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Effect and safety of Shenmai injection in the treatment of Chronic obstructive pulmonary disease complicated with chronic pulmonary heart disease (both Qi and Yin deficiency): a multicenter, randomized, blinding, controlled trial

Effect and safety of Shenmai injection in the treatment of Chronic obstructive pulmonary disease complicated with chronic pulmonary heart disease (both Qi and Yin deficiency): a multicenter, randomized, blinding, controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12002889
Enrollment
Unknown
Registered
2012-12-19
Start date
2012-09-05
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 complicated with chronic pulmonary heart disease (both Qi and Yin deficiency)

Interventions

Experimental:Shenmai injection 60ml with 5% glucose injection 250ml intravenous infusion a day for 10 days
control:5% glucose injection 60ml with 5% glucose injection 250ml intravenous infusion a day for 10 days

Sponsors

Chengdu University of TCM Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. To be diagnozed as Chronic obstructive pulmonary disease complicated with chronic pulmonary heart disease (Qi and Yin deficiency); 2. Aged 35~70 years; 3. Heart function I~III grade; 4. Signed the informed consent according to the GCP principle.

Exclusion criteria

Exclusion criteria: 1. Tem. >=38.0 degree C; 2. Heart function deficiency caused by other reason; 3. Complicated with diabetes mellitus, hypertension (high risk, high risk), severe arrhythmia; 4. Onset myocardial infarction or acute coronary syndrome in past three months; 5. Patient with respiratory insufficiency needs invasive mechanical ventilation; 6. Patient complicated with cardiac neurosis, psychosis, depression; 7. Patient complicated with other severe organic liver, or kidney, or blood system

Design outcomes

Primary

MeasureTime frame
Change of the symptoms include short breath, palpitations, dry mouth;Change of the both Qi Yin deficiency zheng;COPD CAT score;

Secondary

MeasureTime frame
Change of FEVlFEVl, FEVl/FVCFEVl/FVC;The whole blood viscosity (high, low shear), plasma viscosity, erythrocyte rheological properties, plasma;eart function by NYHA grade;Pulmonary artery pressure (by echocardiography);

Countries

China

Contacts

Public ContactDuan Junguo
duangjg@vip.sina.com+86 13808048959

Outcome results

None listed

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