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The efficacy and safety evaluation of Tongchuanqing Granule in children's chronic persistent period of Bronchial Asthma with dyspnea due to deficiency syndrome: a multi-center,Randomized,doubled-blind, placebo-controlled trial

The efficacy and safety evaluation of Tongchuanqing Granule in children's chronic persistent period of Bronchial Asthma with dyspnea due to deficiency syndrome: a multi-center,Randomized,doubled-blind, placebo-controlled trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13003324
Enrollment
Unknown
Registered
2013-06-14
Start date
2013-07-15
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Asthma

Interventions

A:Tongchuanqing Granules(5 to 7 years: Take 1 bag (3G), 2 times a day. 8 to 10 years: take 1.5 bag (4.5g), 2 times a day. 11 to 14 years: take 2 bag (6g), 2 times a day)
B:placebo (5 to 7 years: Take 1 bag (3G), 2 times a day. 8 to 10 years: take 1.5 bag (4.5g), 2 times a day. 11 to 14 years: take 2 bag (6g), 2 times a day)

Sponsors

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 14 Years

Inclusion criteria

Inclusion criteria: All must meet the following six criteria: 1. diagnosed with childrens Bronchial Asthma, chronic persistent period,Severity classification is 2nd or 3rd(mild persistent or moderate persistent); 2. Meeting deficiency asthma TCM syndrome; 3. Aged between 5 to 14 year-old; 4. Initial diagnosis or did not receive GINA standard treatment; 5. without use beta 2 agonists, glucocorticoids, oral beta 2 agonists, or leukotriene receptor antagonists in 2 weeks; not use systemic corticosteroids and immunomodulators in 4 weeks; 6. Fully informed, voluntary consent, and signed the ICF by legal guardians.

Exclusion criteria

Exclusion criteria: With one of the following items should not be included in this study 1. The patients have the other diseases that also cause breathlessness or dyspnea; 2. Complicated with serious life-threatening diseases, such as heart and brain blood vessels, liver, kidney and hematopoietic system disease ,or Wasting diseases,such as malignancies,tuberculosis and so on; 3. Can not use the test Syndrome condition explanation serum creatinine (Cr), blood urea nitrogen (BUN) and glutamic-pyruvic transaminase (ALT) increased; 4. Allergic to the drug used in this study; 5. Children can not cooperate or are participating in clinical trials of other drugs; 6. Children are too young to use peak flow meter; 7. According to the doctor's judgment, other diseases may reduce the including possibility or complicate including.

Design outcomes

Primary

MeasureTime frame
PEF measured values(every morningt) and PEF mutation rate per week;

Secondary

MeasureTime frame
Forced expiratory volume in one second %predicted;The frequency and values of Daytime symptoms & Nocturnal Symptoms;Short-acting ?2 –agonist use;

Countries

China

Contacts

Public ContactSiyuan Hu
husiyuan1963@sina.com+86 022 27432275

Outcome results

None listed

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