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Human feeding trial of enhancing immunity function with INFINITUS Zhenyuan capsule (Syndrome of dual deficiency of spleen and kidney)

Research on the evaluation technology system of TCM compound health care products based on syndrome differentiation and establishment of demonstration r&d platform

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200005584
Enrollment
Unknown
Registered
2022-02-01
Start date
2022-02-14
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

Decrease in immune function

Interventions

Placebo group:Take placebo orally, 3 capsules, twice a day, for 12 weeks
Experimental group:Take Zhenyuan capsule orally, 3 capsules, twice a day, for 12 weeks

Sponsors

Xiyuan Hospital ,China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) 18-65 years old. (2) Persons with weak constitution and easy to get sick (1 of them can be satisfied) ? =5 common colds per year; ? acute trachea-bronchitis/pneumonia caused by infection =2 times per year (except bronchitis/pneumonia caused by infectious disease); ? =5 episodes of acute diarrhoea per year (excluding diarrhoea caused by food intolerance). (3)Meet the standard of spleen and kidney deficiency syndrome of TCM Primary symptom: fatigue, waist knee acerbity. Secondary symptoms: shortness of breath, lazy speech, loose stools ? hair loss, forgetfulness, loss of sexual desire; the pale tongue or The tongue is pale and fat with teeth marks, thin white moss, slow or weak pulse. Two primary symptomsor one main syndrome plus each one of secondary syndrome ? and ?, combined with tongue and pulse can be determined as deficiency of spleen and kidney syndrome. (4)Voluntarily sign informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients with immune-related diseases and tumors. (2) Decreased immune function caused by taking drugs. (3) Allergic to multiple drugs or the known components of the study product. (4) The couple who have pregnancy plan within half a year, pregnancy or breast-feeding women. (5) Patients with serious diseases of heart, brain, liver, kidney and hematopoietic system, serious occupational diseases and mental diseases. (6) Taking drugs, nutrients, probiotics and tonic Chinese medicines which affecting immune function 4 weeks before the start of the trial will affect the judgment of the results.

Design outcomes

Primary

MeasureTime frame
Symptom Score scale;the MOS item short from health survey, SF-36;

Secondary

MeasureTime frame
Humoral immunity 7;T cell subsets;

Countries

China

Contacts

Public ContactKou Qiuai
kouqiuai@163.com13910527397

Outcome results

None listed

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