Study of Tumor-shrinking Decoction (TSD) to Treat Symptomatic Uterine Fibroids
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| ClinicalTrials.gov Identifier: NCT02189083 |
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Recruitment Status :
Completed
First Posted : July 14, 2014
Last Update Posted : October 28, 2020
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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 |
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).
| Study Type : | Interventional (Clinical Trial) |
| Actual 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 |
| Actual Primary Completion Date : | November 2015 |
| Actual Study Completion Date : | February 2016 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: High dose TSD
Subjects in this arm receive high dose (217 g/day) TSD for 16 weeks.
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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 |
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Active Comparator: Low dose TSD
Subjects in this arm receive low dose (69 g/day) TSD for 16 weeks.
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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 |
- Changes in the symptom severity 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.
- Change of clinical response from baseline on the the health-related quality of life 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.
- 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.
- 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).
- 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 |
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
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
| China | |
| School of Chinese Medicine, University of Hong Kong | |
| Hong Kong, China, 852 | |
| Principal Investigator: | Wei Meng | The University of Hong Kong |
Publications of Results:
| Responsible Party: | The University of Hong Kong |
| ClinicalTrials.gov Identifier: | NCT02189083 |
| 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: | October 28, 2020 |
| Last Verified: | July 2014 |
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Leiomyoma Medicine, Chinese Traditional Randomized Controlled Trial |
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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 |