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Efficacy and safety of Tanshinone II A sulfonic acid sodium aerosol inhalation

Efficacy and safety of Tanshinone II A sulfonic acid sodium aerosol inhalation

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-15006669
Enrollment
Unknown
Registered
2015-06-30
Start date
2015-08-01
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

pulmonary artery hypertension

Interventions

control :basic treatment
experimental group:tanshinone IIA sulfonic acid natrium aerosol inhalation based on routine treatment

Sponsors

The First Affiliated Hospital of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 75 Years

Inclusion criteria

Inclusion criteria: Diagnostic criteria: (1) conform to the pulmonary artery high pressure at sea level, the resting state, the right cardiac catheterization examination average pulmonary artery pressure (mPAP) 25 mm Hg or higher, and pulmonary capillary wedge pressure (PCWP) 15 MMHG or less; (2) the nice classification in 2013 patients with 1, 3, 4 class period, specific include: idiopathic pulmonary hypertension. Hereditary pulmonary hypertension; A drug or poison causes of pulmonary hypertension; Related factors caused by pulmonary hypertension [connective tissue disease, congenital heart disease (no indications/intervention or surgery/more than 6 months after intervention treatment and stable)]; Chronic obstructive pulmonary disease, interstitial lung disease, and other restrictive and obstructive airway disorders combination disease, long-term living plateau environment caused by pulmonary hypertension; Chronic thromboembolic pulmonary hypertension [with surgical indications is the preferred surgical treatment, postoperative pulmonary hypertension is still exist, or no surgical indications should be use of anticoagulant drugs (such as warfarin) stability more than 1 months]; (3) age 15 to 70 years old, men and women not limited; (4) WHO pulmonary artery II, III, IV level; (5) 6 MWDS baseline acuity 100 m and 450 m; (6) the subjects after foundation treatment in stable condition after more than 1 months, patients with congenital heart disease intervention or surgery sealing treatment for 6 months or more; (7) the participants or their guardians agree to participate in this test, and sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) does not have legal capacity and legal capacity limitation; (2) during pregnancy and lactation women; (3) important organs have serious primary diseases, responsible for doctors determined doesn't fit into the group; (4) on the mental or physical disability patients, responsible for doctors determined doesn't fit into the group; (5) doubt or have alcohol and drug abuse history; (6) this medicine composition has known allergies; (7) AST, ALT 3 times more than normal ceiling, Ccr 50 ml/min or less; (8) systemic blood pressure in patients with low blood pressure ( blood pressure 170/110 MMHG); (9) for ever use targeted drug therapy and disable or change the targeted drugs less than 3 months; (10) including hepatitis a and hepatitis b, HIV/AIDS, tuberculosis and other infectious diseases, or connective tissue diseases in activity; (11) severe infections, especially lung infection; (12) shock or other hemodynamic instability; (13) cirrhosis of the liver or liver cirrhosis patients with portal hypertension causedPatients with portal hypertension; (14) for severe bleeding or bleeding tendency, such as active peptic ulcer, intracranial hemorrhage, trauma, or other bleeding; (15) and organic acute or chronic disease (except breathing difficulties) or for other reasons such as lower limbs diseases lead to cannot fulfill the study subjects need to monitor that required by the project (especially 6 min walking distance testing); (16) researchers think doesn't fit to participate in the test of any other person.

Design outcomes

Primary

MeasureTime frame
six-minutes walking test;A second heart rate recovery;

Secondary

MeasureTime frame
pulmonary artery systolic pressure by Echocardiography;Liver Function;renal function;

Countries

China

Contacts

Public ContactJian Wang
jianwang1986@yahoo.com+86 15013388183

Outcome results

None listed

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