EndometriosisPhase 4NCT04942015
Honghuaruyi Wan for Endometriosis Dysmenorrhea
A Phase 4 study testing Honghuaruyi Wan in people with Endometriosis and Dysmenorrhea, run by Beijing University of Chinese Medicine.
Trial summary
Endometriosis is a common gynecological disease. It is a gynecological disease caused by the growth and reproduction of the endometrium beyond the surface of the uterine tissue and organs, which causes recurrent abdominal pain, infertility and other main symptoms. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis, Dysmenorrhea
- What is being tested?
- Honghuaruyi Wan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 164 participants
- Where
- No sites listed yet
- Study dates
- 21 Jun 2021to 31 Dec 2023
- Phase
- Phase 4
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Meet the diagnostic criteria for endometriosis and have dysmenorrhea VAS score ≥4 points;
- Age 18 to 45;
- Regular menstrual cycle (28±7 days);
- Not pregnant at the time of seeing a doctor and no pregnancy plan during the medication, can insist on contraception;
- No pelvic nodules or adnexal masses, or pelvic nodules or adnexal masses ≤4cm;
- CA125 is normal or slightly elevated (below 200U/ml).
- Patients who voluntarily signed the informed consent and had conditional follow-up.
Who cannot join
- Patients who have known to have malignancies of reproductive organs or other malignancies;
- Suffering from serious diseases or mental diseases such as cardiovascular, cerebrovascular, liver, kidney or hematopoietic system;
- Uterine fibroids (≥3cm) and adenomyosis (uterine over 6 weeks of gestation, the reference value of uterine tridiameter at 6 weeks is 12cm, 7.5cm, 4.5cm);
- Those who received hormone drug therapy within 3 months before enrollment;
- lactating patients.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Beijing University of Chinese Medicine
Endometriosis is a common gynecological disease. It is a gynecological disease caused by the growth and reproduction of the endometrium beyond the surface of the uterine tissue and organs, which causes recurrent abdominal pain, infertility and other main symptoms.
The recurrence of endometriosis and the side effects of medication have troubled clinicians and patients for a long time and the search for new drugs is going on all the time. Honghuaruyi Wan is the traditional Tibetan prescription, clinical research has proved that Honghuaruyi Wan can significantly reduce risk mouse dysmenorrhea caused by oxytocin, improve dysmenorrhea model of mice body torsion times and improve the estrogen and progestogen operator Netherlands rat pituitary estradiol and prolactin level, at the same time also can reduce the amount of TNF alpha, thus improving endometriosis dysmenorrhea.
In this study, the therapeutic effects of Honghuaruyi Wan provided by Tibet Qizheng Tibetan Medicine Co.,Ltd on secondary dysmenorrhea in patients with endometriosis was evaluated clinically. A multi-center, randomized, double-blind, placebo-controlled clinical trial was designed to provide evidence-based medical evidence for Honghuaruyi Wan in the treatment of endometriosis dysmenorrhea. In the design of this trial, the therapeutic effects and safety of Honghuaruyi Wan in the treatment of dysmenorrhea secondary to endometriosis were evaluated with Honghuaruyi Wan in the treatment group and placebo in the control group.
Read the detailed description
Endometriosis (EM) is a common gynecological disease at present. It is a gynecological disease caused by the growth and reproduction of the endometrium on the surface of tissues and organs beyond the uterine covering surface, resulting in recurrent abdominal pain and infertility. The pathogenesis of endometriosis may be related to female endocrine dysfunction and abnormal levels of estrogen and progesterone in the body. Its clinical symptoms mainly include dysmenorrhea, chronic pelvic pain and sexual pain.
The recurrence of endometriosis and the side effects of medication have troubled clinicians and patients for a long time. The search for new drugs has been going on.
Honghuaruyi Wan is a traditional Tibetan prescription, which is made by addition and subtraction on the basis of the traditional and classic Tibetan medicine prescription "25 Wei Guijiu Wan". Its main ingredients are: Honghua,Xihonghua,Taoerqi,Kezi,Zangqiancao,Rougui,Baxiaga,Zangmuxiang,Yuansuiguo,Jiangxiang,Xiongdanfen,Zangzicao,Guangmingyan,Ximalayazimoli,Bangga,Hujiao,Huasherou,Aizijin,Yuganzi,Shajigao,Naosha,Zicaorong,Gouqizi,Chenxiang,Huoxiao. It has the effects of dispelling wind-evil and relieving pain, regulating menstrual blood and removing spots. It can be used for vaginitis, cervical erosion, irregular menstruation, dysmenorrhea and other common gynecological diseases. The main medicinal ingredients of Honghuaruyi Wan are Honghua ,Taoerqi and Zanghonghua, which have the effects of relieving pain, regulating menstruation and blood and dispersing knots. Some clinical studies have shown that the basic prescription of Honghuaruyi Wan have a significant effect on the improvement of dysmenorrhea, which can significantly reduce the incidence of dysmenorrhea caused by oxytocin in mice, and improve the number of body twisting in dysmenorrhea model mice. Other clinical studies have shown that Honghuaruyi Wan can improve estradiol and prolactin levels of pituitary gland in rats with estrogen and progesterone, as well as reduce TNF-α levels, thus improving endometriosis dysmenorrhea.
For women of childbearing age who do not have fertility requirements, pain is the most important clinical symptom that needs to be addressed, especially with progressive dysmenorrhea. Therefore, in this study, the therapeutic effects of Honghuaruyi Wan, provided by Tibet Qizheng Tibetan Medicine Co.,Ltd, on the secondary dysmenorrhea of patients with endometriosis was evaluated clinically. A multi-center, randomized, double-blind, placebo-controlled clinical trial was designed to provide evidence-based medical evidence for Honghuaruyi Wan in the treatment of endometriosis dysmenorrhea.
In the design of this trial, the therapeutic effects and safety of Honghuaruyi Wan in the treatment of dysmenorrhea secondary to endometriosis were evaluated with Honghuaruyi Wan in the treatment group and placebo in the control group.
- Conditions
- Endometriosis, Dysmenorrhea
- Being tested
- Honghuaruyi Wan, Placebo of Honghuaruyi Wan
- Medical subject headings
- Endometriosis, Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Honghuaruyi WanDrug
Honghuaruyi Wan is the traditional Tibetan prescription, clinical research has proved that Honghuaruyi Wan can significantly reduce risk mouse dysmenorrhea caused by oxytocin, improve dysmenorrhea model of mice body torsion times and improve the estrogen and progestogen operator Netherlands rat pituitary estradiol and prolactin level, at the same time also can reduce the amount of TNF alpha, thus improving endometriosis dysmenorrhea.(Pill (15 pills/plate ×2 plates/box))
Placebo of Honghuaruyi WanDrug
Honghuaruyi Wan simulation agent. Made of starch,dextrin and edible pigment from Tibet Qizheng Tibetan Medicine Co.,Ltd. ( Pill (15 pills/plate ×2 plates/box))
| Study group | Role | What they receive |
|---|---|---|
| Honghuaruyi Wan | Experimental | Honghuaruyi Wan will be used in this arm. Patients should start taking medicine with warm water on the first day of menstruation. For patients with VAS score < 7 points, 1g / time, twice a day; for patients with VAS score ≥ 7 points and pain is hard to bear, 2g / time, twice a day. According to the above usage and dosage, take 3 menstrual cycles continuously, and observe 3 menstrual cycles after stopping the drug. Receives: Drug: Honghuaruyi Wan |
| Placebo | Placebo comparator | Placebo of Honghuaruyi Wan will be used in this arm. Patients should start taking medicine with warm water on the first day of menstruation. For patients with VAS score < 7 points, 1g / time, twice a day; for patients with VAS score ≥ 7 points and pain is hard to bear, 2g / time, twice a day. According to the above usage and dosage, take 3 menstrual cycles continuously, and observe 3 menstrual cycles after stopping the drug. Receives: Drug: Placebo of Honghuaruyi Wan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale/Score (VAS)
Draw a horizontal line of 10 cm on the paper. One end of the horizontal line is 0, indicating no pain.The other end is 10, which means severe pain; The part between the two ends represents different levels of pain. A higher score means a worse outcome.
Measured: Baseline through 6th consecutive menstrual cycle. (One cycle = 28±7days)
Endometriosis Health Profle-5（EHP-5）
The core questionnaire contains 5 questions，every question has 5 answers：Never=0，Very few=1，Sometimes=2，Often=3，Always=4. The minimum and maximum values are between 0 to 20 and a higher value means a worse outcome.
Measured: Baseline through 6th consecutive menstrual cycle. (One cycle = 28±7days)
The 5-level EQ-5D version（EQ-5D-5L）
There are 6 questions in the scale，the first 5 questions has 5 answers：No=0， A little bit=1， Moderate=2， Serious=3 Very serious=4. The minimum and maximum values are between 0 to 20 and a higher value means a worse outcome. The 6th question is about the status of the day visited. The minimum and maximum scores are between 0 to 100 and a higher value means a better outcome.
Measured: Baseline through 6th consecutive menstrual cycle. (One cycle = 28±7days)
Secondary outcomes (5)
Visual Analogue Scale/Score (VAS) of the maximum non-menstrual pelvic pain
Draw a horizontal line of 10 cm on the paper. One end of the horizontal line is 0, indicating no pain.The other end is 10, which means severe pain; The part between the two ends represents different levels of pain. A higher score means a worse outcome.
Measured: Baseline through 6th consecutive menstrual cycle. (One cycle = 28±7days)
The number of ibuprofen sustained-release capsules (or other NSAIDs) used
The number of ibuprofen sustained-release capsules (or other NSAIDs) used
Measured: Baseline through 6th consecutive menstrual cycle. (One cycle = 28±7days)
Number of days off for staff/students due to dysmenorrhea
Number of days off for staff/students due to dysmenorrhea
Measured: Baseline through 6th consecutive menstrual cycle. (One cycle = 28±7days)
The maximum diameter of the uterus
The diameter of the uterus will be measured by B ultrasonic
Measured: Baseline, After treatment (3rd menstrual cycle). (One cycle = 28±7days)
The maximum diameter of the cysts
The diameter of the cysts will be measured by B ultrasonic
Measured: Baseline, After treatment (3rd menstrual cycle). (One cycle = 28±7days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start21 Jun 2021 (estimated)
- Primary completion31 May 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mei han, Beijing University of Chinese Medicine
- Investigators
- Mei Han, Study chair, Centre for Evidence-based Chinese Medicine, Beijing University of Chinese Medicne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04942015
- Sponsor's protocol ID
- HHRYW2021-05
- Status last verified
- Jun 2021
- First submitted
- 27 May 2021
- Last updated
- 28 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data sharing plans for the current study are limited upon to contract with the company and might be made available upon agreement from the company.
Publications
Han M, Liang XF, Gao J, Wang Y, Cao LX, Wang BJ, Wang Y, Zhuoma Z, Liu JP, Du HL. Honghua Ruyi Pill, a compound herbal medicine, improves endometriosis-related dysmenorrhea: A multicenter randomized, double-blind, placebo-controlled trial. J Integr Med. 2026 Mar;24(2):182-191. doi: 10.1016/j.joim.2025.12.011. Epub 2025 Dec 29.
PubMed 41529972
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beijing University of Chinese Medicine
- ClinicalTrials.gov ID
- NCT04942015
- Acronym / sponsor ID
- HHRYW2021-05
- Conditions
- Endometriosis, Dysmenorrhea
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Beijing University of Chinese MedicineUniversity, hospital or other
- Study start
- 21 Jun 2021 (estimated)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 28 Jun 2021 (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.
Endometriosis is a common gynecological disease. It is a gynecological disease caused by the growth and reproduction of the endometrium beyond the surface of the uterine tissue and organs, which causes recurrent abdominal pain, infertility and other main symptoms.
The recurrence of endometriosis and the side effects of medication have troubled clinicians and patients for a long time and the search for new drugs is going on all the time. Honghuaruyi Wan is the traditional Tibetan prescription, clinical research has proved that Honghuaruyi Wan can significantly reduce risk mouse dysmenorrhea caused by oxytocin, improve dysmenorrhea model of mice body torsion times and improve the estrogen and progestogen operator Netherlands rat pituitary estradiol and prolactin level, at the same time also can reduce the amount of TNF alpha, thus improving endometriosis dysmenorrhea.
In this study, the therapeutic effects of Honghuaruyi Wan provided by Tibet Qizheng Tibetan Medicine Co.,Ltd on secondary dysmenorrhea in patients with endometriosis was evaluated clinically. A multi-center, randomized, double-blind, placebo-controlled clinical trial was designed to provide evidence-based medical evidence for Honghuaruyi Wan in the treatment of endometriosis dysmenorrhea. In the design of this trial, the therapeutic effects and safety of Honghuaruyi Wan in the treatment of dysmenorrhea secondary to endometriosis were evaluated with Honghuaruyi Wan in the treatment group and placebo in the control group.
Detailed description
Endometriosis (EM) is a common gynecological disease at present. It is a gynecological disease caused by the growth and reproduction of the endometrium on the surface of tissues and organs beyond the uterine covering surface, resulting in recurrent abdominal pain and infertility. The pathogenesis of endometriosis may be related to female endocrine dysfunction and abnormal levels of estrogen and progesterone in the body. Its clinical symptoms mainly include dysmenorrhea, chronic pelvic pain and sexual pain.
The recurrence of endometriosis and the side effects of medication have troubled clinicians and patients for a long time. The search for new drugs has been going on.
Honghuaruyi Wan is a traditional Tibetan prescription, which is made by addition and subtraction on the basis of the traditional and classic Tibetan medicine prescription "25 Wei Guijiu Wan". Its main ingredients are: Honghua,Xihonghua,Taoerqi,Kezi,Zangqiancao,Rougui,Baxiaga,Zangmuxiang,Yuansuiguo,Jiangxiang,Xiongdanfen,Zangzicao,Guangmingyan,Ximalayazimoli,Bangga,Hujiao,Huasherou,Aizijin,Yuganzi,Shajigao,Naosha,Zicaorong,Gouqizi,Chenxiang,Huoxiao. It has the effects of dispelling wind-evil and relieving pain, regulating menstrual blood and removing spots. It can be used for vaginitis, cervical erosion, irregular menstruation, dysmenorrhea and other common gynecological diseases. The main medicinal ingredients of Honghuaruyi Wan are Honghua ,Taoerqi and Zanghonghua, which have the effects of relieving pain, regulating menstruation and blood and dispersing knots. Some clinical studies have shown that the basic prescription of Honghuaruyi Wan have a significant effect on the improvement of dysmenorrhea, which can significantly reduce the incidence of dysmenorrhea caused by oxytocin in mice, and improve the number of body twisting in dysmenorrhea model mice. Other clinical studies have shown that Honghuaruyi Wan can improve estradiol and prolactin levels of pituitary gland in rats with estrogen and progesterone, as well as reduce TNF-α levels, thus improving endometriosis dysmenorrhea.
For women of childbearing age who do not have fertility requirements, pain is the most important clinical symptom that needs to be addressed, especially with progressive dysmenorrhea. Therefore, in this study, the therapeutic effects of Honghuaruyi Wan, provided by Tibet Qizheng Tibetan Medicine Co.,Ltd, on the secondary dysmenorrhea of patients with endometriosis was evaluated clinically. A multi-center, randomized, double-blind, placebo-controlled clinical trial was designed to provide evidence-based medical evidence for Honghuaruyi Wan in the treatment of endometriosis dysmenorrhea.
In the design of this trial, the therapeutic effects and safety of Honghuaruyi Wan in the treatment of dysmenorrhea secondary to endometriosis were evaluated with Honghuaruyi Wan in the treatment group and placebo in the control group.
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 |
|---|---|---|
| Honghuaruyi Wan | Experimental | Drug: Honghuaruyi WanHonghuaruyi Wan will be used in this arm. Patients should start taking medicine with warm water on the first day of menstruation. For patients with VAS score < 7 points, 1g / time, twice a day; for patients with VAS score ≥ 7 points and pain is hard to bear, 2g / time, twice a day. According to the above usage and dosage, take 3 menstrual cycles continuously, and observe 3 menstrual cycles after stopping the drug. |
| Placebo | Placebo comparator | Drug: Placebo of Honghuaruyi WanPlacebo of Honghuaruyi Wan will be used in this arm. Patients should start taking medicine with warm water on the first day of menstruation. For patients with VAS score < 7 points, 1g / time, twice a day; for patients with VAS score ≥ 7 points and pain is hard to bear, 2g / time, twice a day. According to the above usage and dosage, take 3 menstrual cycles continuously, and observe 3 menstrual cycles after stopping the drug. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Meet the diagnostic criteria for endometriosis and have dysmenorrhea VAS score ≥4 points;
- Age 18 to 45;
- Regular menstrual cycle (28±7 days);
- Not pregnant at the time of seeing a doctor and no pregnancy plan during the medication, can insist on contraception;
- No pelvic nodules or adnexal masses, or pelvic nodules or adnexal masses ≤4cm;
Key exclusion criteria (5 listed)
- Patients who have known to have malignancies of reproductive organs or other malignancies;
- Suffering from serious diseases or mental diseases such as cardiovascular, cerebrovascular, liver, kidney or hematopoietic system;
- Uterine fibroids (≥3cm) and adenomyosis (uterine over 6 weeks of gestation, the reference value of uterine tridiameter at 6 weeks is 12cm, 7.5cm, 4.5cm);
- Those who received hormone drug therapy within 3 months before enrollment;
- lactating patients.
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 |
|---|---|---|
| Honghuaruyi WanHonghuaruyi Wan is the traditional Tibetan prescription, clinical research has proved that Honghuaruyi Wan can significantly reduce risk mouse dysmenorrhea caused by oxytocin, improve dysmenorrhea model of mice body torsion times and improve the estrogen and progestogen operator Netherlands rat pituitary estradiol and prolactin level, at the same time also can reduce the amount of TNF alpha, thus improving endometriosis dysmenorrhea.(Pill (15 pills/plate ×2 plates/box)) | Drug | Honghuaruyi Wan |
| Placebo of Honghuaruyi WanHonghuaruyi Wan simulation agent. Made of starch,dextrin and edible pigment from Tibet Qizheng Tibetan Medicine Co.,Ltd. ( Pill (15 pills/plate ×2 plates/box)) | Drug | Placebo |
Primary outcome
Visual Analogue Scale/Score (VAS)
Time frame: Baseline through 6th consecutive menstrual cycle. (One cycle = 28±7days)
Draw a horizontal line of 10 cm on the paper. One end of the horizontal line is 0, indicating no pain.The other end is 10, which means severe pain; The part between the two ends represents different levels of pain. A higher score means a worse outcome.
Endometriosis Health Profle-5（EHP-5）
Time frame: Baseline through 6th consecutive menstrual cycle. (One cycle = 28±7days)
The core questionnaire contains 5 questions，every question has 5 answers：Never=0，Very few=1，Sometimes=2，Often=3，Always=4. The minimum and maximum values are between 0 to 20 and a higher value means a worse outcome.
The 5-level EQ-5D version（EQ-5D-5L）
Time frame: Baseline through 6th consecutive menstrual cycle. (One cycle = 28±7days)
There are 6 questions in the scale，the first 5 questions has 5 answers：No=0， A little bit=1， Moderate=2， Serious=3 Very serious=4. The minimum and maximum values are between 0 to 20 and a higher value means a worse outcome. The 6th question is about the status of the day visited. The minimum and maximum scores are between 0 to 100 and a higher value means a better outcome.
5 secondary outcomes
Visual Analogue Scale/Score (VAS) of the maximum non-menstrual pelvic pain
Time frame: Baseline through 6th consecutive menstrual cycle. (One cycle = 28±7days)
The number of ibuprofen sustained-release capsules (or other NSAIDs) used
Time frame: Baseline through 6th consecutive menstrual cycle. (One cycle = 28±7days)
Number of days off for staff/students due to dysmenorrhea
Time frame: Baseline through 6th consecutive menstrual cycle. (One cycle = 28±7days)
The maximum diameter of the uterus
Time frame: Baseline, After treatment (3rd menstrual cycle). (One cycle = 28±7days)
The maximum diameter of the cysts
Time frame: Baseline, After treatment (3rd menstrual cycle). (One cycle = 28±7days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2021.
- Derived from this study: PubMed 41529972Han M, Liang XF, Gao J, Wang Y, Cao LX, Wang BJ, Wang Y, Zhuoma Z, Liu JP, Du HL. Honghua Ruyi Pill, a compound herbal medicine, improves endometriosis-related dysmenorrhea: A multicenter randomized, double-blind, placebo-controlled trial. J Integr Med. 2026 Mar;24(2):182-191. doi: 10.1016/j.joim.2025.12.011. Epub 2025 Dec 29.
- Individual participant dataSharing planned: No. The data sharing plans for the current study are limited upon to contract with the company and might be made available upon agreement from the company.
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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. This study is not recruiting at the moment.
Mei Han study chair
Centre for Evidence-based Chinese Medicine, Beijing University of Chinese Medicne
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Honghuaruyi Wan in people with Endometriosis and Dysmenorrhea, run by Beijing University of Chinese Medicine.
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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 28 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mei Han (+86 10 64287002, hanmeizoujin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale/Score (VAS) (time frame: Baseline through 6th consecutive menstrual cycle. (One cycle = 28±7days)). The study lists 3 primary outcomes in all. 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 NCT04942015, which also lists 1 linked publication.
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 Jun 2021.