AnxietyPhase 4NCT05003336
Effects of Xiangshao Granules on Anxiety in Menopausal Women.
A Phase 4 study testing Xiangshao Granules in people with Anxiety and Menopause, run by Peking Union Medical College Hospital at 18 sites in China.
Trial summary
Symptoms of anxiety are prevalent during the menopausal transition and early postmenopause. These symptoms are mainly improved by anti-anxiety agents, which are associated with some adverse effects including dizziness, sleepiness, and constipation and not all patients respond to currently available pharmacological… Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- What is being tested?
- Xiangshao Granules
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 18 sitesChina
- Study dates
- 23 Dec 2021to 8 Jun 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 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- meet the diagnostic criteria for menopause syndrome (age 40-65 years, being in the menopausal transition stage or postmenopausal stage determined according to the 2011 Stages of Reproductive Aging Workshop +10 criteria).
- 50 ≤ SAS scores ≤ 69.
- improved Kupperman scores ≥16.
- has an intact uterus and at least one ovary.
- able and willing to participate in study and provide written informed consent, and agrees to follow all study requirements. The investigator consider the subject able to complete the study.
Who cannot join
- history of allergy or sensitivity to investigational product.
- currently or historically taking medication or psychotherapy for menopause anxiety in the past 4 weeks, including but not limited to estrogens, oestrogen-like hormone, Chinese medicine or health care products used to relieve anxiety (such as soy isoflavones, vitamin E, black cohosh), anti-anxiety agents, antidepressants, mood stabilizers, sedatives.
- anxiety or other psychiatric disease unrelated to menopause (eg., currently or previously diagnosed as major depression, acute panic disorder, obsessive-compulsive disorder, phobia, hypochondria, mood disorder or schizophrenia or psychiatric diseases caused by other psychoactive substances or organic diseases), anxiety symptoms caused by stress, suicidal tendency, alcohol or drug dependence, etc.
- having major depression as defined by a SDS score≥70 at screening.
- systemic disease (eg., hypothyroidism/hyperthyroidism, unstable coronary heart disease, severe hypertension [sbp≥180mmHg and/or dbp≥110mmHg] or pheochromocytoma).
- definite diagnosis of endometrial cancer, cervical cancer, ovarian cancer and other gynecological malignancies, as well as breast cancer.
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- severe liver or kidney diseases (eg., alanine aminotransferase[ALT]/aspartate aminotransferase[AST]/serum creatinine[Scr] levels 2 times greater than the upper limit of normal) or severe primary diseases in cardiovascular, cerebrovascular, liver, kidney and hematopoietic system.
- participated in other clinical trials within the last 3 months.
- lactating or pregnant women, or plan to become pregnant during study or not agree to use reliable contraceptive methods throughout the study period.
- other reasons the investigator consider the patient may not be suitable for the study.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
China18 sites
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 010
Cangzhou People's Hospital
Cangzhou, Hebei
Second Xiangya Hospital of Central South University
Changsha, Hunan
Chengdu Women's and Children's Central Hospital
Chengdu, Sichuan
School of Clinical medicine & The First Affiliated Hospital of Chengdu Medical College
Chengdu, Sichuan
Chongqing Health Center for Women and Children
Chongqing, Chongqing Municipality
Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning
Anhui Province Maternity & Child Health Hospital
Hefei, Anhui
The First Affiliated Hospital of Henan University
Kaifeng, Henan
Gansu Provincial Maternity and Child-care Hospital
Lanzhou, Gansu
Liaocheng People's Hospital
Liaocheng, Shandong
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi
Jiangsu Province Hospital of Chinese Medicine
Nanjing, Jiangsu
Second Hospital of Hebei Medical University
Shijiangzhuang, Hebei
Taizhou People's Hospital
Taizhou, Jiangsu
Tianjin Hospital of ITCWM Nankai Hospital
Tianjin, Tianjin Municipality
Zhangjiagang First People's Hospital
Zhangjiagang, Jiangsu, 0512
Zhengzhou Central Hospital Affiliated to Zhengzhou University
Zhengzhou, Henan
About this study
Official title: Effects of Xiangshao Granules on Anxiety in Menopausal Women: A Multicenter, Randomized, Double-blind, Placebo-controlled Study.
Symptoms of anxiety are prevalent during the menopausal transition and early postmenopause. These symptoms are mainly improved by anti-anxiety agents, which are associated with some adverse effects including dizziness, sleepiness, and constipation and not all patients respond to currently available pharmacological treatments, thus novel agents with fewer side effects are needed. Some studies have shown that traditional Chinese medicine can alleviate menopausal symptoms safely and economically, and improve quality of life. Xiangshao granules reportedly have good curative effects on menopausal symptoms and premenstrual syndrome and exhibit good safety. This study aim to evaluate the efficacy and safety of Xiangshao granule in improving anxiety state of women with menopause syndrome.
- Being tested
- Xiangshao Granules, Xiangshao Granules Placebo
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xiangshao GranulesDrug
dissolve 1 sachet (4 g) in water to be drank 3 times a day after meal for 8 weeks
Xiangshao Granules PlaceboDrug
Xiangshao Granules Placebo
| Study group | Role | What they receive |
|---|---|---|
| Xiangshao Granules | Experimental | dissolve 1 sachet (4 g) of Xiangshao Granules in water to be drank 3 times a day after meal for 8 weeks Receives: Drug: Xiangshao Granules |
| Xiangshao Granules Placebo | Placebo comparator | dissolve 1 sachet (4 g) of Xiangshao Granules placebo in water to be drank 3 times a day after meal for 8 weeks Receives: Drug: Xiangshao Granules Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-rating Anxiety Scale (SAS) scores change (%)
% change in SAS scores after 8 weeks of treatment compared with baseline scores
Measured: 8 weeks
Secondary outcomes (11)
SAS scores change (%)
% change in SAS scores after 4 weeks of treatment compared with baseline scores
Measured: 4 weeks
Kupperman scores change (%)
% change in Kupperman scores after 4 weeks of treatment compared with baseline scores
Measured: 4 weeks
Kupperman scores change (%)
% change in Kupperman scores after 8 weeks of treatment compared with baseline scores
Measured: 8 weeks
Self-rating Depression Scale (SDS) scores change (%)
% change in SDS scores after 4 weeks of treatment compared with baseline scores
Measured: 4 weeks
SDS scores change (%)
% change in SDS scores after 8 weeks of treatment compared with baseline scores
Measured: 8 weeks
serum Follicle Stimulating Hormone (FSH) level
change in serum FSH level after 4 weeks of treatment compared with baseline
Measured: 4 weeks
serum FSH level
change in serum FSH level after 8 weeks of treatment compared with baseline
Measured: 8 weeks
serum estradiol (E2) level
change in serum estradiol(E2) level after 4 weeks of treatment compared with baseline
Measured: 4 weeks
serum estradiol (E2) level
change in serum estradiol(E2) level after 8 weeks of treatment compared with baseline
Measured: 8 weeks
gastrointestinal symptom score (GIS) change (%)
% change in GIS after 4 weeks of treatment compared with baseline scores
Measured: 4 weeks
gastrointestinal symptom score (GIS) change (%)
% change in GIS after 8 weeks of treatment compared with baseline scores
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start23 Dec 2021
- Primary completion8 Jun 2023
- Study completion8 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rong Chen, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05003336
- Sponsor's protocol ID
- XSKL20200422
- Status last verified
- Aug 2022
- First submitted
- 10 Aug 2021
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Xiangshao Granules on Anxiety in Menopausal Women: A Multicenter, Randomized, Double-blind, Placebo-controlled Study.
- ClinicalTrials.gov ID
- NCT05003336
- Acronym / sponsor ID
- XSKL20200422
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 23 Dec 2021 (actual)
- Primary completion
- 8 Jun 2023 (actual)
- Study completion
- 8 Jun 2023 (actual)
- First posted
- 12 Aug 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.
Symptoms of anxiety are prevalent during the menopausal transition and early postmenopause. These symptoms are mainly improved by anti-anxiety agents, which are associated with some adverse effects including dizziness, sleepiness, and constipation and not all patients respond to currently available pharmacological treatments, thus novel agents with fewer side effects are needed. Some studies have shown that traditional Chinese medicine can alleviate menopausal symptoms safely and economically, and improve quality of life. Xiangshao granules reportedly have good curative effects on menopausal symptoms and premenstrual syndrome and exhibit good safety. This study aim to evaluate the efficacy and safety of Xiangshao granule in improving anxiety state of women with menopause syndrome.
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 |
|---|---|---|
| Xiangshao Granules | Experimental | Drug: Xiangshao Granulesdissolve 1 sachet (4 g) of Xiangshao Granules in water to be drank 3 times a day after meal for 8 weeks |
| Xiangshao Granules Placebo | Placebo comparator | Drug: Xiangshao Granules Placebodissolve 1 sachet (4 g) of Xiangshao Granules placebo in water to be drank 3 times a day after meal for 8 weeks |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- meet the diagnostic criteria for menopause syndrome (age 40-65 years, being in the menopausal transition stage or postmenopausal stage determined according to the 2011 Stages of Reproductive Aging Workshop +10 criteria).
- 50 ≤ SAS scores ≤ 69.
- improved Kupperman scores ≥16.
- has an intact uterus and at least one ovary.
- able and willing to participate in study and provide written informed consent, and agrees to follow all study requirements. The investigator consider the subject able to complete the study.
Key exclusion criteria (10 listed)
- history of allergy or sensitivity to investigational product.
- currently or historically taking medication or psychotherapy for menopause anxiety in the past 4 weeks, including but not limited to estrogens, oestrogen-like hormone, Chinese medicine or health care products used to relieve anxiety (such as soy isoflavones, vitamin E, black cohosh), anti-anxiety agents, antidepressants, mood stabilizers, sedatives.
- anxiety or other psychiatric disease unrelated to menopause (eg., currently or previously diagnosed as major depression, acute panic disorder, obsessive-compulsive disorder, phobia, hypochondria, mood disorder or schizophrenia or psychiatric diseases caused by other psychoactive substances or organic diseases), anxiety symptoms caused by stress, suicidal tendency, alcohol or drug dependence, etc.
- having major depression as defined by a SDS score≥70 at screening.
- systemic disease (eg., hypothyroidism/hyperthyroidism, unstable coronary heart disease, severe hypertension [sbp≥180mmHg and/or dbp≥110mmHg] or pheochromocytoma).
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 |
|---|---|---|
| Xiangshao Granulesdissolve 1 sachet (4 g) in water to be drank 3 times a day after meal for 8 weeks | Drug | Xiangshao Granules |
| Xiangshao Granules PlaceboXiangshao Granules Placebo | Drug | Xiangshao Granules Placebo |
Primary outcome
Self-rating Anxiety Scale (SAS) scores change (%)
Time frame: 8 weeks
% change in SAS scores after 8 weeks of treatment compared with baseline scores
11 secondary outcomes
SAS scores change (%)
Time frame: 4 weeks
Kupperman scores change (%)
Time frame: 4 weeks
Kupperman scores change (%)
Time frame: 8 weeks
Self-rating Depression Scale (SDS) scores change (%)
Time frame: 4 weeks
SDS scores change (%)
Time frame: 8 weeks
serum Follicle Stimulating Hormone (FSH) level
Time frame: 4 weeks
serum FSH level
Time frame: 8 weeks
serum estradiol (E2) level
Time frame: 4 weeks
serum estradiol (E2) level
Time frame: 8 weeks
gastrointestinal symptom score (GIS) change (%)
Time frame: 4 weeks
gastrointestinal symptom score (GIS) change (%)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
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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.
Rong Chen principal investigator
Peking Union Medical College Hospital
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Xiangshao Granules in people with Anxiety and Menopause, run by Peking Union Medical College Hospital at 18 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 5 inclusion and 10 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 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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 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?
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?
Self-rating Anxiety Scale (SAS) scores change (%) (time frame: 8 weeks). 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 3 Nov 2026.