The Efficacy of Minayo Iron-rich Nutritional Gummies on Female Anemia, Skin Condition and Qi-blood Deficiency Syndrome

Hangzhou Agile Groups Network Technology

Status: Completed

Conditions: Anemia; Skin Condition; Qi-blood Deficiency Syndrome

Treatments: Dietary Supplement: Common Gummies; Dietary Supplement: Minayo Iron-rich Nutritional Gummies

Study type: Interventional

Funder types: Industry

Identifiers

NCT06869824

25-RD-01-MY-001

Details and patient eligibility

About

The goal of this randomized, double-blind, placebo controlled study is to learn about the efficacy of Minayo Iron-rich Nutritional Gummies on females who are aged 18-45 and suffer nutritional Anemia, skin condition and Qi-blood deficiency syndrome. The main question it aims to answer is:

• whether the Anemia (measured by serum ferritin level and hemoglobin concentration Level in blood) is improved after the intervention

36 qualified participants will be enrolled and assigned to two equal-size groups with study product (Minayo Iron-rich Nutritional Gummies) and placebo product (common gummies) in one study center in Shanghai. The study will last 4 weeks and three site visits will be made, during which all clinical data will be captured and entered to EDC system for statistical analysis and reporting.

Researchers will find out whether the study product (Minayo Iron-rich Nutritional Gummies) is effective to improve Anemia, skin conditions, and Qi-blood deficiency symptoms by comparing the two groups.

Enrollment: 36 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 2 patient groups, including a placebo group

Minayo Iron-rich Nutritional Gummies

Active Comparator group

Description:

Minayo Iron-rich Nutritional Gummies, 3g/piece, each piece contains 7mg of iron. Main ingredients: Maltitol liquid, isomaltitol, erythritol, gelatin, ferrous gluconate, ferrous fumarate, ferric ammonium citrate, acerola cherry powder, cranberry powder, red beetroot powder, raspberry powder, acai powder, salmon hydrolyzed protein peptides, blood protein polypeptides, albumin peptides, Vitamin B1, Vitamin B2, Vitamin B6, Vitamin C, α-cyclodextrin, purple carrot concentrated juice, grape skin extract, agar, citric acid, DL-malic acid, natural food flavoring, octane, glyceryl caprate, and carnauba wax ..

Treatment:

Dietary Supplement: Minayo Iron-rich Nutritional Gummies

Common Gummies

Placebo Comparator group

Description:

common gummies with main ingredient - Maltodextrin, 3g/piece

Treatment:

Dietary Supplement: Common Gummies