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Clinical Research on the Effect of Yiqigubiao Pills on Stable Chronic Obstructive Pulmonary Diseases (stable COPD)

Clinical Research on the Effect of Yiqigubiao Pills on Stable Chronic Obstructive Pulmonary Diseases (stable COPD)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12001928
Enrollment
Unknown
Registered
2012-01-09
Start date
2012-01-30
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

Chronic Obstructive Pulmonary Disease

Interventions

Normol A:Basic treatment: Salbutamol aerosol when need, 100-200ug a time, aerosol inhalation
if not satisfied with the effects, plus the aminophylline sustained-release tablets 0.1g, Bid, PO
other drugs for COPD are forbidden.
Test A:The same therateupics with the control for A Test Group plus Yiqigubiao Pills
Normol B:If the drugs like Seretide or Spiriva etc, are used before the trail, any change about the drugs, the dosage and the formulations is forbidden
if no drugs used before the trail and the diseas are controllable, no drugs will be subjoined
if no drugs used before the trail, but the diseas out of controlling, the Seretide 50/250ug Bid or Spiriva QD will be given, plus aminophylline 0.1g, PO, according to the disease. and the case will be
Test B:The same therateupics with the control for B Test Group plus Yiqigubiao Pills
Normol C:If the drugs like Seretide or Spiriva etc, are used before the trail, any change about the drugs, the dosage and the formulations is forbidden
if no drugs used before the trail, but the diseas out of controlling, the Seretide 50/250ug Bid or Spiriva QD will be given, plus aminophylline 0.1g, PO, according to the disease and the case will be
Test C:The same therateupics with the control for C Test Group plus Yiqigubiao Pills
Normol D:Basic treatment:Seretide 50/250ug,inhalation,Bid
if out of controlling,plus the Spiriva 18ug,inhalation,QD
or the aminophylline will be added,0.1g,PO,Bid.nd the case will be accepted after 4-6wks when the disease turn to be stable pahse,also any change about the drugs,the dosage and the formulations is for
the Salbutamol aerosol will be given when need,100-200ug,aerosol inhalation.other drugs for COPD are forbidden.
Test D:The same therateupics with the control for D Test Group

Sponsors

The Affiliated Hospital of Traditional Chinese Medicine of Xinjiang Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Volunteers; 2. Age from 40-80 years; 3. Patients corresponding to diagnosis standards of stable COPD (types of A, B, C, D) ; 4. Patients corresponding to diagnosis standards of Lung Distension (syndrome of Deficiency of Lung-Spleen Qi and Obstruction of the Lung by Phlegm).

Exclusion criteria

Exclusion criteria: 1. Patients with pneumothorax, pleural effusion, lung cancer, active tuberculosis and other serious lung disease; 2. Patients with serious cardiovascular, primary disease of liver, kidney, hematopoietic system; 3. Acute exacerbation of chronic obstructive pulmonary disease; 4. When screening inspection the ALT/AST value was 1.5 times of the upper normal limit; 5. Patients with psychosis; 6. Women in stage of pregnant or lactation; 7. People with allergies or multiple drug allergy; 8. Patients with tumors; 9. People with congenital or acquired immunodeficiency; 10. Patients participate in other clinical trials in the recent month;

Design outcomes

Primary

MeasureTime frame
6-minute walking distance;ModifiedMedical Research Council Scale,MMRC;COPD assessment test, CAT;the times and severity of exacerbation;rate of hospitalization;TCM symptom mark;

Secondary

MeasureTime frame
Pulmonary Function;IL-6,8;TNF-alpha;CD4, CD;

Countries

China

Contacts

Public ContactLi Feng-sen
fengsen602@163.com+86 13999980996

Outcome results

None listed

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