Effect of Hanbencui product on the improvement of female's Qi and blood: a randomized controlled trial

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100046751

Enrollment

Unknown

Registered

2021-05-28

Start date

2021-05-25

Completion date

Unknown

Last updated

2022-01-10

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

Conditions

None listed

Interventions

Experimental group:Intake Hanbencui Product A

Placebo group:Intake Hanbencui Product B

Eligibility

Sex/Gender

Female

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. Female subject aged 18 to 55 years who is perimenopause and has been screened according to the Qi & Blood questionnaire score. 2. Subject who signed the informed consent form. 3. Subject who is able to complete the 12-week clinical study according to the protocol requirements. 4. No pregnant plan during the study. 5. Normal liver and kidney function 6. Subject who does not have losing weight plan (1 hour regular exercise per day or food control or medicine control) during the study.

Exclusion criteria

Exclusion criteria: 1. Subject who has cardiovascular disease, cerebrovascular disease, liver disease, kidney disease, or hematologic disease, IBS, IBD, etc. 2. Subject who has done hand surgery or has suffered serious trauma or has occupational hand-arm vibration disease. 3. Preparation for pregnancy, pregnant or breast feeding woman, or allergic subjects. 4. Subject who has intaken medicine or supplement which can improve the Qi & Blood in the past 1 month so that it will interfere the study result. 5. Subjects enrolled for other clinical studies in the previous three months. 6. The researcher believes that the volunteers cannot fully cooperate with the experiment arrangement.

Design outcomes

Primary

Measure	Time frame
Alanine aminotransferase;Aspartate aminotransferase;Uric acid;Serum ferritin;Serum iron;Total iron binding capacity;Transferrin saturation;Free erythrocyte protoporphyrin;Blood routine;Blood gas analysis;Blood proteomics;Blood metabolomics;Urine metabolomics;Urine routine;Qi & Blood health questionnaire;Fatigue scale;	—

Secondary

Measure	Time frame
Skin moisture measurement;VISIA CR image analysis;Infrared thermal instrument FLIR hand temperature measurement;PeriCam PSI measures blood perfusion;Anthropometric indicators;72-hour diet review;Weekly exercise review;	—

Countries

China

Contacts

Public ContactWang Ji

Beijing University of Chinese Medicine

15201129912@126.com+86 15201129912

Outcome results