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

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ClinicalTrials.gov Identifier: NCT02189083
Recruitment Status : Unknown
Verified July 2014 by The University of Hong Kong.
Recruitment status was:  Recruiting
First Posted : July 14, 2014
Last Update Posted : July 14, 2014
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong

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).


Condition or disease Intervention/treatment Phase
Leiomyoma Drug: TSD Phase 3

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Two-dose Trial of Tumor-shrinking Decoction (TSD), a Chinese Medicine Preparation in Patients With Symptomatic Uterine Fibroids
Study Start Date : May 2014
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : February 2016

Arm Intervention/treatment
Experimental: High dose TSD
Subjects in this arm receive high dose (217 g/day) TSD for 16 weeks.
Drug: TSD

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 Name: Tumor-shrinking Decoction, Chinese medicine preparation

Active Comparator: Low dose TSD
Subjects in this arm receive low dose (69 g/day) TSD for 16 weeks.
Drug: TSD

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 Name: Tumor-shrinking Decoction, Chinese medicine preparation




Primary Outcome Measures :
  1. Changes in the score of Uterine Fibroid Symptom and Quality of Life questionnaire (UFS-QOL) from Baseline to 6 months [ Time Frame: Baseline and once per month thereafter; Up to 6 months ]
    UFS-QOL consists of 37 items to assess the severity of UFs-related symptoms and the quality of life of patients.


Secondary Outcome Measures :
  1. Change of clinical response from baseline on the the symptom severity of transformed UFS-QOL score [ Time Frame: Baseline and once per month thereafter; Up to 6 months ]
    The secondary clinical outcome is the clinical response that is defined as a ≥30% baseline-to-endpoint reduction on the symptom severity of transformed UFS-QOL score.

  2. Imaging outcomes [ Time Frame: Baseline, 5th month ]
    Imaging outcomes will be examined at baseline and endpoint using magnetic resonance imaging (MRI) scan to determine the number, size and density of the uterine fibroids.

  3. Serum concentrations of estrogen and follicle-stimulating hormone [ Time Frame: Baseline, 5th month ]
    two blood samples will be collected from each patient at baseline and at the end of the study, respectively. The collection of blood will be conducted between 08:00 and 09:00 before meal. Sera will be separated and stored at -20ºC until assayed. Serum concentrations of estrogen, progesterone and follicle-stimulating hormone will be measured using chemiluminescent immunoassay (CLIA).


Other Outcome Measures:
  1. Number of Participants with Serious and Non-Serious Adverse Events [ Time Frame: Up to 6 months ]
    Adverse events will be closely monitored at each visit. All adverse events, reported, elicited or observed, will be recorded on case report form, including the date and time of onset, duration, severity, relationship to study drug, and action taken.



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Ages Eligible for Study:   18 Years to 52 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189083


Contacts
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Contact: Wai Ling Lin 852-54973315 wllin.scm@hku.hk

Locations
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China
School of Chinese Medicine, University of Hong Kong Recruiting
Hong Kong, China, 852
Contact: Wai Ling Lin    852-54973315    wllin.scm@hku.hk   
Principal Investigator: Wei Meng         
Sub-Investigator: Wai Ling Lin         
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Wei Meng The University of Hong Kong

Additional Information:
Publications of Results:
Lu J, Meng W. Clinical observation 45 cases of Yiqi Huayu treatment for uterine fibroids. Gansu TCM. 2008a;6:44-46
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
Meng W, Ma B. Three drugs on cultured uterine leiomyoma cell proliferation and apoptosis, and regulatory factors. Traditional Chinese. 2003;21:2046-2048
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

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Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02189083     History of Changes
Other Study ID Numbers: HKU-SCM-TSD2014
HMRF-11121841 ( Other Grant/Funding Number: Health and Medical Research Fund (HMRF) )
First Posted: July 14, 2014    Key Record Dates
Last Update Posted: July 14, 2014
Last Verified: July 2014
Keywords provided by The University of Hong Kong:
Leiomyoma
Medicine, Chinese Traditional
Randomized Controlled Trial
Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases