AnemiaNCT06869824
The Efficacy of Minayo Iron-rich Nutritional Gummies on Female Anemia, Skin Condition and Qi-blood Deficiency Syndrome
A study testing Minayo Iron-rich Nutritional Gummies and Common Gummies in people with Anemia and Skin Condition, run by Hangzhou Agile Groups Network Technology Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anemia, Skin Condition, Qi-blood Deficiency Syndrome
- What is being tested?
- Minayo Iron-rich Nutritional Gummies and Common Gummies
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 17 Mar 2025to 13 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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 locations and contacts
1 site in 1 country.
About this study
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
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
Read more
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.
- Conditions
- Anemia, Skin Condition, Qi-blood Deficiency Syndrome
- Being tested
- Minayo Iron-rich Nutritional Gummies, Common Gummies
- Keywords
- Minayo, Iron-rich Nutritional Gummies, Serum ferritin, Hemoglobin
- Medical subject headings
- Anemia, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minayo Iron-rich Nutritional GummiesDietary supplement
Participants need to eat one piece of the assigned product after meal three times a day, for 4 consecutive weeks.
Common GummiesDietary supplement
Participants need to eat one piece of the assigned product after meal three times a day, for 4 consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Minayo Iron-rich Nutritional Gummies | Active comparator | 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 .. Receives: Dietary Supplement: Minayo Iron-rich Nutritional Gummies |
| Common Gummies | Placebo comparator | common gummies with main ingredient - Maltodextrin, 3g/piece Receives: Dietary Supplement: Common Gummies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Serum Ferritin Level
The change of serum ferritin level in blood, ng/mL (12~135ng/mL for healthy female, 27~375ng/mL for healthy male)
Measured: baseline day, end of week 4
Change of Hemoglobin Concentration Level
The change of hemoglobin concentration level in blood, g/L (115-150g/L)
Measured: baseline day, end of week 4
Secondary outcomes (2)
Facial image capturing and analysis
The facial images capturing and analysis by VISIA-CR® imaging system, the degree of facial ruddiness/redness, number of wrinkle lines
Measured: baseline day, end of week 4
Change of hand temperature
The change of hand temperature in celsius degree measured by FLIR E60 thermal imaging camera
Measured: baseline day, end of week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start17 Mar 2025
- Primary completion13 Apr 2025
- Study completion13 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hangzhou Agile Groups Network Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charlie Zhang, MD, Principal investigator, Raison Biotech Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06869824
- Sponsor's protocol ID
- 25-RD-01-MY-001
- Status last verified
- Jul 2025
- First submitted
- 5 Mar 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06869824
- Acronym / sponsor ID
- 25-RD-01-MY-001
- Conditions
- Anemia, Skin Condition, Qi-blood Deficiency Syndrome
- Keywords
- Minayo, Iron-rich Nutritional Gummies, Serum ferritin, Hemoglobin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hangzhou Agile Groups Network Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 13 Apr 2025 (actual)
- Study completion
- 13 Apr 2025 (actual)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minayo Iron-rich Nutritional Gummies | Active comparator | Dietary Supplement: Minayo Iron-rich Nutritional GummiesMinayo 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 .. |
| Common Gummies | Placebo comparator | Dietary Supplement: Common Gummiescommon gummies with main ingredient - Maltodextrin, 3g/piece |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minayo Iron-rich Nutritional GummiesParticipants need to eat one piece of the assigned product after meal three times a day, for 4 consecutive weeks. | Dietary supplement | Minayo Iron-rich Nutritional Gummies |
| Common GummiesParticipants need to eat one piece of the assigned product after meal three times a day, for 4 consecutive weeks. | Dietary supplement | Common Gummies |
Primary outcome
Change of Serum Ferritin Level
Time frame: baseline day, end of week 4
The change of serum ferritin level in blood, ng/mL (12~135ng/mL for healthy female, 27~375ng/mL for healthy male)
Change of Hemoglobin Concentration Level
Time frame: baseline day, end of week 4
The change of hemoglobin concentration level in blood, g/L (115-150g/L)
2 secondary outcomes
Facial image capturing and analysis
Time frame: baseline day, end of week 4
Change of hand temperature
Time frame: baseline day, end of week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlie Zhang, MD principal investigator
Raison Biotech Co., Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minayo Iron-rich Nutritional Gummies and Common Gummies in people with Anemia and Skin Condition, run by Hangzhou Agile Groups Network Technology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Serum Ferritin Level (time frame: baseline day, end of week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.