NCT01805765

Qing'E Formula Therapy on Menopausal Symptoms

A Randomized, Multicenter, Double-Blind, Placebo-Controlled Clinical Trial on the Effects of Chinese Medicine Formula (Qing'E) on Menopausal Symptoms

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Shanghai University of Traditional Chinese Medicine · Academic / Other
• Sex: Female
• Age: 40 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate whether a Chinese medicine formula (Qing'E) is effective in alleviating menopausal symptoms and safety.

Detailed description

This is a double-blind placebo-controlled randomized clinical trial to evaluate whether a Chinese medicine formula (Qing'E, composed of eucommia, psoralen, walnuts and garlic) is effective in alleviating menopausal symptoms. 240 Chinese women with menopausal symptoms will be recruited and randomized into two groups. One is treatment group with 12 weeks of Qing'E pills (well-controlled), the other is controlled group with 12 weeks of placebo. The treatment outcome measures include: 1) the severity of menopausal symptoms: self-recording of daily frequency of vasomotor symptoms (hot flushes), the Kupperman index. 2) NEI network indices. 3) Urine metabolomics. All measures are conducted at baseline and endpoint except the self-recoding of vasomotor symptoms, Kupperman index and urine metabolomics. Tyhe investigators expect this research will provide an effective and safe therapy for menopausal symptoms.

Conditions

• Menopause

Interventions

Type	Name	Description
DRUG	Qing'E pills	composed of eucommia, psoralen, walnuts and garlic
DRUG	Placebo	Containing 2% of Qing'E pills

Timeline

• Start date: 2013-03-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2013-03-06
• Last updated: 2019-04-05

Locations

1 site across 1 country: China