Health Condition 1: N970- Female infertility associated withanovulation
Conditions
Interventions
Intervention1: probiotic capsule: Women with PCOS will receive the standard therapy along with
Probiotic capsule [L. acidophilus, L. rhamnosus, L. reuteri (each 2 billion
CFU)
L. plantarum, L. casei, L. fermentum, Bifidobacterium bifidum
(each 1 billion CFU) and fructo-oligosaccharides (100 mg)] once daily
for 3 months.
Control Intervention1: placebo capsule: Women with PCO
Sponsors
JIPMER Intramural Research Fund
Eligibility
Inclusion criteria
Inclusion criteria: Women with PCOS visiting Obstetrics and Gynecology OPD, aged 18 to 35 years, diagnosed as per Rotterdam"s criteria with the presence of any two of the following: 1) Oligomenorrhea/ dysmenorrhea 2) Clinical &/or biochemical Hyperandrogenism, 3) Polycystic ovarian morphology on ultrasound.
Exclusion criteria
Exclusion criteria: Women with endocrine disorders, morbid obesity, known CVD, any hormonal therapy, drugs affecting autonomic nervous system, pregnancy, women actively engaged in any physical activity such as yoga, exercise and known GI disorders will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in heart rate , blood pressure, Autonomic function test and Baroreceptor reflex sensitivity, Body composition parametersTimepoint: The parameters are recorded at the baseline and at the end of 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in Metabolic profile (Serum glucose, Serum Insulin, HOMA IR, Lipid profile), Inflammatory marker (TNF-a), Serum testosterone, Body composition parameters (Body fat mass (kg & %), Lean body mass (kg & %), BFMI, FFMI, FTLM ratio)Timepoint: Baseline & 12 Weeks | — |
Countries
India
Contacts
Public ContactDr D Devi
Jawaharlal Institute of Postgraduate Medical Education & Research
Outcome results
None listed