Trials / Unknown
UnknownNCT01637675
Efficacy and Safety Study of Sodium Tanshinone IIA Sulfonate on Pulmonary Hypertension
Clinical Study of Effects of Sodium Tanshinone IIA Sulfonate on Pulmonary Hypertension
- Status
- Unknown
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- Sponsor
- The First Affiliated Hospital of Guangzhou Medical University · Academic / Other
- Sex
- All
- Age
- 15 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
Sodium tanshinone IIA sulfonate (STS) is a water-soluble derivative of tanshinone IIA isolated as the main pharmacologically active natural compound from a traditional Chinese herbal medicine,the dried root of Salvia miltiorrhiza Bunge known as Danshen. Danshen has been known for the function of improving body functions such as activating blood circulation and removing blood stasis according to the theory of traditional Chinese medicine. Danshen and its various formula products including STS have been long-time widely used in oriental countries, especially China to treat various inflammatory and cardiovascular diseases for its pharmacological actions, including vasodilatation, anticoagulation, anti-inflammation, and free radical scavenging,with negligible adverse effects observed. 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.
Conditions
- Pulmonary Hypertension
- Pulmonary Arterial Hypertension
- Cardiovascular Diseases
- Lung Diseases
- Tanshinone IIA Sulfonate
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 20 mg sildenafil citrate by mouth | 20 mg sildenafil citrate tablets by mouth three times a day for 8 weeks |
| DRUG | 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 |
Timeline
- Start date
- 2013-05-01
- Primary completion
- 2014-12-01
- Completion
- 2014-12-01
- First posted
- 2012-07-11
- Last updated
- 2014-03-31
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT01637675. Inclusion in this directory is not an endorsement.