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Efficacy and Safety of Traditional Chinese Medicine Intervention for Women With Menopausal Syndrome

Primary Purpose

Menopausal Syndrome

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
TCM intervention
Western intervention
Sponsored by
Guangzhou University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menopausal Syndrome focused on measuring menopausal syndrome, TCM intervention

Eligibility Criteria

41 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Foshan Hospital of Traditional Chinese Medicine
  • Guangzhou University of Traditional Chinese Medicine
  • Liwan Hospital of Traditional Chinese Medicine
  • Affiliated Hospital of Hubei College of Traditional Chinese Medicine
  • Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
  • Affiliated Hospital of Wenzhou Medical College
  • Longhua Hospital of Shanghai University of Traditional Chinese Medicine
  • Baokang Hospital of Tianjin University of Traditional Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TCM intervention

Western intervention

Arm Description

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

Tibolone and supportive psychotherapy and Particle placebo of compound Chinese herbs

Outcomes

Primary Outcome Measures

Kupperman index

Secondary Outcome Measures

blood serum estradiol

Full Information

First Posted
July 2, 2009
Last Updated
June 15, 2012
Sponsor
Guangzhou University of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00933725
Brief Title
Efficacy and Safety of Traditional Chinese Medicine Intervention for Women With Menopausal Syndrome
Official Title
Efficacy and Safety of Combined Treatment of Herbs and TCM Emotion Treatment for Women With Menopausal Syndrome: A Multiple-centered Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangzhou University of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Menopausal syndrome is a high incident disease which is associated with great influence in women's health and quality of life. It involves physical discomforts and emotional symptoms. Traditional Chinese medicine (TCM) theory emphasizes treating physical and emotional symptoms simultaneously viewing one person as an entirety. Herbs prescription and TCM emotion treatment is effective and safe to treat women with menopausal syndrome in clinical practice.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menopausal Syndrome
Keywords
menopausal syndrome, TCM intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
194 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TCM intervention
Arm Type
Experimental
Arm Description
Particle of compound Chinese herbs and TCM emotion treatment and tablet placebo of Tibolone
Arm Title
Western intervention
Arm Type
Active Comparator
Arm Description
Tibolone and supportive psychotherapy and Particle placebo of compound Chinese herbs
Intervention Type
Other
Intervention Name(s)
TCM intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Western intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Kupperman index
Time Frame
2 months
Secondary Outcome Measure Information:
Title
blood serum estradiol
Time Frame
2 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
41 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoyun Wang, Bachelor
Organizational Affiliation
Guangzhou University of Traditional Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foshan Hospital of Traditional Chinese Medicine
City
Foshan
State/Province
Guangdong
ZIP/Postal Code
528000
Country
China
Facility Name
Guangzhou University of Traditional Chinese Medicine
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Name
Liwan Hospital of Traditional Chinese Medicine
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510360
Country
China
Facility Name
Affiliated Hospital of Hubei College of Traditional Chinese Medicine
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430061
Country
China
Facility Name
Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610075
Country
China
Facility Name
Affiliated Hospital of Wenzhou Medical College
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Facility Name
Longhua Hospital of Shanghai University of Traditional Chinese Medicine
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Baokang Hospital of Tianjin University of Traditional Chinese Medicine
City
Tianjin
ZIP/Postal Code
300170
Country
China

12. IPD Sharing Statement

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Efficacy and Safety of Traditional Chinese Medicine Intervention for Women With Menopausal Syndrome

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