MedPath

Ayurvedic management of polycystic ovarian syndrome in adolescents and young adults

Phase 3
Conditions
Health Condition 1: N830- Follicular cyst of ovary
Registration Number
CTRI/2023/03/050440
Lead Sponsor
Archana S
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1. Adolescent girls of age group 13-19 years(age based on evidence from researches, those who were within gynecological age of 8 years or less than 8 years post menarche were also included.)

2.Young Adults in the age group 19-25years.

3. Overweight and Obese girls with BMI >23(WHO Asian BMI classification)

4. Adolescent after 2 years of menarche.

5. Adolescent who are at risk of PCOS,newly Diagnosed and already diagnosed (with in 3 years) cases of PCOS will be included in the study.

6.Any one or two following feature of Artavadusti

A. Artavakshaya- Oligomenorrhoea or Amenorrhoea( > 1yr postmenarche, 90 days for any cycle)

B. Atipravruti & Vikruti -Menstrual irregularities ( <12 or >45 days in >1 to <3yrs

and <21 to > 35 days in >3 yrs postmenarche.)

7. Hyperandrogenism(clinical/Biochemical)

a. Clinical- Hirsutism,Acne,Male pattern

alopecia(Any one)

b. Biochemical- Increase S. Total

Testosterone

HIR was defined by a modified Ferriman -Gallway(mFG) SCORE OF >6.

Hyperandrogenemia was defined by an androgen value exceeding the 95th percentile of 98 race-matched eumenorrheic control women from the same population,as previous reported testosteron (T) >88ng/dL.

On Physical examination ,in addition to measuring height, weight and mFG, the waist circumference measured at the narrowest portion of trh torso, approxmately midway between the lower costal margin and iliac crest.

the Hip circumference was measured over thw widest portion of the gluteal and greater trochanteric region.

Exclusion Criteria

1. Pelvic/systematic disease causing the oligomenorrhea and Anovulation.

2. Organic lesion of reproductive tract like T.B, Carcinoma and congenital deformities.

Patient suffering from the ant of the following clinical condition will be excluded

a. Congenital Adrenal Hyperplasia

b. Androgen secreting Neoplasm

c. Cardiac Disease

d. Cushing Syndrome

4. Patient suffering from uncontrolled Diabetic (FBS >150mg)or Hypertension ( >130/90 mm/Hg)

5.Unwilling patients

6.Pregnancy

7.Below age of 13 yrs and above the age of 25yrs.

8.Married Patient.

9.Current and previous(with in last 3 months) use of OC pills,Glucocorticoids,Anti-androgens,Anti-obesity and Antidiabetic or other hormonal medication.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1.Change in features of oligomenorrhoea/Anovulation <br/ ><br> <br/ ><br>2. Reduction of weight by 5%Timepoint: Base line and at 3 months
Secondary Outcome Measures
NameTimeMethod
1. Improvement in Metabolic and hormonal parameters. <br/ ><br>2. Reduction in the Waist/Hip Ratio, <br/ ><br>3. Change in the clinical findings of Hyperandrogenism like Acne (Global acne grading system),Hirsutism (Modified Ferriman gallwey score) <br/ ><br>4. Improvement in Quality of life(SF-36 Questionnaire)Timepoint: Base line and at 3 months
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