Efficacy and Safety Study of Sodium Tanshinone IIA Sulfonate on Pulmonary Hypertension
NCT ID: NCT01637675
Last Updated: 2014-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
90 participants
INTERVENTIONAL
2013-05-31
2014-12-31
Brief Summary
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The investigator's objective is to evaluate whether STS exhibits beneficial effects on pulmonary hypertension. This is a randomized, controlled, multicentre clinical trial study. 90 patients with pulmonary hypertension will be enrolled in this study.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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20 mg sildenafil citrate tablets by mouth
20 mg sildenafil citrate tablets by mouth three times a day for 8 weeks
20 mg sildenafil citrate by mouth
20 mg sildenafil citrate tablets by mouth three times a day for 8 weeks
sodium tanshinone IIA sulfonate, sildenafil citrate tablets
sodium Tanshinone IIA sulfonate injection 80 mg diluted with 5% glucose solution(0.9% sodium chloride injection also permitted if necessary) 250ml ivdrip once a day for 8 weeks,20mg sildenafil citrate tablets by mouth three times a day for the same duration
sodium tanshinone IIA sulfonate diluted with 5% glucose solution,20mg sildenafil citrate by mouth
sodium Tanshinone IIA sulfonate injection 80 mg diluted with 5% glucose solution(0.9% sodium chloride injection will also be permitted if necessary) 250ml iv drip once a day for 8 weeks,as well as 20mg sildenafil citrate tablets by mouth three times a day for the same duration of treatment
Interventions
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20 mg sildenafil citrate by mouth
20 mg sildenafil citrate tablets by mouth three times a day for 8 weeks
sodium tanshinone IIA sulfonate diluted with 5% glucose solution,20mg sildenafil citrate by mouth
sodium Tanshinone IIA sulfonate injection 80 mg diluted with 5% glucose solution(0.9% sodium chloride injection will also be permitted if necessary) 250ml iv drip once a day for 8 weeks,as well as 20mg sildenafil citrate tablets by mouth three times a day for the same duration of treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Category 1 or 4 of PH in stable stage according to 2008 Dana Point Conference,including the idiopathic, hereditary, drugs and toxins induced, associated with connective tissue disease or congenital heart disease, and chronic thromboembolic pulmonary arterial hypertension(PAH) ;
3. Male or female between 15 to 70 years old;
4. WHO pulmonary hypertension functional class II or III;
5. The baseline 6-minute walk distance between 150-550 m;
6. Patients' condition should be stable for more than one month after basic treatment; For those patients with congenital heart disease, surgery should have been performed six months or more before they are enrolled in the study;
7. Patients receiving sildenafil treatment only previously, or those without target drugs treatment during the past 3 months;
8. Patients or their guardians should agree with this clinical trail and medical informed consent of the trial should be signed.
Exclusion Criteria
2. Pregnant or lactational women;
3. Important organs with severe diseases;
4. Mental or physical disability;
5. With suspected or indeed alcohol, drug abuse history;
6. With allergic constitution, with two or more drugs or foods allergy history or those who are allergic to any components of the experimental drugs;
7. With both aspartate aminotransferase (AST) and glutamic-pyruvic transaminase (ALT) more than three times of the upper limit of normal in liver function test and Ccr≤50ml/min in kidney function test;
8. Those with systemic blood pressure\<90/50 mmHg, or those uncontrolled dangerous hypertension(BP\>170/110 mmHg);
9. Patients at active stages of infectious or other diseases such as hepatitis A, hepatitis B, AIDS, tuberculosis, and some connective tissue diseases;
10. Patients with severe infection, especially pulmonary infection;
11. Patients with shock or astable hemodynamics with other causes;
12. Patients with hepatic cirrhosis, and hepatic cirrhosis induced portal hypertension;
13. Patients with severe hemorrhage, and hemorrhagic tendency;
14. Patients who need to take or be taking drugs possible or indeed affecting this trial;
15. Patients cannot accomplish required items (especially 6MWD) because of acute/chronic organic disease (excluding dyspnea) or other illnesses such as lower extremity diseases;
16. Patients with any other conditions considered cannot be recruited.
15 Years
70 Years
ALL
No
Sponsors
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Jiangsu Carefree Pharmaceutical Co., Ltd.
INDUSTRY
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
Guangdong Provincial People's Hospital
OTHER
Sir Run Run Shaw Hospital
OTHER
The First Affiliated Hospital of Zhengzhou University
OTHER
Dongguan People's Hospital
OTHER_GOV
Second Affiliated Hospital of Xi'an Jiaotong University
OTHER
Beijing Chao Yang Hospital
OTHER
Beijing Anzhen Hospital
OTHER
The Affiliated Hospital of Qingdao University
OTHER
The First Affiliated Hospital of Guangzhou Medical University
OTHER
Responsible Party
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Nanshan Zhong
Professor
Locations
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The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Jian Wang, MD
Role: primary
References
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He X, Yang F, Wu Y, Lu J, Gao X, Zhu X, Yang J, Liu S, Xiao G, Pan X. Identification of tanshinone I as cap-dependent endonuclease inhibitor with broad-spectrum antiviral effect. J Virol. 2023 Oct 31;97(10):e0079623. doi: 10.1128/jvi.00796-23. Epub 2023 Sep 21.
Other Identifiers
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STS-PH01
Identifier Type: -
Identifier Source: org_study_id