AzTrials
AzTrials

LeiomyomaPhase 3NCT02189083

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

A Phase 3 study testing TSD in people with Leiomyoma, run by The University of Hong Kong at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 52 years
Conditions the study is for
Leiomyoma
What is being tested?
TSD
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteChina
Study dates
May 2014to Feb 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 52 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • School of Chinese Medicine, University of Hong Kong

    Hong Kong, 852

Other trials in China

About this study

Official title: A Double-blind, Randomized, Two-dose Trial of Tumor-shrinking Decoction (TSD), a Chinese Medicine Preparation in Patients With Symptomatic Uterine Fibroids

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.

Read more

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).

Read the 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).

Conditions
Leiomyoma
Being tested
TSD
Keywords
Leiomyoma, Medicine, Chinese Traditional, Randomized Controlled Trial
Medical subject headings
Leiomyoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TSDDrug

    Also called Tumor-shrinking Decoction, Chinese medicine preparation

    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.

Study groups in NCT02189083
Study groupRoleWhat they receive
High dose TSDExperimentalSubjects in this arm receive high dose (217 g/day) TSD for 16 weeks.
Receives: Drug: TSD
Low dose TSDActive comparatorSubjects in this arm receive low dose (69 g/day) TSD for 16 weeks.
Receives: Drug: TSD

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and once per month thereafter; Up to 6 months

Secondary outcomes (3)

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

    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.

    Measured: Baseline and once per month thereafter; Up to 6 months

  2. Imaging outcomes

    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.

    Measured: Baseline, 5th month

  3. Serum concentrations of estrogen and follicle-stimulating hormone

    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).

    Measured: Baseline, 5th month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionNov 2015
  4. Study completionFeb 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02189083
Sponsor's protocol ID
HKU-SCM-TSD2014
Other IDs
HMRF-11121841
Status last verified
Jul 2014
First submitted
14 May 2014
Last updated
28 Oct 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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

  • 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.

    PubMed 21812264

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TSD in people with Leiomyoma, run by The University of Hong Kong at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02189083, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in