Hyperplasia of Mammary GlandsPhase 3NCT06685978
Efficacy and Safety of Xiangjurupining Capsule for Hyperplasia of Mammary Glands
A Phase 3 study testing Xiang Ju Ru Pi Ning capsule in people with Hyperplasia of Mammary Glands, run by Tasly Pharmaceutical Group Co., Ltd at 27 sites in China.
Trial summary
This study will evaluate the efficacy and Safety of Xiangjurupining Capsule in the treatment of Hyperplasia of Mammary Glands(stagnation of liver-qi and phlegm). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hyperplasia of Mammary Glands
- What is being tested?
- Xiang Ju Ru Pi Ning capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 430 participants
- Where
- 27 sitesChina
- Study dates
- 26 Apr 2024to 31 Jul 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female patients aged 18 to 50 (including boundary values);
- Those who meet the diagnostic criteria for breast hyperplasia in Western medicine and have a disease course of more than 3 months;
- Meets the traditional Chinese medicine differentiation criteria for liver depression and phlegm coagulation syndrome;
- The BI-RADS grading of the target side breast ultrasound is 2-3 levels, while the BI-RADS grading of the non target side breast ultrasound is 1-3 levels;
- During the screening period, the NRS score is ≥ 4 and there is a target mass detected by palpation;
- During the introduction period, the average NRS score within the day of pain involvement is ≥ 4 points, and there is still the presence of the target mass on palpation;
- During the import period, the number of days with pain involvement in the menstrual cycle is greater than 7 days;
- With informed consent, voluntarily participate in the experiment and sign the informed consent form.
Who cannot join
- Those who suffer from other breast diseases or breast pain caused by other reasons, such as mastitis, breast cancer, etc;
- Patients with severe cardiovascular, cerebrovascular, liver, kidney, malignant tumors, hematological diseases, and psychiatric disorders;
- Patients who have been previously diagnosed with dysfunctional uterine bleeding, amenorrhea, polycystic ovary syndrome, menopausal syndrome, hyperprolactinemia, Cushing's syndrome, and other diseases and still require treatment by adjusting hormone levels; Individuals who have been diagnosed with diseases that require long-term use of painkillers, such as dysmenorrhea, and are expected to be unable to stop using painkillers during the trial period.
- Abnormal liver function (ALT or AST or ALP or GGT>1.2 times the upper limit of normal values) or abnormal kidney function (serum Cr or BUN or Urea>1.2 times the upper limit of normal values) that the researcher considers clinically significant and is not suitable for participation in clinical trials;
- Women who are in pregnancy, lactation, menopause, or have a pregnancy plan within the past 6 months;
- Chinese and western medicines and other therapies (including external application medicine, acupuncture and moxibustion, etc.) used to treat breast hyperplasia or relieve breast pain within 1 month or 5 half lives (whichever is the shortest) before screening and during the induction period, or contraceptives and sex hormone drugs have been used within half a year;
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- Individuals with severe menstrual cycle and/or menstrual irregularities (menstrual cycle>35 days or<21 days and/or menstrual period<3 days or>7 days);
- Individuals with allergic constitution and known allergies to the components of the experimental drug prescription;
- Suspect or have a history of alcohol and drug abuse;
- Select patients who have participated in clinical trials and used investigational drugs within the previous month;
- Failure to follow the physical contraceptive measures recognized by researchers for contraception;
- According to the researchers' assessment, there may be other conditions or conditions that reduce the likelihood of inclusion or complicate the trial, such as frequent changes in the work environment that can lead to loss to follow-up, and individuals who cannot provide sufficient informed consent due to mental and behavioral disorders.
Trial locations and contacts
27 sites in 1 country. Contact the study team or a site near you to ask about taking part.
27 sites in 1 country
China27 sites, 27 recruiting
- Recruiting
Guang 'anmen Hospital Baoding Hospital
Baoding, Hebei
Linjing Qiao, 15176205175, qiaolj2018@126.com
- Recruiting
Dongzhimen Hospital, Beijing University of Chinese Medicine
Beijing, Beijing Municipality
Xiaoguang Shi, 13301119560, 13301119560@163.com
- Recruiting
East Hospital of Beijing University of Chinese Medicine
Beijing, Beijing Municipality
Lina Zhao, 13391956256, 13391956256@163.com
- Recruiting
Guang 'anmen Hospital
Beijing, Beijing Municipality
Juefei Mo
- Recruiting
Cangzhou Hospital of Integrated Chinese and Western Medicine
Cangzhou, Hebei
Ruizhen Luo, 18031783799, luoruizhen2008@126.com
- Recruiting
The First Affiliated Hospital of Hunan University of Chinese Medicine
Changsha, Hunan
Jinhui Hu, 13637412178, Hujinhui173@163.com
- Recruiting
Chongqing Traditional Chinese Medicine Hospital
Chongqing, Chongqing Municipality
Gang Lu, 18696708566, lgcmu@126.com
- Recruiting
Oilfields General Hospital in Daqing
Daqing, Heilongjiang
Xiang Yin, 13936767996, yinxiang_dq@163.com
- Recruiting
Guangdong Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong
Rui Xu, 18903068226, Catdoctor007@163.com
- Recruiting
Zhejiang Provincal Hospital of TCM
Hangzhou, Zhejiangsheng
Xiaohong Xie, 13957101427, xxh666857@163.com
- Recruiting
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Jinan, Shandong
Xiaofei Liu, 15615611377, drliuxf@126.com
- Recruiting
Luoyang Third People's Hospital
Luoyang, Henan
Jingyu Miao, 13353907277, jingyu_miao2228@sina.com
- Recruiting
Jiangsu Provincial Hospital of Traditional Chinese Medicine
Nanjing, Jiangsu
Chang Yao, 18915999830, yaochang67@126.com
- Recruiting
Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality
Yuenong qin, 18917763372, Frank_yching@aliyun.com
- Recruiting
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality
Xueqing Wu, 13817792022, snow_zi@hotmail.com
- Recruiting
Hebei Provincial Hospital of Traditional Chinese Medicine
Shijiazhuang, Hebei
Wenhui Bian, 13073177138, Bwh1966@sina.com
- Recruiting
The Second Affiliated Hospital of Shandong First Medical University
Taian, Shandong
Xianqi Li, 18505386835, drlixqi@126.com
- Recruiting
Shanxi Hospital of Traditional Chinese Medicine
Taiyuan, Shanxi
Yue Shi, 13835106093, smy4669066@163.com
- Recruiting
The First Affiliated Hospital of Tianjin University of Chinese Medicine
Tianjin, Tianjin Municipality
Jiandong Jia, 13752366661, jiajiandong8835@sina.com
- Recruiting
Urumqi maternal and child Health Care Hospital
Ürümqi, Xinjiang
Dongmei Rao, 13639950825, 1501992393@qq.com
- Recruiting
Weifang Hospital of Traditional Chinese Medicine
Weifang, Shandong
Guolou li, 18606361899, cylgl123@163.com
- Recruiting
Wuhan Third Hospital
Wuhan, Hubei
Zhengyan Zhu, 13618601816, 3196924@qq.com
- Recruiting
Xiamen Hospital of Traditional Chinese Medicine
Xiamen, Fujian
Junpeng Chen, 13599910916, cjp7978@sohu.com
- Recruiting
Xuzhou Central Hospital
Xuzhou, Jiangsu
Cuntao Lu, 18952171927, lct71927@163.com
- Recruiting
North Jiangsu People's Hospital
Yangzhou, Jiangsu
DeYuan Fu, 18051060677, fdy1003@163.com
- Recruiting
Zhengzhou People's Hospital
Zhengzhou, Henan
Bing Niu, 15837186280, niu49@sina.com
- Recruiting
The First Affiliated Hospital of Hunan College of Traditional Chinese Medicine (Hunan Provincial Direct Hospital of Traditional Chinese Medicine)
Zhuzhou, Hunan
Lingli Zhang, 13007338538, 1053914246@qq.com
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center Phase III Clinical Trial of Efficacy and Safety of Xiangjurupining Capsule in the Treatment of Hyperplasia of Mammary Glands(Syndrome of Stagnation of Liver-qi and Phlegm)
This study will evaluate the efficacy and Safety of Xiangjurupining Capsule in the treatment of Hyperplasia of Mammary Glands(stagnation of liver-qi and phlegm).
Read the detailed description
Xiangjurupiling Capsule is an oral pure Chinese medicine preparation.This study will evaluate the efficacy and Safety of Xiangjurupining Capsule in the treatment of Hyperplasia of Mammary Glands(stagnation of liver-qi and phlegm).
- Conditions
- Hyperplasia of Mammary Glands
- Being tested
- Xiang Ju Ru Pi Ning capsule Placebo, Xiang Ju Ru Pi Ning capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xiang Ju Ru Pi Ning capsule PlaceboDrug
Also called Placebo group
Xiang Ju Ru Pi Ning capsule Placebo(0.45g per capsule ) 4 capsules each time,p.o.,tid,for 3menstrual cycle.
Xiang Ju Ru Pi Ning capsuleDrug
Also called Experimental group
Xiang Ju Ru Pi Ning capsule (0.45g per capsule ) 4 capsules each time,p.o.,tid,for 3menstrual cycle.
| Study group | Role | What they receive |
|---|---|---|
| :Xiangjurupining Capsule Placebo group | Placebo comparator | Xiang Ju Ru Pi Ning capsule Placebo(0.45g per capsule ) 4 capsules each time,p.o.,tid,for 3menstrual cycle. Receives: Drug: Xiang Ju Ru Pi Ning capsule Placebo |
| Xiangjurupining Capsule Experimental group | Experimental | Xiang Ju Ru Pi Ning capsule (0.45g per capsule ) 4 capsules each time,p.o.,tid,for 3menstrual cycle. Receives: Drug: Xiang Ju Ru Pi Ning capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief rate
Breast pain (NRS score) remission rate from baseline.Subject reported breast pain usingNRs( NumericalRatine Scalelscale onthe subiect daily diary.The NRS scale is a line composed of several points, marked with a scale of 0 to 10.The subjects rated themselves according to the most painful degree every day. The higher the score, the higher the degree of pain.
Measured: Baseline to the 3rd menstrual cycle
Secondary outcomes (10)
Pain disappearance rate
Breast pain (NRS score) disappearance rate from baseline.Subject reported breast pain usingNRs( NumericalRatine Scalelscale onthe subiect daily diary.The NRS scale is a line composed of several points, marked with a scale of 0 to 10.The subjects rated themselves according to the most painful degree every day. The higher the score, the higher the degree of pain.
Measured: Baseline to the 3rd menstrual cycle
Changes in mean NRS scores from baseline within days of pain involvement
The mean value of breast pain per menstrual cycle was calculated from baseline.Subject reported breast pain usingNRs( NumericalRatine Scalelscale onthe subiect daily diary.The NRS scale is a line composed of several points, marked with a scale of 0 to 10.The subjects rated themselves according to the most painful degree every day. The higher the score, the higher the degree of pain.
Measured: Baseline to the 3rd menstrual cycle
Changes in maximum NRS scores from baseline
Capture the highest value of breast pain per menstrual cycle from baseline.Subject reported breast pain usingNRs( NumericalRatine Scalelscale onthe subiect daily diary.The NRS scale is a line composed of several points, marked with a scale of 0 to 10.The subjects rated themselves according to the most painful degree every day. The higher the score, the higher the degree of pain.
Measured: Baseline to the 3rd menstrual cycle
Change in pain AUC (area under pain-time curve) from baseline
The pain AUC was calculated from baseline based on the breast pain NRS score per menstrual cycle.
Measured: Baseline to the 3rd menstrual cycle
Change from baseline in days with NRS≥4 points
The number of days in each menstrual cycle with an NRS score greater than 4 for breast pain was captured from baseline.Subject reported breast pain usingNRs( NumericalRatine Scalelscale onthe subiect daily diary.The NRS scale is a line composed of several points, marked with a scale of 0 to 10.The subjects rated themselves according to the most painful degree every day. The higher the score, the higher the degree of pain.
Measured: Baseline to the 3rd menstrual cycle
Within a few days of pain involvement within a menstrual cycle, the average NRS score decreased by 70% from baseline.
The mean NRS score decrease from baseline within days of pain involvement was 70%.Subject reported breast pain usingNRs( NumericalRatine Scalelscale onthe subiect daily diary.The NRS scale is a line composed of several points, marked with a scale of 0 to 10.The subjects rated themselves according to the most painful degree every day. The higher the score, the higher the degree of pain.
Measured: Baseline to the 3rd menstrual cycle
TCM syndrome scores
Compared wth baseline;the scores of changes ofTCM syndrome Evaluaion at each visit .This instrument consists oftwo primary symptoms:breast pain,breast mas ,and foursecondary symptoms.fourlevels to measure severtyof primarysymptoms (0.2、4、6) and secondarysymptoms (0、1、2.3),respectively. Record the tongue and pulseconditions. The TCM syndrome efect calculated bynimodipine method. The final score has a rangeof0 to 100. The efect ofTCM syndrome from 0% negative) to 100%(disappear).
Measured: the 3rd menstrual cycle after treatment
SF-36V2
Changes in SF-36 V2 scale scores and total scores from baseline.The SF-36 scale is a universal scale developed by the American medical research group to assess the quality of life (17 Appendix: SF-36 v2 rating scale), which is widely recognized and used in the world. The SF-36 v2 scale includes 36 entries that assess health-related quality of life in eight dimensions: physiological function (PF), physiological function (RP), physical pain (BP), general health (GH), vitality (VT), social function (SF), emotional function (RE), and mental health (MH). A Health Change (HT) entry is also included. The quality of life was retrospectively evaluated by the participants at visit 2, visit 5 and visit 6. The higher the score, the higher the quality of life. The results of V2 examination were used as the baseline to calculate the scores of all dimensions of quality of life and the total score.
Measured: the 3rd menstrual cycle after treatment
The target lump
Assess the scope the size and the hardness of the tareet lump by palpation.The doctor palpated the breast ofthe subjects and measured the size of the target lump with a ruler .Four quadrant method was used to record the number of the target lump's quadrants. Four level(0.2.4.6)to measure The scope,the size and the hardness of lump .The score from 0(none) to 6(most severe).
Measured: the 3rd menstrual cycle after treatment
The target lump area
Assess the breast glandular section thickness and nodules of the target lump area by B-ultrasound.
Measured: the 3rd menstrual cycle after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start26 Apr 2024
- Primary completion30 Apr 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperplasia of Mammary GlandsStudies of the same condition, open and under way.
- More trials run by Tasly Pharmaceutical Group Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tasly Pharmaceutical Group Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06685978
- Sponsor's protocol ID
- TSL-TCM-XJRPNJN-III
- Status last verified
- Nov 2024
- First submitted
- 7 Nov 2024
- Last updated
- 13 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multi-center Phase III Clinical Trial of Efficacy and Safety of Xiangjurupining Capsule in the Treatment of Hyperplasia of Mammary Glands(Syndrome of Stagnation of Liver-qi and Phlegm)
- ClinicalTrials.gov ID
- NCT06685978
- Acronym / sponsor ID
- TSL-TCM-XJRPNJN-III
- Conditions
- Hyperplasia of Mammary Glands
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- Tasly Pharmaceutical Group Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2024 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 13 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy and Safety of Xiangjurupining Capsule in the treatment of Hyperplasia of Mammary Glands(stagnation of liver-qi and phlegm).
Detailed description
Xiangjurupiling Capsule is an oral pure Chinese medicine preparation.This study will evaluate the efficacy and Safety of Xiangjurupining Capsule in the treatment of Hyperplasia of Mammary Glands(stagnation of liver-qi and phlegm).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| :Xiangjurupining Capsule Placebo group | Placebo comparator | Drug: Xiang Ju Ru Pi Ning capsule PlaceboXiang Ju Ru Pi Ning capsule Placebo(0.45g per capsule ) 4 capsules each time,p.o.,tid,for 3menstrual cycle. |
| Xiangjurupining Capsule Experimental group | Experimental | Drug: Xiang Ju Ru Pi Ning capsuleXiang Ju Ru Pi Ning capsule (0.45g per capsule ) 4 capsules each time,p.o.,tid,for 3menstrual cycle. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Female patients aged 18 to 50 (including boundary values);
- Those who meet the diagnostic criteria for breast hyperplasia in Western medicine and have a disease course of more than 3 months;
- Meets the traditional Chinese medicine differentiation criteria for liver depression and phlegm coagulation syndrome;
- The BI-RADS grading of the target side breast ultrasound is 2-3 levels, while the BI-RADS grading of the non target side breast ultrasound is 1-3 levels;
- During the screening period, the NRS score is ≥ 4 and there is a target mass detected by palpation;
Key exclusion criteria (12 listed)
- Those who suffer from other breast diseases or breast pain caused by other reasons, such as mastitis, breast cancer, etc;
- Patients with severe cardiovascular, cerebrovascular, liver, kidney, malignant tumors, hematological diseases, and psychiatric disorders;
- Patients who have been previously diagnosed with dysfunctional uterine bleeding, amenorrhea, polycystic ovary syndrome, menopausal syndrome, hyperprolactinemia, Cushing's syndrome, and other diseases and still require treatment by adjusting hormone levels; Individuals who have been diagnosed with diseases that require long-term use of painkillers, such as dysmenorrhea, and are expected to be unable to stop using painkillers during the trial period.
- Abnormal liver function (ALT or AST or ALP or GGT>1.2 times the upper limit of normal values) or abnormal kidney function (serum Cr or BUN or Urea>1.2 times the upper limit of normal values) that the researcher considers clinically significant and is not suitable for participation in clinical trials;
- Women who are in pregnancy, lactation, menopause, or have a pregnancy plan within the past 6 months;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xiang Ju Ru Pi Ning capsule PlaceboAlso: Placebo groupXiang Ju Ru Pi Ning capsule Placebo(0.45g per capsule ) 4 capsules each time,p.o.,tid,for 3menstrual cycle. | Drug | :Xiangjurupining Capsule Placebo group |
| Xiang Ju Ru Pi Ning capsuleAlso: Experimental groupXiang Ju Ru Pi Ning capsule (0.45g per capsule ) 4 capsules each time,p.o.,tid,for 3menstrual cycle. | Drug | Xiangjurupining Capsule Experimental group |
Primary outcome
Pain relief rate
Time frame: Baseline to the 3rd menstrual cycle
Breast pain (NRS score) remission rate from baseline.Subject reported breast pain usingNRs( NumericalRatine Scalelscale onthe subiect daily diary.The NRS scale is a line composed of several points, marked with a scale of 0 to 10.The subjects rated themselves according to the most painful degree every day. The higher the score, the higher the degree of pain.
10 secondary outcomes
Pain disappearance rate
Time frame: Baseline to the 3rd menstrual cycle
Changes in mean NRS scores from baseline within days of pain involvement
Time frame: Baseline to the 3rd menstrual cycle
Changes in maximum NRS scores from baseline
Time frame: Baseline to the 3rd menstrual cycle
Change in pain AUC (area under pain-time curve) from baseline
Time frame: Baseline to the 3rd menstrual cycle
Change from baseline in days with NRS≥4 points
Time frame: Baseline to the 3rd menstrual cycle
Within a few days of pain involvement within a menstrual cycle, the average NRS score decreased by 70% from baseline.
Time frame: Baseline to the 3rd menstrual cycle
TCM syndrome scores
Time frame: the 3rd menstrual cycle after treatment
SF-36V2
Time frame: the 3rd menstrual cycle after treatment
The target lump
Time frame: the 3rd menstrual cycle after treatment
The target lump area
Time frame: the 3rd menstrual cycle after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Xiang Ju Ru Pi Ning capsule in people with Hyperplasia of Mammary Glands, run by Tasly Pharmaceutical Group Co., Ltd at 27 sites 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 8 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rui Liu (022-86343626, liurui2@tasly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain relief rate (time frame: Baseline to the 3rd menstrual cycle). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Nov 2024.