Efficacy and Safety Study of Sodium Tanshinone IIA Sulfonate on Pulmonary Hypertension

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

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

Sponsors & Collaborators

• Jiangsu Carefree Pharmaceutical Co., Ltd.

  collaborator INDUSTRY

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  collaborator OTHER

• Guangdong Provincial People's Hospital

  collaborator OTHER

• Sir Run Run Shaw Hospital

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Dongguan People's Hospital

  collaborator OTHER_GOV

• Second Affiliated Hospital of Xi'an Jiaotong University

  collaborator OTHER

• Beijing Chao Yang Hospital

  collaborator OTHER

• Beijing Anzhen Hospital

  collaborator OTHER

• The Affiliated Hospital of Qingdao University

  collaborator OTHER

• The First Affiliated Hospital of Guangzhou Medical University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

15 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-05-31

Primary Completion

2014-12-31

Completion

2014-12-31

Countries

• China

Study Locations