Effects of Xiangshao Granules on Anxiety in Menopausal Women.

NCT05003336 | Unknown Phase 4

• 1 other identifier: XSKL20200422
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 18

Brief 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 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.

Conditions

Anxiety; Menopause

Outcome Measures

Primary Outcomes (1)

• Self-rating Anxiety Scale (SAS) scores change (%)

  % change in SAS scores after 8 weeks of treatment compared with baseline scores

  8 weeks

Secondary Outcomes (11)

• SAS scores change (%)

  4 weeks

• Kupperman scores change (%)

  4 weeks

• Kupperman scores change (%)

  8 weeks

• Self-rating Depression Scale (SDS) scores change (%)

  4 weeks

• SDS scores change (%)

  8 weeks

Study Arms (2)

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

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

Drug: Xiangshao Granules Placebo

Interventions

Xiangshao Granules DRUG

dissolve 1 sachet (4 g) in water to be drank 3 times a day after meal for 8 weeks

Xiangshao Granules

Xiangshao Granules Placebo DRUG

Xiangshao Granules Placebo

Xiangshao Granules Placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• ≤ 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (18)

Anhui Province Maternity & Child Health Hospital

Hefei, Anhui, China

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 010, China

Location

Chongqing Health Center for Women and Children

Chongqing, Chongqing Municipality, China

Location

Gansu Provincial Maternity and Child-care Hospital

Lanzhou, Gansu, China

Location

Cangzhou People's Hospital

Cangzhou, Hebei, China

Location

Second Hospital of Hebei Medical University

Shijiangzhuang, Hebei, China

Location

The First Affiliated Hospital of Henan University

Kaifeng, Henan, China

Location

Zhengzhou Central Hospital Affiliated to Zhengzhou University

Zhengzhou, Henan, China

Location

Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

Jiangsu Province Hospital of Chinese Medicine

Nanjing, Jiangsu, China

Location

Taizhou People's Hospital

Taizhou, Jiangsu, China

Location

Zhangjiagang First People's Hospital

Zhangjiagang, Jiangsu, 0512, China

Location

Jiangxi Maternal and Child Health Hospital

Nanchang, Jiangxi, China

Location

Affiliated Zhongshan Hospital of Dalian University

Dalian, Liaoning, China

Location

Liaocheng People's Hospital

Liaocheng, Shandong, China

Location

Chengdu Women's and Children's Central Hospital

Chengdu, Sichuan, China

Location

School of Clinical medicine & The First Affiliated Hospital of Chengdu Medical College

Chengdu, Sichuan, China

Location

Tianjin Hospital of ITCWM Nankai Hospital

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Rong Chen

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: August 12, 2021
• Study Start: December 23, 2021
• Primary Completion: March 1, 2023
• Study Completion: June 1, 2023
• Last Updated: December 27, 2022

Record last verified: 2022-08

Locations

CN (18)