RCT on the Treatment of Menopausal Syndrome With Chinese Medicine

NCT06074809 | Unknown Phase 2 DMC

• 1 other identifier: Menopause study
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

This is a double-blinded, randomized, placebo-controlled clinical trial. Subjects will be randomly assigned to the treatment group (Modified Guizhi Fuling granules) or placebo group (Placebo granules) for 8 weeks. Outcomes will be measured at week 8 and week 12.

Conditions

Menopause

Keywords

Traditional Chinese medicine

Outcome Measures

Primary Outcomes (1)

• Greene Climacteric Scale (Chinese version)

  Greene Climacteric Scale (GCS) is one of the most common scales used to assess menopause. It includes four aspects of symptoms: vasomotor, somatic, psychological, and sexual response. This scale consists of 21 symptoms that can be assessed by patients themselves. The scoring from 0 to 3 in each item, indicates 'Not at all', 'A little bit', 'Much', and 'Very much' respectively.

  Week 8

Secondary Outcomes (9)

• Short-Form Health Survey, SF-12v2 (Chinese version)

  Week 8

• Short-Form Health Survey, SF-12v2 (Chinese version)

  Week 12

• Temperature change of face, limbs and abdomen

  Week 8

• Temperature change of face, limbs and abdomen

  Week 12

• Level change of sex hormones

  Week 8

Study Arms (2)

Traditional Chinese medicine treatment group

EXPERIMENTAL

Chinese medicine will be administered to patients in this group.

Drug: Modified Guizhi Fuling granules

Placebo group

PLACEBO COMPARATOR

Placebo will be administered to patients in this group.

Other: Placebo

Interventions

Modified Guizhi Fuling granules DRUG

Modified Guizhi Fuling granules will be orally administered to patients in the TCM treatment group twice a day throughout the treatment period, which lasts for 8 weeks.

Also known as: Chinese medicine

Traditional Chinese medicine treatment group

Placebo OTHER

Placebo will be orally administered to patients in the placebo group twice a day throughout the treatment period, which lasts for 8 weeks.

Placebo group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female subjects with age between 40 and 60 years old;
• For those who have symptoms of primary menopause (irregular menstruation lasting for more than 6 months, or absence of menstrual periods for more than 3 months)
• The score of the physical symptoms in Greene Climacteric Symptom Score (GCS) is 6 or above (average level);
• Have moderate level (affecting certain level of daily activity) or severe (cannot carry out daily activity) hot flashes, defined as transient sensations of heat, sweating, flushing, anxiety and chills lasting for 1-5 minutes;
• Diagnosed Deficiency of Kidney essence and static blood in Lower Jiao by Chinese medicine practitioner
• Agreed to receive Chinese medication or placebo for 2 months upon randomization.

You may not qualify if:

• The menopausal syndrome caused by surgical operations or medications (such as chemotherapy, gonadotropin-releasing hormone agonists, etc.).
• Have received estrogen treatment in the past 2 months;
• Have received any medication for treating menopause in the past month, including herbs, non-prescribed drugs, supplements, or change of diet to consume more legumes;
• Known serious emotional, mental or psychological disorders that may affect the study;
• During pregnancy, pre-pregnancy period, or lactation period;
• Known history of allergy to any traditional Chinese medicine;
• Have received anticoagulant or antiplatelet drugs in the past month;
• Known history of some certain serious medical disease, such as cardiovascular disease, liver or renal dysfunction, diabetes, cerebrovascular disease, blood disorders, with unstable conditions;
• Chinese medicine pattern combined with damp phlegm or damp heat, or only deficiency of Yin blood or absence of static blood pattern.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

School of Chinese Medicine

Shatin, Hong Kong

Location

Study Officials

• Hongwei Zhang, PhD

  School of Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongwei Zhang, PhD

CONTACT

39439845; zhanghw@cuhk.edu.hk

Cho Wing Lo

CONTACT

35053476; louislo@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: School of Chinese Medicine

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 10, 2023
• Study Start: November 1, 2023
• Primary Completion: October 31, 2025
• Study Completion: January 31, 2026
• Last Updated: October 10, 2023

Record last verified: 2023-10

Locations

HK (1)