Study of Tumor-shrinking Decoction (TSD) to Treat Symptomatic Uterine Fibroids

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

Summary

On the basis of empirical evidence and clinical practice, the investigators have developed a formula called Tumor-shrinking Decoction (TSD) used in the treatment of uterine fibroids (UFs). The investigators preliminary clinical observation has demonstrated the benefits of TSD in improving UFs.

TSD is composed of 15 individual Chinese medicines: Astragalus Membranaceus, Semen Coicis, Poria, Curcuma longa L, and Fritillaria Thunbergii Miq, Cassia twig, Pollen typhae, Resina draconis, Lithospermum erythrorhizon, Halloysitum Rubrum, Rhizoma Corydalis processed with vinegar, Hirudo, Calcined corrugated sub , Oyster Shell and Laminaria Japonica Aresch.

It is hypothesized that TSD can effectively reduce the fibroid size and improve the symptoms associated with UFs and the greater anti-tumor potency of TSD is associated with higher therapeutic doses.

To test this hypothesis, one 16-week, double-blind, randomized, two-dose trial will be conducted in patients with symptomatic UFs to determine whether the high dose (217 g/day) of TSD could produce significantly greater effects in reducing the fibroid size and improving its related symptoms and biochemical profiles compared to the lower dose (69 g/day).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Hong Kong

Criteria

Inclusion Criteria:

1. Premenopausal women aged 18 to 52 years; and

2. have a primary diagnosis of symptomatic UFs based on clinical symptoms; and

3. MRI examination as defined in the International Classification of Diseases (10th edition).

Exclusion Criteria:

1. Unstable medical conditions such as serious cardiovascular diseases;

2. With severe neuropsychiatric disorders;

3. Combined with adenomyosis or other tumors;

4. On treatment with Chinese medicine or other natural products in the previous 3 months;

5. With an allergic history of herbal medicine; or

6. Being pregnant and lactating women and those who currently use contraception.