Menstrual DisordersNCT05312190
Clinical and Basic Researches Related to ZhenQi Buxue Oral Liquid in Treating Menstrual Disorders
A study testing ZhenQi BuXue KouFuYe and Progesterone Capsules in people with Menstrual Disorders, run by Peking Union Medical College Hospital at 2 sites in China.
Trial summary
This study is a national multicenter prospective, randomized, controlled trial, which evaluates Zhenqi Buxue Oral Liquid，Progesterone Capsules and the addition of Zhenqi Buxue Oral Liquid to Progesterone Capsules in the treatment of menstrual disorders in adults women. Read more about this study
- Who is it for?
- Ages 25 to 40 years, women only
- Conditions the study is for
- Menstrual Disorders
- What is being tested?
- ZhenQi BuXue KouFuYe and Progesterone Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 2 sitesChina
- Study dates
- 15 Mar 2022to 30 Jun 2023
- Phase
- Interventional
- 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 25 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Aged between 25 and 40 years old;
- Patients with oligomenorrhea or oligomenorrhea or menopause within three months (see Appendix 1: Diagnostic Criteria of Traditional Chinese and Western Medicine)
- Meet the clinical medication conditions for progesterone to regulate menstruation
- The research subjects were informed and voluntarily participated in this study, and signed the informed consent at the same time.
Who cannot join
- Age <25 years or >40 years old, pregnant or breastfeeding women
- Ovarian dysfunction caused by local ovarian surgery, radiotherapy and chemotherapy for previous malignant tumors, taking hormones or immunosuppressive drugs;
- Combined with serious or unstable physical diseases that may affect the efficacy of drugs and the conduct of trials, including liver, kidney, gastrointestinal, cardiovascular, respiratory, endocrine, neurological, immune or blood system diseases, etc., mental patients .
- Those who were allergic to the drugs used in the trial or had serious adverse reactions in the past;
- Breast cancer or family history of breast cancer in first-degree relatives, irregular vaginal bleeding, uterine fibroids (≥3cm), endometriosis, atypical endometrial hyperplasia, endometrial cancer and other hormone-dependent reproduction Systemic diseases and other malignant tumors;
- Those with a history of thromboembolic disease or thrombosis;
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- Participated in a clinical trial of another research drug within 3 months prior to inclusion in this study (the first interview);
- Those who have used related drugs in the past 3 months or have abused or depended on substances (alcohol or drugs) in the past 3 months; heavy smokers (smokers who smoke 20 or more cigarettes per day);
- Those who met the inclusion criteria, did not follow the doctor's advice, were unable to judge the curative effect or were unable to evaluate the curative effect due to incomplete data.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Lei Li
Beijing, Beijing Municipality, 10000
Lei L Li, MD, 13911988831 ext. ＋86, lileigh@163.com
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 1000730
Aijun Sun, 01018600045466
About this study
This study is a national multicenter prospective, randomized, controlled trial, which evaluates Zhenqi Buxue Oral Liquid，Progesterone Capsules and the addition of Zhenqi Buxue Oral Liquid to Progesterone Capsules in the treatment of menstrual disorders in adults women. One third of participanta will receive Zhenqi Buxue Oral Liquid, one third of participanta will receive Progesterone Capsules, and the another third will receive Zhenqi Buxue Oral Liquid and Progesterone Capsules in combination.
Read the detailed description
Menstrual disorders are one of the most common clinical symptoms in women. Since puberty, about 70% of women have experienced menstrual disorders, including early, delayed, shortened, prolonged, and more importantly oligomenorrhea, amenorrhea, and decreased menstrual flow.At present, the main method of western medicine for the treatment of menstrual disorders is hormone replacement therapy, but the incidence of adverse reactions is high, and the clinical effect is mediocre. Traditional Chinese medicine in my country mostly adopts holistic conditioning therapy for the treatment of irregular menstruation.
Zhenqi Buxue Oral Liquid consists of sheep placenta, pearl, red ginseng, wolfberry, astragalus, angelica, coix seed, ginger and jujube. The excipients are protein sugar and sodium benzoate. Nourishes qi and blood. It is suitable for dizziness, pale complexion, fatigue, lack of energy and lazy words caused by insufficient qi and blood.
This study will conduct a comprehensive and in-depth study on its treatment of mental and psychological stress and menstrual disorders with "oligomenorrhea, amenorrhea, amenorrhea and decreased menstrual flow" as the main manifestations. The molecular mechanism and clinical improvement, and the safety and adverse reactions of its use paln to be clarified.
- Conditions
- Menstrual Disorders
- Being tested
- ZhenQi BuXue KouFuYe, Progesterone Capsules
- Keywords
- Menstrual disorders, Traditional Chinese medicine
- Medical subject headings
- Menstruation Disturbances
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZhenQi BuXue KouFuYeDrug
Zhenqi Buxue Oral Liquid consists of sheep placenta, pearl, red ginseng, wolfberry, astragalus, angelica, coix seed, ginger and jujube. The excipients are protein sugar and sodium benzoate. Nourishes qi and blood. It is suitable for dizziness, pale complexion, fatigue, lack of energy and lazy words caused by insufficient qi and blood.
Progesterone CapsulesDrug
The main ingredient of Progesterone Capsules is abbsolutely progesterone,a kind of hormone,which is the main method of western medicine for the treatment of menstrual disorders
| Study group | Role | What they receive |
|---|---|---|
| Zhenqi Buxue Oral Liquid | Experimental | Zhenqi Buxue Oral Liquid, 10 ml each time, 2 times a day for 3 menstrual cycles, orally Receives: Drug: ZhenQi BuXue KouFuYe |
| Zhenqi Buxue Oral Liquid and Progesterone Capsules | Experimental | Zhenqi Buxue Oral Liquid was taken orally, 10 ml at a time, twice a day for 3 menstrual cycles + orally from the second half of menstrual cycle, Progesterone Capsules 200mg, once a day for 10 days for 3 menstrual cycles Receives: Drug: ZhenQi BuXue KouFuYe; Drug: Progesterone Capsules |
| Progesterone Capsules | Active comparator | Progesterone Capsules 200mg, qd*10 days*3 menstrual cycles, orally Receives: Drug: Progesterone Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menstrual improvement
Menstrual improvement in cycle period
Measured: Within 3 months after the trial complete
Menstrual improvement
Menstrual improvement in menstrual volume
Measured: Within 3 months after the trial complete
Menstrual improvement
Menstrual improvement in number of days with bleeding or spotting
Measured: Within 3 months after the trial complete
Menstrual improvement
Menstrual improvement in monthly rates of amenorrhea
Measured: Within 3 months after the trial complete
Secondary outcomes (3)
Sex hormone levels
mainly FSH, LH，E2 and AMH
Measured: Within 3 months after the trial complete
AFC
Changes in AFC in pelvic ultrasonography
Measured: Within 3 months after the trial complete
SF-36
The change of the MOS item short from health survey
Measured: Within 3 months after the trial complete
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start15 Mar 2022
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual DisordersStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a national multicenter prospective, randomized, controlled trial. One third of participanta will receive Zhenqi Buxue Oral Liquid, one third of participanta will receive Progesterone Capsules, and the another third will receive Zhenqi Buxue Oral Liquid and Progesterone Capsules in combination.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- West China Second University Hospital, Chongqing Medical University No.1 Affiliated Hospital, The Second Hospital of Hebei Medical University, Second Affiliated Hospital of Nanchang University, Zhongda Hospital, Maternal and Child Health Hospital of Hubei Province, Liuzhou Maternity and Child Healthcare Hospital, First Affiliated Hospital of Zhejiang University, Guangzhou Women and Children's Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05312190
- Sponsor's protocol ID
- ZhenQi202201
- Status last verified
- Mar 2022
- First submitted
- 8 Mar 2022
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Basic Researches Related to ZhenQi Buxue Oral Liquid in Treating Menstrual Disorders
- ClinicalTrials.gov ID
- NCT05312190
- Acronym / sponsor ID
- ZhenQi202201
- Conditions
- Menstrual Disorders
- Keywords
- Menstrual disorders, Traditional Chinese medicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- West China Second University Hospital, Chongqing Medical University No.1 Affiliated Hospital, The Second Hospital of Hebei Medical University, Second Affiliated Hospital of Nanchang University, Zhongda Hospital, Maternal and Child Health Hospital of Hubei Province, Liuzhou Maternity and Child Healthcare Hospital, First Affiliated Hospital of Zhejiang University, Guangzhou Women and Children's Medical Center
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 5 Apr 2022 (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 is a national multicenter prospective, randomized, controlled trial, which evaluates Zhenqi Buxue Oral Liquid，Progesterone Capsules and the addition of Zhenqi Buxue Oral Liquid to Progesterone Capsules in the treatment of menstrual disorders in adults women. One third of participanta will receive Zhenqi Buxue Oral Liquid, one third of participanta will receive Progesterone Capsules, and the another third will receive Zhenqi Buxue Oral Liquid and Progesterone Capsules in combination.
Detailed description
Menstrual disorders are one of the most common clinical symptoms in women. Since puberty, about 70% of women have experienced menstrual disorders, including early, delayed, shortened, prolonged, and more importantly oligomenorrhea, amenorrhea, and decreased menstrual flow.At present, the main method of western medicine for the treatment of menstrual disorders is hormone replacement therapy, but the incidence of adverse reactions is high, and the clinical effect is mediocre. Traditional Chinese medicine in my country mostly adopts holistic conditioning therapy for the treatment of irregular menstruation.
Zhenqi Buxue Oral Liquid consists of sheep placenta, pearl, red ginseng, wolfberry, astragalus, angelica, coix seed, ginger and jujube. The excipients are protein sugar and sodium benzoate. Nourishes qi and blood. It is suitable for dizziness, pale complexion, fatigue, lack of energy and lazy words caused by insufficient qi and blood.
This study will conduct a comprehensive and in-depth study on its treatment of mental and psychological stress and menstrual disorders with "oligomenorrhea, amenorrhea, amenorrhea and decreased menstrual flow" as the main manifestations. The molecular mechanism and clinical improvement, and the safety and adverse reactions of its use paln to be clarified.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- This study is a national multicenter prospective, randomized, controlled trial. One third of participanta will receive Zhenqi Buxue Oral Liquid, one third of participanta will receive Progesterone Capsules, and the another third will receive Zhenqi Buxue Oral Liquid and Progesterone Capsules in combination.
| Arm | Type | Receives |
|---|---|---|
| Zhenqi Buxue Oral Liquid | Experimental | Drug: ZhenQi BuXue KouFuYeZhenqi Buxue Oral Liquid, 10 ml each time, 2 times a day for 3 menstrual cycles, orally |
| Zhenqi Buxue Oral Liquid and Progesterone Capsules | Experimental | Drug: ZhenQi BuXue KouFuYe, Drug: Progesterone CapsulesZhenqi Buxue Oral Liquid was taken orally, 10 ml at a time, twice a day for 3 menstrual cycles + orally from the second half of menstrual cycle, Progesterone Capsules 200mg, once a day for 10 days for 3 menstrual cycles |
| Progesterone Capsules | Active comparator | Drug: Progesterone CapsulesProgesterone Capsules 200mg, qd*10 days*3 menstrual cycles, orally |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged between 25 and 40 years old;
- Patients with oligomenorrhea or oligomenorrhea or menopause within three months (see Appendix 1: Diagnostic Criteria of Traditional Chinese and Western Medicine)
- Meet the clinical medication conditions for progesterone to regulate menstruation
- The research subjects were informed and voluntarily participated in this study, and signed the informed consent at the same time.
Key exclusion criteria (9 listed)
- Age <25 years or >40 years old, pregnant or breastfeeding women
- Ovarian dysfunction caused by local ovarian surgery, radiotherapy and chemotherapy for previous malignant tumors, taking hormones or immunosuppressive drugs;
- Combined with serious or unstable physical diseases that may affect the efficacy of drugs and the conduct of trials, including liver, kidney, gastrointestinal, cardiovascular, respiratory, endocrine, neurological, immune or blood system diseases, etc., mental patients .
- Those who were allergic to the drugs used in the trial or had serious adverse reactions in the past;
- Breast cancer or family history of breast cancer in first-degree relatives, irregular vaginal bleeding, uterine fibroids (≥3cm), endometriosis, atypical endometrial hyperplasia, endometrial cancer and other hormone-dependent reproduction Systemic diseases and other malignant tumors;
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 |
|---|---|---|
| ZhenQi BuXue KouFuYeZhenqi Buxue Oral Liquid consists of sheep placenta, pearl, red ginseng, wolfberry, astragalus, angelica, coix seed, ginger and jujube. The excipients are protein sugar and sodium benzoate. Nourishes qi and blood. It is suitable for dizziness, pale complexion, fatigue, lack of energy and lazy words caused by insufficient qi and blood. | Drug | Zhenqi Buxue Oral Liquid, Zhenqi Buxue Oral Liquid and Progesterone Capsules |
| Progesterone CapsulesThe main ingredient of Progesterone Capsules is abbsolutely progesterone,a kind of hormone,which is the main method of western medicine for the treatment of menstrual disorders | Drug | Progesterone Capsules, Zhenqi Buxue Oral Liquid and Progesterone Capsules |
Primary outcome
Menstrual improvement
Time frame: Within 3 months after the trial complete
Menstrual improvement in cycle period
Menstrual improvement
Time frame: Within 3 months after the trial complete
Menstrual improvement in menstrual volume
Menstrual improvement
Time frame: Within 3 months after the trial complete
Menstrual improvement in number of days with bleeding or spotting
Menstrual improvement
Time frame: Within 3 months after the trial complete
Menstrual improvement in monthly rates of amenorrhea
3 secondary outcomes
Sex hormone levels
Time frame: Within 3 months after the trial complete
AFC
Time frame: Within 3 months after the trial complete
SF-36
Time frame: Within 3 months after the trial complete
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ZhenQi BuXue KouFuYe and Progesterone Capsules in people with Menstrual Disorders, run by Peking Union Medical College Hospital at 2 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 4 inclusion and 9 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 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menstrual improvement (time frame: Within 3 months after the trial complete). The study lists 4 primary outcomes in all. 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 5 Apr 2022.