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

NCT02189083 | Completed Phase 3 DMC

• 2 other identifiers: HKU-SCM-TSD2014HMRF-11121841
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Leiomyoma

Keywords

Leiomyoma; Medicine, Chinese Traditional; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Changes in the symptom severity score of Uterine Fibroid Symptom and Quality of Life questionnaire (UFS-QOL) from Baseline to 6 months

  UFS-QOL consists of 37 items to assess the severity of UFs-related symptoms and the quality of life of patients.

  Baseline and once per month thereafter; Up to 6 months

Secondary Outcomes (3)

• Change of clinical response from baseline on the the health-related quality of life of transformed UFS-QOL score

  Baseline and once per month thereafter; Up to 6 months

• Imaging outcomes

  Baseline, 5th month

• Serum concentrations of estrogen and follicle-stimulating hormone

  Baseline, 5th month

Other Outcomes (1)

• Number of Participants with Serious and Non-Serious Adverse Events

  Up to 6 months

Study Arms (2)

High dose TSD

EXPERIMENTAL

Subjects in this arm receive high dose (217 g/day) TSD for 16 weeks.

Drug: TSD

Low dose TSD

ACTIVE COMPARATOR

Subjects in this arm receive low dose (69 g/day) TSD for 16 weeks.

Drug: TSD

Interventions

TSD DRUG

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.

Also known as: Tumor-shrinking Decoction, Chinese medicine preparation

High dose TSD; Low dose TSD

Eligibility Criteria

• Age: 18 Years - 52 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Premenopausal women aged 18 to 52 years; and
• have a primary diagnosis of symptomatic UFs based on clinical symptoms; and
• MRI examination as defined in the International Classification of Diseases (10th edition).

You may not qualify if:

• Unstable medical conditions such as serious cardiovascular diseases;
• With severe neuropsychiatric disorders;
• Combined with adenomyosis or other tumors;
• On treatment with Chinese medicine or other natural products in the previous 3 months;
• With an allergic history of herbal medicine; or
• Being pregnant and lactating women and those who currently use contraception.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

School of Chinese Medicine, University of Hong Kong

Hong Kong, 852, China

Location

Related Publications (5)

• Lu J, Meng W. Clinical observation 45 cases of Yiqi Huayu treatment for uterine fibroids. Gansu TCM. 2008a;6:44-46

  RESULT

• Lu J, Meng W. Clinical Observation of " Hualiu Recipe" in Treating 302 Cases of Hysteromyoma with Qi- Deficiency and Blood- Stasis Syndrome. Shanghai Traditional Chinese Medicine. 2008b;3:49-51

  RESULT

• Meng W, Ma B. Three drugs on cultured uterine leiomyoma cell proliferation and apoptosis, and regulatory factors. Traditional Chinese. 2003;21:2046-2048

  RESULT

• Meng W. Zhao W. Effects of methods of invigorating qi and dissolving stasis on the expression of proliferating and apoptosis of cultured human uterine leiomyoma cells. Chinese archives of traditional Chinese medicine. 2008(2);238-240

  RESULT

• Tan L, Meng W, Zhang TT. [Predisposing factors of hysteromyoma and effect of hualiu recipe on it]. Zhongguo Zhong Xi Yi Jie He Za Zhi. 2011 May;31(5):635-8. Chinese.

  PMID: 21812264 RESULT

Related Links

• American Society of Reproductive Medicine Patient Booklet: Uterine Fibroids

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Wei Meng

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2014
• First Posted: July 14, 2014
• Study Start: May 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: February 1, 2016
• Last Updated: October 28, 2020

Record last verified: 2014-07

Locations

CN (1)