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A clinical study on the efficacy of iron gummies in improving anemia and Qi & blood-related symptoms in young womenh: A Double-blinded, Randomized and Controlled Study

A clinical study on the efficacy of iron gummies in improving anemia and Qi & blood-related symptoms in young womenh: A Double-blinded, Randomized and Controlled Study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061345
Enrollment
Unknown
Registered
2022-06-21
Start date
2022-06-08
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Group 1:product intervention
Group 2:product intervention

Sponsors

Hangzhou Xiaoqun Network Technology Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: 1. Male or female subjects, 18 to 35 years old; 2. PI recruited young female volunteers with hemoglobin below 110g/L based on the WHO diagnostic criteria for anemia; 3. During the study, the subjects agree not to take any drugs, supplements, or other dairy products; 4. During the study, the subjects agree not to take any other iron-containing medicines or nutritional supplements; 5. Subjects are willing not to participate in other interventional clinical studies during the study; 6. Subjects can fully understand the nature, purpose, benefits, possible risks, and side effects of the study; 7. Willing to obey all test requirements and procedures; 8. Agreed to sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Subject who is in the treatment of gastrointestinal diseases; 2.Subject who has lactose intolerance; 3.The subjects are currently suffering from other organic diseases that affect intestinal function, such as history of gastrointestinal resection, colonic or rectal cancer, inflammatory bowel disease, diabetes, hyperthyroidism or hypothyroidism, Hirschsprung's disease, scleroderma, anorexia nervosa, etc. 4.In the last 3 months, those who have been controlling diet, strengthening exercise, or taking drugs to control weight or affect appetite; 5.Subjects have any of the following medical histories or clinically diagnosed diseases that may affect the evaluation of the test effect: obvious gastrointestinal dysfunction, liver, kidney, endocrine, blood, respiratory and cardiovascular diseases; 6.Subejects who current or past abuse of alcohol or other prohibited drugs, supplements or OTC prescription drugs may cause intestinal dysfunction or affect the evaluation of the study effect; 7.According to the judgment of the researchers, frequent use of drugs that may affect gastrointestinal function or the immune system; 8.Subjects who took laxatives or other digestive aids 2 weeks before the start of the study; 9.Consumed dairy products or other foods with iron supplementation within 10 days before the start of the study; 10.Pregnant or breastfeeding women, or those planning to become pregnant during the study; 11.PI believes that volunteers cannot fully cooperate with the trial arrangement.

Design outcomes

Primary

MeasureTime frame
Serum ferritin;Serum iron;Total iron binding capacity;Transferrin saturation;Unsaturated iron binding capacity;Blood routine;Blood & Qi analysis;Blood proteomics;Blood metabolomics;Urine metabolomics;Urine routine;Skin moisture measurement;Infrared thermal instrument FLIR;Antera-3D image analysis;

Secondary

MeasureTime frame
Liver and kidney function tests;Anthropometric indicators;72-hour diet review;Weekly exercise review;

Countries

China

Contacts

Public ContactShuguang Li

Fudan School of Public Health

eeshuguang@fudan.edu.cn+86 13701910238

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026