NCT01805765

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2013

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 6, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

April 5, 2019

Status Verified

March 1, 2013

Enrollment Period

1.6 years

First QC Date

February 26, 2013

Last Update Submit

April 3, 2019

Conditions

Menopause

Keywords

menopausal syndromeclimacteric syndromeHot flashesSweat

Outcome Measures

Primary Outcomes (1)

  • Hot flushes

    Change in frequency of hot flushes from baseline to week 12.

    12 weeks

Secondary Outcomes (4)

  • Hot flushes

    4 weeks, 8 weeks

  • Hot flushes

    4 weeks, 8 weeks and 12 weeks

  • Mean differences of Kupperman index

    4 weeks, 8 weeks and 12 weeks

  • Mean difference of single clinical symptom in Kupperman index

    12 weeks

Other Outcomes (2)

  • Nerve-endocrine-immune (NEI） network profile

    12 weeks

  • Urine metabolomics

    4 weeks, 8 weeks and 12 weeks

Study Arms (2)

Qing'E pills

ACTIVE COMPARATOR

9 g pills,twice a day for 12 weeks

Drug: Qing'E pills

Placebo

PLACEBO COMPARATOR

9 g pills,twice a day for 12 weeks

Drug: Placebo

Interventions

Qing'E pillsDRUG

composed of eucommia, psoralen, walnuts and garlic

Qing'E pills
PlaceboDRUG

Containing 2% of Qing'E pills

Placebo

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women age between 40 to 60 Years, Suffering from irregular menstrual cycle or amenorrhea of 3-11 months.
  • Moderate to severe hot flashes (associated with sweating)≥5 times /24 hours.
  • Patients unused estrogen tablets or progesterone injection in 6 months.
  • Patients must discontinue other therapies in the treatment of menopausal syndrome for more than 3 months.
  • Get subjects informed consent process should comply with GCP requirements.

You may not qualify if:

  • Patients with hypertension, primary hypotension and chronic anemia (Hb ≤ 90 g / L).
  • Bilateral oophorectomy, endometrial lesions, uterine polyps, abnormal vaginal bleeding, severe breast hyperplasia, with family history of breast cancer.
  • Allergic constitution and known allergy to the drug.
  • Patients with diseases of the cardiovascular, cerebrovascular, liver, kidney and hematopoietic system, or mentally ill.
  • Patients with hyperthyroidism, coronary atheroma, diabetes, obesity (body mass index of more than 30 kg/m2), migraine, malignant tumors, thromboembolic disease, gastrointestinal diseases affect absorption or autoimmune diseases.
  • Alcoholics or smokers (past or smoking).
  • Patients are participating in other clinical trials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 201108, China

Location

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Qingshan Zheng, Doctor

    Shanghai Universitu of TCM

    STUDY CHAIR

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
SPONSOR

Study Record Dates

First Submitted

February 26, 2013

First Posted

March 6, 2013

Study Start

March 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

April 5, 2019

Record last verified: 2013-03

Locations

CN(1)