Acupuncture in the Regulation of Dai Meridian for Polycystic Ovarian Syndrome Patients With Abdominal Obesity
Primary Purpose
Polycystic Ovarian Syndrome, Obesity, Abdominal
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
electroacupuncture
lifestyle modification
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovarian Syndrome focused on measuring electroacupuncture, lifestyle modification, diet, exercise, Dai Meridian
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of Polycystic Ovarian Syndrome.
- Clinical diagnosis of abdominal obesity.
- Agree to participate in clinical trials.
Exclusion Criteria:
- Endocrine or neoplastic causes of amenorrhoea, anovulation and hyperandrogenemia, including central nervous system abnormalities, premature ovarian failure, thyroid disease, Cushing's syndrome,androgen secreting tumors, congenital adrenal hyperplasia, and hyperprolactinaemia.
- Patients suffering from other serious diseases(cardiocerebrovascular diseases, damage to the function of liver and kidney, and mental illness).
- Patients taking hormonal and metabolic drugs within 12 weeks of study entry affecting the judgment of results.
- Pregnant or breast feeding.
Sites / Locations
- Department of Acupuncture and Moxibustion, Dongfang Hospital, Beijing University of Chinese Medicine
- Dongfang Hospital Affiliated to Beijing University of Chinese
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
acupuncture & lifestyle modification
lifestyle modification
Arm Description
Electro-acupuncture is given three times a week with diet restriction to 1400 calories a day and moderate aerobic exercise 3h a week for 12 weeks.
diet restriction to 1400 calories a day and moderate aerobic exercise 3h a week for 12 weeks
Outcomes
Primary Outcome Measures
rate of recovered ovulation
the proportion of patients who have ovulation after treatment
Secondary Outcome Measures
evidence of clinically definite hyperandrogenism confirmed by mF-G score
evidence of clinically definite hyperandrogenism confirmed by the Global Acne Grading System
frequency of menstruation
quantity of menstruation
pictorial blood loss assessment chart
Serum total testosterone (T)
FSH
follicle stimulating hormone (FSH)
LH
luteinizing hormone (LH)
ovarian volume measured by ultrasound
follicle number pre ovary measured by ultrasound
ovarian stromal blood flow measured by ultrasound
body weight in kilograms
waist circumference in centimeter
BMI in kg/m^2
waist-to-height ratio
waist-to-height ratio=waist circumference in centimeter/height in centimeter
Fasting serum PAI-1 level
International physical activity scale (IPAQ) short version
Full Information
NCT ID
NCT02785965
First Posted
May 23, 2016
Last Updated
September 11, 2017
Sponsor
Dongfang Hospital Beijing University of Chinese Medicine
Collaborators
Beijing University of Chinese Medicine, Beijing Municipal Science & Technology Commission
1. Study Identification
Unique Protocol Identification Number
NCT02785965
Brief Title
Acupuncture in the Regulation of Dai Meridian for Polycystic Ovarian Syndrome Patients With Abdominal Obesity
Official Title
Acupuncture in the Regulation of Dai Meridian for Polycystic Ovarian Syndrome Patients With Abdominal Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dongfang Hospital Beijing University of Chinese Medicine
Collaborators
Beijing University of Chinese Medicine, Beijing Municipal Science & Technology Commission
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether the use of electroacupuncture to dredge and regulate Dai Meridian combined with lifestyle modification are more effective than lifestyle modification only in the treatment of anovulation and hyperandrogenism due to polycystic ovary syndrome (PCOS) with abdominal obesity.Two thirds of participants will receive electroacupuncture and lifestyle modification in combination, while the other one third will receive lifestyle modification only.
Detailed Description
Obesity, especially abdominal obesity, is one of most common clinical features of polycystic ovary syndrome, a widely and seriously influenced complex disorder related to reproduction and metabolism. Excessive accumulation of adipose tissue in the abdominal organs often leads to insulin resistance, which will increase the harm of hyperandrogenism and exacerbate ovulation disorders and metabolic abnormalities.
Weight loss, likely beneficial for both reproductive and metabolic dysfunction in this setting , has been generally recommended as a first-line therapy for obese women with PCOS and can be accomplished via lifestyle modification and electroacupuncture. What's more, stimulating acupoints of Dai Meridian can regulate menstrual cycles and treat infertility according to the theory of traditional Chinese medicine. However, how much benefits patients will additionally get from the Combined therapy is not clear now.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovarian Syndrome, Obesity, Abdominal
Keywords
electroacupuncture, lifestyle modification, diet, exercise, Dai Meridian
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
acupuncture & lifestyle modification
Arm Type
Experimental
Arm Description
Electro-acupuncture is given three times a week with diet restriction to 1400 calories a day and moderate aerobic exercise 3h a week for 12 weeks.
Arm Title
lifestyle modification
Arm Type
Active Comparator
Arm Description
diet restriction to 1400 calories a day and moderate aerobic exercise 3h a week for 12 weeks
Intervention Type
Device
Intervention Name(s)
electroacupuncture
Intervention Description
Disposable, single-use, sterilized stainless-steel needles (Yunlong, Beijing, China; length 40/100 mm, diameter 0.30 mm) are inserted into waist, bilaterally. All of the six points are located in the Dai Meridian route corresponding to the ovaries. Four needles, 0.25mm in diameter and 25mm in length, are also placed in distal acupuncture points which are located in the feet and lower arms to enhance local points' effects. Acupuncture needles of 0.3mm in diameter and 100mm in length are inserted into GB26(Daimai) with a depth of 25-65mm by an angle of 15°, following the path of Dai Meridian (towards medial and downside). The other needles are inserted vertically into the acupoints with a depth of 10-30mm, depending on the thickness of muscles. Electro-acupuncture is applied to both sides of GB26 and ST25(Tianshu): cathode is connected to GB26; anode to ST25. Needles are stimulated electrically with low frequency (2 Hz) for 20 min.
Intervention Type
Behavioral
Intervention Name(s)
lifestyle modification
Intervention Description
The diet restricts patients to 1400 calories a day for 12 weeks.The exercise included 12 weeks of aerobic exercise in moderate level (60 to 70% of maximum heart rate), for 3 sessions a week, each session for 60 min. The exercises included: Warning up: 10 min, main phase (aerobic exercise): 40 min and cooling down: 10 min. Polar Pulse measuring device from China was used to control the intensity of the exercises.
Primary Outcome Measure Information:
Title
rate of recovered ovulation
Description
the proportion of patients who have ovulation after treatment
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
evidence of clinically definite hyperandrogenism confirmed by mF-G score
Time Frame
12 weeks
Title
evidence of clinically definite hyperandrogenism confirmed by the Global Acne Grading System
Time Frame
12 weeks
Title
frequency of menstruation
Time Frame
12 weeks
Title
quantity of menstruation
Description
pictorial blood loss assessment chart
Time Frame
12 weeks
Title
Serum total testosterone (T)
Time Frame
12 weeks
Title
FSH
Description
follicle stimulating hormone (FSH)
Time Frame
12 weeks
Title
LH
Description
luteinizing hormone (LH)
Time Frame
12 weeks
Title
ovarian volume measured by ultrasound
Time Frame
12 weeks
Title
follicle number pre ovary measured by ultrasound
Time Frame
12 weeks
Title
ovarian stromal blood flow measured by ultrasound
Time Frame
12 weeks
Title
body weight in kilograms
Time Frame
4, 8 and 12 weeks
Title
waist circumference in centimeter
Time Frame
4, 8 and 12 weeks
Title
BMI in kg/m^2
Time Frame
4, 8 and 12 weeks
Title
waist-to-height ratio
Description
waist-to-height ratio=waist circumference in centimeter/height in centimeter
Time Frame
4, 8 and 12 weeks
Title
Fasting serum PAI-1 level
Time Frame
12 weeks
Title
International physical activity scale (IPAQ) short version
Time Frame
4, 8 and 12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of Polycystic Ovarian Syndrome.
Clinical diagnosis of abdominal obesity.
Agree to participate in clinical trials.
Exclusion Criteria:
Endocrine or neoplastic causes of amenorrhoea, anovulation and hyperandrogenemia, including central nervous system abnormalities, premature ovarian failure, thyroid disease, Cushing's syndrome,androgen secreting tumors, congenital adrenal hyperplasia, and hyperprolactinaemia.
Patients suffering from other serious diseases(cardiocerebrovascular diseases, damage to the function of liver and kidney, and mental illness).
Patients taking hormonal and metabolic drugs within 12 weeks of study entry affecting the judgment of results.
Pregnant or breast feeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui HU, Doctor
Organizational Affiliation
Dongfang Hospital Beijing University of Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Acupuncture and Moxibustion, Dongfang Hospital, Beijing University of Chinese Medicine
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100078
Country
China
Facility Name
Dongfang Hospital Affiliated to Beijing University of Chinese
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100078
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25878993
Citation
Abazar E, Taghian F, Mardanian F, Forozandeh D. Effects of aerobic exercise on plasma lipoproteins in overweight and obese women with polycystic ovary syndrome. Adv Biomed Res. 2015 Mar 25;4:68. doi: 10.4103/2277-9175.153892. eCollection 2015.
Results Reference
background
PubMed Identifier
10955058
Citation
Case problem: dietary recommendations to combat obesity, insulin resistance, and other concerns related to polycystic ovary syndrome. J Am Diet Assoc. 2000 Aug;100(8):955-7; discussion 957-60. doi: 10.1016/S0002-8223(00)00275-3. No abstract available.
Results Reference
background
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Acupuncture in the Regulation of Dai Meridian for Polycystic Ovarian Syndrome Patients With Abdominal Obesity
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