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Acupuncture in the Regulation of Dai Meridian for Polycystic Ovarian Syndrome Patients With Abdominal Obesity

D

Dongfang Hospital Beijing University of Chinese Medicine

Status

Unknown

Conditions

Obesity, Abdominal
Polycystic Ovarian Syndrome

Treatments

Behavioral: lifestyle modification
Device: electroacupuncture

Study type

Interventional

Funder types

Other

Identifiers

NCT02785965
Z161100000516057

Details and patient eligibility

About

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.

Full 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.

Enrollment

84 estimated patients

Sex

Female

Ages

20 to 40 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

84 participants in 2 patient groups

acupuncture & lifestyle modification
Experimental group
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.
Treatment:
Behavioral: lifestyle modification
Device: electroacupuncture
lifestyle modification
Active Comparator group
Description:
diet restriction to 1400 calories a day and moderate aerobic exercise 3h a week for 12 weeks
Treatment:
Behavioral: lifestyle modification

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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