Study of Tumor-shrinking Decoction (TSD) to Treat Symptomatic Uterine Fibroids
Condition: Leiomyoma
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional
Phase: Phase 3

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).
    

Detailed description: 
      Numerous Chinese medicine preparations have been shown to possess therapeutic potential in
      relieving uterine fibroids (UFs) symptoms and shrinking the volume of fibroids without
      significant adverse effects, although the clinical efficacy needs to be further confirmed
      with rigorously designed.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 UFs. The investigators preliminary clinical observation has demonstrated the
      benefits of TSD in improving UFs.

      TSD is composed of 15 individual Chinese medicines. According to traditional Chinese medicine
      (TCM) doctrine, most UFs are developed due to the deficiency of vital energy and the stasis
      of blood, resulting in the formation of pathological massive tissues. Individual Chinese
      medicines constituting TSD can be classified into three classes based on TCM-defined
      pharmacological actions: (i) Tonifying qi and resolve phlegm: Astragalus Membranaceus, Semen
      Coicis, Poria, Curcuma longa L, and Fritillaria Thunbergii Miq; (ii) Resolve stasis, stopping
      bleeding and relieve pain: Cassia twig, Pollen typhae, Resina draconis, Lithospermum
      erythrorhizon, Halloysitum Rubrum, Rhizoma Corydalis processed with vinegar; and (iii)
      Softening hardness and dissipate binds: Hirudo, Calcined corrugated sub , Oyster Shell and
      Laminaria Japonica Aresch.

      Indeed, the investigators previous studies of cultured cells and animals have revealed that
      TSD robustly inhibits fibroid cell growth and proliferation. The investigators therefore
      hypothesize 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).
    

Intervention name(s): TSD
Intervention type(s): Drug
Intervention description(s): 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.
High dose (127g) or Low dose (69g) TSD decoction boiled as 200ml per bag; 2 bags per day, 6 days per week; Orally in-take one bag of TSD decoction in morning and another in evening after meal; The whole treatment lasts for 16 weeks.
Other intervention name(s): Tumor-shrinking Decoction, Chinese medicine preparation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Leiomyoma; Medicine, Chinese Traditional; Randomized Controlled Trial