Comparison Study for Perimenopausal Syndrome With Chinese Herbal Medicine

NCT05266079 | Completed

• 1 other identifier: CSPSCHM
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Perimenopausal syndrome (PMS) refers to a series of symptoms caused by the dynamic fluctuations of sex hormones during menopause. Menopausal symptoms including hot flushes, vaginal dryness and mood swings are experienced by about 80% of Chinese women aged 45 to 60. In the past year, 235 patients visited CMCTR(ND), a TCM center set up by HA and operated by HKFTU Workers' Medical Clinics since 2008, suffered from PMS. According to literature review, high proportion of clinical trials regarding perimenopausal women used fixed formula treatment. However, different constitutional types were found in perimenopausal women and different fixed formulae were used in different research. Apart from kidney yin deficiency, perimenopausal women were also found in liver-kidney yin deficiency, kidney yang deficiency, kidney yin and yang deficiency, disharmony between heart and kidney, liver qi stagnation, etc. It is difficult to draw a conclusion that any single fixed formula could have the best efficacy on PMS. Therefore, it is worth studying to see whether syndrome differentiation would be a better choice for PMS treatment. Objective: The study aims to evaluate whether syndrome differentiated treatment is better than fixed formula (Er-Xian decoction) treatment for perimenopausal women. Design: This is a pilot single-blinded, randomized controlled trial. Participants: Chinese women aged 45-55 year with menstruation abnormalities (menstrual irregularity in past 12 months; or menstrual period off at least twice in past 12 months; or amenorrhea of 2 to 12 months); also suffering any following perimenopausal symptoms: vasomotor symptoms (hot flushes, sweats), psychological symptoms (insomnia, migraine, irritability), or genitourinary symptoms (vaginal dryness, dyspareunia) Interventions: A randomized controlled trial will be conducted to assess the efficacy of syndrome differentiated treatment versus a fixed formula (Er-Xian decoction) in treating PMS. 100 participants will be randomly divided into 2 groups. Intervention group of participants will be given medication by syndrome differentiating from qualified TCM Practitioners while the control group of participants will be given a fixed formula. Outcome measures: Primary assessments outcome measure is the Kupperman Index, and the secondary outcome measure is MENQOL questionnaire.

Conditions

Menopausal Syndrome

Outcome Measures

Primary Outcomes (1)

• Kupperman Index

  The evaluation is based on the clinical research experience of Kupperman HS in 1950s, which is composed of patient self-report and physician rating. The questionnaire includes 11 climacteric symptoms. The degree of symptoms was divide into four grades ranged from 0 to III: 0 for asymptomatic, I for occasional symptoms, II for frequent symptoms, and III for serious impact of life. These ratings were then summed across the 11 items and the score was categorized as follows: none 0-5, mild 5-10, moderate 10-15, severe 15+.

  8 weeks

Secondary Outcomes (1)

• Menopause Specific Quality of Life

  0,2,4,6,8,10,16 week

Study Arms (2)

Syndrome differentiation treatment(GMBHDHT, TWBXD,SG,LWDHP and EZP, YGP and LZP)

EXPERIMENTAL

Syndrome differentiation treatment group of participants will be given medication by syndrome differentiating from qualified TCM Practitioners. TCM Practitioners will base on the syndrome of the participants to evaluate and modify the prescription after each assessment. 1. Liver and Kidney Yin Deficiency syndrome use Gan Mai Bai He Di Hung Tang(GMBHDHT); 2. Non Interaction Between Heart and Kidney syndrome use Tian Wang Bu Xin Dan(TWBXD); 3. Liver Stagnation and Qi Stagnation syndrome use Shugan Granules(SG); 4. Kidney Yin Deficiency syndrome use Liu Wei Di Huang Pill and Er Zhi Pill(LWDHP and EZP) ; 5. Spleen and Kidney Yang Deficiency syndrome use You Gui pill and Li Zhong pill addition and subtraction(YGP and LZP). Each dose will be prepackaged in two identical foil sachets. Participants will be instructed to drink one sachet of granules dissolved in 200 mL of warm water twice daily.

Drug: Intervention Group

Fixed formula treatment

EXPERIMENTAL

Fixed formula treatment Group will be given the standard formula Er-Xian decoction consisting of six herbs. The dosages of each herb were standardized according to the latest Chinese Medicine Recipe Dictionary (1997). The standard formula Er-Xian decoction are in the form of water-soluble granules. Each dose contains 11.8g and prepackaged in two identical foil sachets. Participants were instructed to drink one sachet of granules dissolved in 200 mL of warm water twice daily.

Drug: Control Group

Interventions

Intervention Group DRUG

Gan Mai Bai He Di Hung Tang, Tian Wang Bu Xin Dan,Shugan Granules,Liu Wei Di Huang Pill and Er Zhi Pill , You Gui pill and Li Zhong pill addition and subtraction

Also known as: Chinese herbal medicine

Syndrome differentiation treatment(GMBHDHT, TWBXD,SG,LWDHP and EZP, YGP and LZP)

Control Group DRUG

Er-Xian decoction

Also known as: Chinese herbal medicine

Fixed formula treatment

Eligibility Criteria

• Age: 45 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Chinese women aged 45-55 years
• Menstruation abnormalities (menstrual irregularity in past 12 months; or menstrual period off at least twice in past 12 months; or amenorrhea of 2 to 12 months)
• Suffering any of the following perimenopausal symptoms: vasomotor symptoms (hot flushes, sweats), psychological symptoms (insomnia, migraine, irritability), or genitourinary symptoms (vaginal dryness, dyspareunia)
• Did not use hormonal therapy at least 3 months before entry into the study
• Willing to give a written informed consent form to participate in the clinical study

You may not qualify if:

• Bilateral ovarian resection or pelvic radiotherapy for ovarian cysts and uterine fibroids with a diameter greater than 4 cm
• Unexplained irregular vaginal bleeding
• Suffer from diabetic neuropathy or malignant tumor
• Have used sex hormones in the past 3 months, such as estrogen, progesterone, soy isoflavones etc.
• Patients who have participated in or are participating in other clinical trials in the past 3 months
• Serious primary diseases such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system
• Take sedatives or anti-anxiety drugs regularly
• Smoking or alcohol habits
• Patients with mental illness
• Cannot cooperate with the treatment

Sponsors & Collaborators

• Hong Kong Baptist University: lead

Study Sites (1)

HKFTU Workers' Medical Clinics - Hong Kong Baptist University Chinese Medicine Clinic cum Training and Research Centre (North District)

Hong Kong, Hong Kong

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: March 4, 2022
• Study Start: March 14, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)