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Auricular Acupressure (AA) For Insulin Resistance in Women With Polycystic Ovary Syndrome

H

Heilongjiang University of Chinese Medicine

Status

Unknown

Conditions

Insulin Resistance
Polycystic Ovary Syndrome

Treatments

Other: Sham auricular acupoints acupressure
Other: Auricular acupoints acupressure

Study type

Interventional

Funder types

Other

Identifiers

NCT03546595
AA for IR-PCOS

Details and patient eligibility

About

The present trial is a pilot study to investigate the effect of auricular acupressure on insulin resistance in women with PCOS.A total of 100 subjects will be enrolled into this study and will be randomized into two groups.

Auricular acupressure or sham auricular acupressure will be treated for three months. The primary outcome is the whole body insulin action assessed with HOMA-IR.

Enrollment

60 patients

Sex

Female

Ages

15 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Women aged between 15 and 40 years.
  • Diagnosis of PCOS according to the modified Rotterdam criteria.
  • 2 years after menarche.
  • Body mass index (BMI) equal to or greater than 23 kg/m2.
  • IR is defined by the homeostaticmodel assessment (HOMA-IR: (fasting insulin (μU/mL)×fasting glucose (mmol/L))/22.5). A value ≥2.14 will be considered to be indicative of IR.
  • With no desire of children within 3 months.

Exclusion criteria

  • Administration of other medications known to affect reproductive function or metabolism within the past three months, including oral contraceptives, Gonadotropin-releasing hormone (GnRH) agonists and antagonists, anti androgens, gonadotropins, anti-obesity drugs, Chinese herbal medicines, anti diabetic drugs such as metformin and thiazolidinediones, somatostatin, diazoxide, and calcium channel blockers.
  • Patients with other endocrine disorders including 21-hydroxylase deficiency, hyperprolactinemia, uncorrected thyroid disease, suspected Cushing's syndrome.
  • Patients with known severe organ dysfunction or mental illness.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 2 patient groups

Auricular acupoints acupressure
Experimental group
Treatment:
Other: Auricular acupoints acupressure
Sham auricular acupoints acupressure
Sham Comparator group
Treatment:
Other: Sham auricular acupoints acupressure

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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