Study of Tumor-shrinking Decoction (TSD) to Treat Symptomatic Uterine Fibroids
Status:
Completed
Trial end date:
2016-02-01
Target enrollment:
Participant gender:
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).