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Randomized, double-blind, placebo-controlled, multicenter clinical study of Bazi Bushen Capsules in anti-aging.

Randomized, double-blind, placebo-controlled, multicenter clinical study of Bazi Bushen Capsules in anti-aging.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200005803
Enrollment
Unknown
Registered
2022-04-04
Start date
2022-04-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Kidney-essence deficiency patients, premature aging population

Interventions

control group:Bazi Bushen capsule placebo
therapy group:Bazi Bushen Capsule

Sponsors

Xiyuan Hospital, Chinese Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of traditional Chinese medicine for kidney-essence deficiency syndrome; 2. The performance score of the core symptom aging evaluation scale of TCM kidney-essence deficiency syndrome =10 points; 3. Age =30 years old and =80 years old, male or female; 4. Voluntarily participate in this study and sign the written informed consent.

Exclusion criteria

Exclusion criteria: Overall Exclusion Criteria: 1. Those with severe disease or unstable disease state caused by age-related changes of important organs; 2. Patients with severe liver and kidney insufficiency, malignant tumors, blood diseases and other system diseases such as circulation, respiration, nerve (moderate and severe PD/AD); 3. Those with severe mental illness or cognitive dysfunction; 4. Persons with physical disabilities; 5. Those who meet the diagnostic criteria of liver-yang hyperactivity syndrome, excess heat syndrome, damp-heat syndrome, and internal heat syndrome due to yin deficiency, or those who normally meet the above constitutions; 6. Screen patients with a history of alcohol or drug abuse within 1 year before enrollment; 7. Screen those who participated in clinical trials of other drugs within 1 month before enrollment; 8. Known or suspected to have a history of allergy or allergic constitution to the test drug and its excipients; 9. Pregnant or breastfeeding female patients; 10. Patients deemed unsuitable for participation in the study by the investigator due to possible violation of the trial protocol or any other circumstances affecting its safety.

Design outcomes

Primary

MeasureTime frame
Changes in Chinese version of Tilburg Frailty Assessment Scale (TFI) scores after 12 weeks of treatment;Changes in the core symptom aging evaluation scale of traditional Chinese medicine kidney-essence deficiency syndrome after 12 weeks of treatment;

Secondary

MeasureTime frame
5 sitting times, 6-minute walking distance, etc;scalp;Motor function test;skin;Hair;Computer face recognition age;Serum sex hormone level and other indicators;Quality of life rating scale (SF-36);Peripheral blood aging markers;

Countries

China

Contacts

Public ContactFengqin Xu
ylm322@126.com18800021979

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026