The effect of therapeutic models of Traditional Persian Medicine and Electro-Acupuncture on Polycystic Ovarian Syndrome

Phase 2

• Conditions: Polycystic Ovary Syndrome.; Polycystic ovarian syndrome

• Registration Number: IRCT2015040921671N1
• Lead Sponsor: Vice chancellor for research, Mashhad University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

The main inclusion criteria of the study: Women with polycystic ovary syndrome whose disease is diagnosed based on a series of clinical symptoms and laboratory; Aged between 15 and 40 years; And their Body Mass Index higher than 25.
The main Exclusion criteria of the study: 1: The desire to become pregnant during treatment; 2: Body Mass Index equal to or less than 25; 3: Menopause;
4: Uncontrolled blood pressure; 5: Pregnancy; 6: Smoking; 7: Alcohol consumption; 8: Patients with thyroid disorders: Thyroid-Stimulating Hormone higher or lower than normal; 9: Hyperprolactinemia (Prolactin more than 50); 10: Oral contraceptives, anti-diabetic, anticoagulants, estrogen and antiandrogen drug consumers in the three months prior to the study; 11: Mass in ultrasonography report; 12: The sudden appearance of symptoms such as hirsutism within a short time (suspect to androgen-producing tumors); 13: The higher the Testosterone concentration of 150 Ng per deciliter (probability of androgen producing tumors); 14: Fasting Insulin more than 80 micro units per milliliter (suspect to severe Insulin resistance syndrome); 15: Bleeding disorders; 16: Patients with psychological or biological sexual identity disorder; 17: Patients with severe psychiatric problems leading to hallucinations and delusions and psychosis

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Menstrual period. Timepoint: Three months before the start of treatment to the end of intervention (three months after the start) each month. Method of measurement: Calculated according to the patient statements.;Body Mass Index. Timepoint: Once a week, beginning and end of treatment (three months after the start). Method of measurement: By (Body Composition Analyzer System) model Gaia 359.;Fasting insulin. Timepoint: Before and three months after intervention. Method of measurement: Fasting serum insulin Concentration in µU/ml.;LH to FSH ratio. Timepoint: Before and three months after intervention. Method of measurement: Serum concentration in MIU/ML.;Polycystic ovary view on ultrasound. Timepoint: Before and three months after intervention. Method of measurement: The increase in the size of the stroma (more than 0.7 to 7.5 mm) or not (on average) more than 12 follicles with a diameter of 2 to 9 mm in both ovaries on ultrasound.

Secondary Outcome Measures

Name	Time	Method
Fast blood sugar. Timepoint: Before and three months after intervention. Method of measurement: Fasting serum sugar concentration in mg/dl.;Fast cholesterol. Timepoint: Before and three months after intervention. Method of measurement: Fasting serum cholesterol concentration in mg/dl.;Serum prolactin. Timepoint: Before and three months after intervention. Method of measurement: Serum prolactin concentration in ng/ml.;Liver enzymes: SGOT and SGPT. Timepoint: Before and three months after intervention. Method of measurement: Serum SGOT and SGPT concentration in U/l.;Waist-to-hip Ratio. Timepoint: Before and three months after intervention. Method of measurement: Manually using anatomical markers in cm.