Skip to content

Randomized controlled trial of Guixian granules for the treatment of hot flashes in menopausal syndromes and study on the basis of pharmacodynamic substances

Randomized controlled trial of Guixian granules for the treatment of hot flashes in menopausal syndromes and study on the basis of pharmacodynamic substances

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085647
Enrollment
Unknown
Registered
2024-06-14
Start date
2024-07-01
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hot flashes in menopausal syndromes (MPS-HFs)

Interventions

Low-dose pellet group:0.5x Guixian granules (half the original dose) + placebo (soup)
Medium Dose Granules Group:Original Bei Guixian Granules + Placebo (Soup)
High-dose pellet group:2x Guixian granules (for 2x the original dose) + placebo (soup)
Control subjects:Guixian herbal Soup + Placebo (Granules)

Sponsors

The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
40 Years to 60 Years

Inclusion criteria

Inclusion criteria: ? Women between 40 and 60 years of age (both 40 and 60 years of age); ? Have menstrual disorders (=2 changes in the length of adjacent menstrual cycles >7 days in 10 months) and symptoms of hot flashes and sweating; ? KI score = 15 points; ? Those who signed the informed consent form.

Exclusion criteria

Exclusion criteria: ?Persons with confirmed pregnancy or those with reproductive needs; ? Those who have untreated irregular vaginal bleeding of unknown cause; ? Those who have combined serious primary diseases such as cardiovascular, cerebrovascular, hepatic, renal, endocrine and hematopoietic systems or psychiatric diseases; ? Those who have used sex hormone drugs or taken the same type of Chinese medicine or proprietary Chinese medicine in the last 1 month; ? Those who have conditions that affect the absorption of orally administered drugs (e.g. gastrectomy).

Design outcomes

Primary

MeasureTime frame
Domestic improvement of the Kupperman Index score;

Secondary

MeasureTime frame
Sex hormone level;Pittsburgh Sleep Quality Index Score (PSQI) ;Menopausal Quality of Survival Scale (MENQOL) ;Chinese Medicine Symptom Score;

Countries

China

Contacts

Public ContactZhou Ying

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

1029153966@qq.com+86 134 8025 1288

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026