The Efficacy of Minayo Iron-rich Yeast Drink With SOD on Female Nutritional Anemia, Skin Condition and Qi-blood Deficiency Syndrome
A Single Arm, Open-label Study of the Efficacy of Minayo Iron-rich Yeast Drink With SOD on Female Nutritional Anemia, Skin Condition and Qi-blood Deficiency Syndrome
1 other identifier
interventional
11
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 10, 2023
CompletedFirst Submitted
Initial submission to the registry
September 27, 2023
CompletedFirst Posted
Study publicly available on registry
October 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 9, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2023
CompletedSeptember 15, 2025
September 1, 2025
29 days
September 27, 2023
September 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
baseline day, end of week 4
Secondary Outcomes (4)
Hemoglobin Concentration Level
baseline day, end of week 4
Superoxide Dismutase (SOD) Concentration Level
baseline day, end of week 4
Glutathione (GSH) Concentration Level
baseline day, end of week 4
Skincare Measurement - Lines/Wrinkles
baseline day, end of week 4
Study Arms (1)
Minayo Yeast Drink Product
EXPERIMENTALMinayo Iron-rich Yeast Drink with SOD, 385 pieces, 25ml/piece, each piece contains 13mg of iron. Main ingredients: Water, erythritol, jujube juice concentrate, Wolfberry juice concentrate, ferrous gluconate, olive powder, SOD yeast powder, yeast extract (including glutathione), artichoke, etc.
Interventions
Participants need to drink one piece of the products each day, for 4 consecutive weeks.
Eligibility Criteria
You may qualify if:
- Female, aged 18 to 35;
- Hemoglobin concentration level below 110g/L based on WHO diagnostic criteria for anemia;
- 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 the trial;
- Willing to refrain from participating in other interventional clinical studies during the trial period;
- Be able to fully understand the purpose, benefits and potential risks including side effects of the research;
- Willing to obey all test requirements and procedures;
- Informed consent signed.
You may not qualify if:
- 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 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 n 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Raison CMA Lab
Shanghai, Shanghai Municipality, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charlie Zhang, MD
Raison Biotech Co., Ltd.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2023
First Posted
October 4, 2023
Study Start
September 10, 2023
Primary Completion
October 9, 2023
Study Completion
December 15, 2023
Last Updated
September 15, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share