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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)

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)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100005403
Enrollment
Unknown
Registered
2021-12-13
Start date
2021-12-17
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

Accumulated heat in stomach and intestine,respiratory tract infections

Interventions

Non-decocted granule group:Non-decocted granule+Health promotion

Sponsors

Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Changes in degree of accumulated heat in stomach and intestine;

Secondary

MeasureTime frame
Respiratory tract infection;8-OGdG;

Countries

China

Contacts

Public ContactGu Xiaohong
1811505123@163.com18811505123

Outcome results

None listed

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