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Clinical study on the treatment of accumulated heat in stomach and intestine and prevention of respiratory tract infection by food grade non-decocted granules (Kanglaibao)

Phase 1
Conditions
Accumulated heat in stomach and intestine,respiratory tract infections
Registration Number
ITMCTR2100005403
Lead Sponsor
Beijing University of Chinese Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

(1) It met the diagnostic criteria of accumulated heat in stomach and intestine, and the scale score was > 11;

(2) Aged 3 - 5;

(3) acute respiratory tract infection has been cured for more than 1 week;

(4) Previous winter respiratory tract infections * =3 times;

(5) The legal guardian signs an informed consent and voluntarily participates in this study.

(* Respiratory infections include: common cold, acute sinusitis, otitis media, pharyngitis, tonsil pharyngitis, laryngitis, epiglottitis, acute tracheobronchitis, bronchiolitis and pneumonia)

Note: Patients who meet the above 5 criteria at the same time can be included in this study.

Exclusion Criteria

(1) Recurrent respiratory tract infection caused by organic or congenital respiratory tract lesions was previously diagnosed;

(2) children with primary autoimmune deficiency;

(3) children with serious primary diseases of cardiovascular system, nervous system, genitourinary system, digestive system and hematopoietic system and psychosis;

(4) Children with Down syndrome;

(5) children who received long-term immunomodulator treatment (> 1 week) within 3 months before enrollment;

(6) Children allergic to any component of the study drug.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Changes in degree of accumulated heat in stomach and intestine;
Secondary Outcome Measures
NameTimeMethod
Respiratory tract infection;8-OGdG;
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