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

Not Applicable

• Conditions: Decrease in immune function

• Registration Number: ITMCTR2200005584
• Lead Sponsor: Xiyuan Hospital ,China Academy of Chinese Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

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

(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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptom Score scale;the MOS item short from health survey, SF-36;

Secondary Outcome Measures

Name	Time	Method
Humoral immunity 7;T cell subsets;