Clinical trial NCT06869824: The Efficacy of Minayo Iron-rich Nutritional Gummies on Female Anemia, Skin Condition and Qi-blood Deficiency Syndrome
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anemia
Skin Condition
Qi-blood Deficiency Syndrome
Keywords: Minayo
Iron-rich Nutritional Gummies
Serum ferritin
Hemoglobin
Lead sponsor: Hangzhou Agile Groups Network Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-03-11
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


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.

Primary outcomes:
measure: Change of Serum Ferritin Level
timeFrame: baseline day, end of week 4
measure: Change of Hemoglobin Concentration Level
timeFrame: baseline day, end of week 4
Secondary outcomes:
measure: Facial image capturing and analysis
timeFrame: baseline day, end of week 4
measure: Change of hand temperature
timeFrame: baseline day, end of week 4
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Raison CMA Lab
state: Shanghai
Study officials:
affiliation: Raison Biotech Co., Ltd
name: Charlie Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: