Efficacy of Iron-rich Gummies for Female Anemia and Skin Conditions

A Randomized, Double-blind, Placebo-controlled Trial of the Efficacy of Minayo Iron-rich Nutritional Gummies on Female Anemia, Skin Condition and Qi-blood Deficiency Syndrome

This study is testing if iron-rich gummies can help women aged 18-45 with mild anemia and skin issues feel better over four weeks.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Female
• Sponsor: Hangzhou Agile Groups Network Technology Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT06869824 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, placebo-controlled study aims to evaluate the effectiveness of Minayo Iron-rich Nutritional Gummies in improving anemia, skin conditions, and Qi-blood deficiency syndrome in females aged 18-45. A total of 36 participants with mild anemia will be enrolled and divided into two groups, one receiving the gummies and the other a placebo. The study will last for 4 weeks, with three site visits to collect clinical data for statistical analysis. The primary outcome will be measured through serum ferritin levels and hemoglobin concentration in the blood.

Who should consider this trial

Good fit: Ideal candidates are females aged 18 to 45 with mild anemia and no underlying organic causes for their condition.

Not a fit: Patients with anemia due to organic conditions or those currently undergoing treatment for gastrointestinal symptoms may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide an effective nutritional intervention for women suffering from anemia and related conditions.

How similar studies have performed: While similar nutritional interventions have shown promise, this specific approach using Minayo Iron-rich Gummies is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* Female subjects, aged 18 to 45;
* 36 young women with mild anemia (hemoglobin value between 90-110 g/l) were recruited based on WHO diagnostic criteria for anemia. 10 of the subjects always have coffee and milk tea more than once per day;
* Participants agree not to take any drugs, supplements, or other dairy products during the trial;
* Participants agree not to take any other medications or supplements containing iron during the trial;
* Antibiotics may be used unless medically required, but the type and dosage and days taken should be recorded;
* Willing to refrain from participating in other interventional clinical studies during the trial period;
* Fully understand the nature, purpose, benefits and possible risks and side effects of the study;
* Willing to obey all test requirements and procedures;
* Sign informed consent form.

Exclusion Criteria:

* Anemia due to organic conditions;
* 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 in 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.

Where this trial is running

Shanghai, Shanghai

• Shanghai Raison CMA Lab — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Charlie Zhang, MD — Raison Biotech Co., Ltd

Conditions Anemia; Skin Condition; Qi-blood Deficiency Syndrome; Minayo; Iron-rich Nutritional Gummies; Serum ferritin; Hemoglobin