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Real-world study on ARBP-001 (Arura Tibetan Medicine Special Pellets) for regulating immune function and improving fatigue symptoms

Real-world study on ARBP-001 (Arura Tibetan Medicine Special Pellets) for regulating immune function and improving fatigue symptoms

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002073
Enrollment
Unknown
Registered
2025-10-28
Start date
2025-11-01
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Decrease in immune function with Qi deficiency or Qi-yin deficiency

Interventions

Intervention group:ARBP-001 (Arura Tibetan Medicine Special Pellets) Trial for 3 Months

Sponsors

School of Public Health, Medical School of Shenzhen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 74 Years

Inclusion criteria

Inclusion criteria: (1) Age between 45 and 74 (inclusive), no gender restrictions; (2) Meet the TCM diagnostic criteria for Qi deficiency, or Qi-Yin dual deficiency syndrome; (3) The comprehensive evaluation score of the immune-related health score =60; (4) Willing to take ARBP-001 (Arura Tibetan Medicine Special Pellets) for 3 months.

Exclusion criteria

Exclusion criteria: (1) Pregnant or preparing for pregnancy women and lactating women. (2) Patients with severe diseases of the heart, brain, liver, kidney, hematopoietic system, or mental illnesses. (3) Individuals diagnosed with uncontrolled blood sugar levels (the product contains processed honey and honey). (4) Individuals who have taken or plan to take medications or foods related to the tested function within one month before screening, which may affect the evaluation of results. (5) Individuals known to be allergic to any component of the product. (6) Individuals who do not understand the questionnaire, cannot complete self-assessment, or cannot clearly express their symptoms.

Design outcomes

Primary

MeasureTime frame
TCM Syndrome Score Table (Qi Deficiency or Qi-Yin Deficiency TCM Syndrome Score);Immune-Related Health Score;Multidimensional Fatigue Inventory (MFI-20) ;Immunoglobulins and Complements: IgA, IgG, IgM, IgE, C3, C4;Lymphocyte subset (T/B/NK) test: CD3+, CD4+, CD8+, NK cells;Oxidative stress indicators: malondialdehyde (MDA), superoxide dismutase (SOD), glutathione peroxidase (GPx) levels;—

Secondary

MeasureTime frame
Pittsburgh Sleep Quality Index (PSQI) Score;Physical Fitness Assessment Questionnaire;White blood cell count;—

Countries

China

Contacts

Public ContactHu Dongsheng

School of Public Health, Health Science Center, Shenzhen University

hud@szu.edu.cn+86 755 8667 1951

Outcome results

None listed

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