2 weeks before the trailstart;
Subject who used drugs or supplements of iron agent 10 days before the beginning ofthe 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.

Study Design