NCT00933725

Brief Summary

The purpose of this multiple-centered, randomized, controlled study is to investigate the efficacy and safety of a combination using herbs prescription and traditional Chinese medicine (TCM) emotion treatment in women with menopausal syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
194

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2009

Geographic Reach
1 country

8 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 7, 2009

Completed
25 days until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

June 18, 2012

Status Verified

May 1, 2010

Enrollment Period

1.7 years

First QC Date

July 2, 2009

Last Update Submit

June 15, 2012

Conditions

Menopausal Syndrome

Keywords

menopausal syndromeTCM intervention

Outcome Measures

Primary Outcomes (1)

  • Kupperman index

    2 months

Secondary Outcomes (1)

  • blood serum estradiol

    2 months

Study Arms (2)

TCM intervention

EXPERIMENTAL

Particle of compound Chinese herbs and TCM emotion treatment and tablet placebo of Tibolone

Other: TCM intervention

Western intervention

ACTIVE COMPARATOR

Tibolone and supportive psychotherapy and Particle placebo of compound Chinese herbs

Other: Western intervention

Interventions

TCM interventionOTHER

Drug: Particle of compound Chinese herbs(produced by San\_jiu Medical \& Pharmaceutical Limited Company, Guangzhou, Guangdong Province, China), mixing with boiled water, free of decoction, taken orally, twice a day, for two months. One tablet placebo of Tibolone (provided by San\_jiu Medical \& Pharmaceutical Limited Company, Guangzhou, Guangdong Province, China, once every two days, taken orally, for two months. Behavioral: TCM emotion treatment: made under the guide of TCM theory, administered by qualified TCM physician, for three times in two months.

TCM intervention
Western interventionOTHER

Drug: Tibolone, (produced by Oujianong corporation, Nanjing, China), 2.5mg, once every two days, taken orally, for two months; Particle placebo of compound Chinese herbs (produced by San\_jiu Medical \& Pharmaceutical Limited Company, Guangzhou, Guangdong Province, China), mixing with boiled water, free of decoction, taken orally, twice a day, for two months. Behavioral: supportive psychotherapy, administered by qualified physician, for three times in two months.

Western intervention

Eligibility Criteria

Age41 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 41-60;
  • Amenorrhea for at least 6 months;
  • Menstruation dysfunction or cessation because of age or bilateral ovariectomy;
  • Hot flushes and night sweats symptoms;
  • Vaginal secretion decreased with or without dyspareunia;
  • Kupperman Index (KI) score ≥ 15;
  • Self-rating Anxiety Scale or Self-rating Depression Scale standard score \>50,but \<72(standard score= scale score ×1.25);
  • FSH ≥ 20 IU/L;
  • Thickness of endometrium ≤0.5cm if Amenorrhea for at least 12 months;or ≤1.5cm if Amenorrhea for 6 months to 12 months;
  • Meet the diagnosis criteria of TCM syndrome of liver stagnation and kidney deficiency.

You may not qualify if:

  • With malignant tumor in reproductive system;
  • With benign tumor in reproductive system and need surgery;
  • Malignant tumor in mammary gland;
  • Irregular vaginal bleeding for unknown reasons;
  • Thickness of endometrium ≥1.5cm by ultrasound examination;
  • Have used Sex hormone medicine or joined other clinical trials 3 months before;
  • Allergy;
  • Severe diseases (eg., of the cardiovascular, liver, kidney) or uncontrolled endocrine diseases (eg., diabetes mellitus, hyperthyreosis )
  • Severe psychiatric disease diagnosed by psychiatric physician;
  • Refuse informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Foshan Hospital of Traditional Chinese Medicine

Foshan, Guangdong, 528000, China

Location

Guangzhou University of Traditional Chinese Medicine

Guangzhou, Guangdong, 510120, China

Location

Liwan Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, 510360, China

Location

Affiliated Hospital of Hubei College of Traditional Chinese Medicine

Wuhan, Hubei, 430061, China

Location

Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, 610075, China

Location

Affiliated Hospital of Wenzhou Medical College

Wenzhou, Zhejiang, 325000, China

Location

Longhua Hospital of Shanghai University of Traditional Chinese Medicine

Shanghai, 200032, China

Location

Baokang Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, 300170, China

Location

Study Officials

  • Xiaoyun Wang, Bachelor

    Guangzhou University of Traditional Chinese Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2009

First Posted

July 7, 2009

Study Start

August 1, 2009

Primary Completion

May 1, 2011

Study Completion

June 1, 2011

Last Updated

June 18, 2012

Record last verified: 2010-05

Locations

CN(8)