Health Condition 1: E282- Polycystic ovarian syndrome
Conditions
Interventions
Intervention1: Folliculinum: Oral Route of Administration.
pill form
30 pill size
centesimal scale starting from 30 potency to 10M.
first dose after case taking.
repetition based on follow ups every 4
Sponsors
Bakson Homoeopathic Medical College and hospital
Eligibility
Inclusion criteria
Inclusion criteria: Females aged 18 40 years PCOS diagnosed by Rotterdam 2023 criteria At least two of the following oligo/amenorrhea Clinical or biochemical hyperandrogenism Polycystic ovarian morphology Cycle length more than 35 days Or less than 21 days Or amenorrhea
Exclusion criteria
Exclusion criteria: Current pregnancy or lactation Ovarian malignancy Uterine malignancy Active pelvic inflammatory disease Severe hepatic impairment Severe renal impairment eGFR less than or equal to 30 mL per minute AST or ALT more than three times normal Participation in another interventional study within 30 days Uncontrolled diabetes with HbA1c more than 8.5 percent Well controlled type 2 diabetes on diet is allowed Well controlled type 2 diabetes after 4 week washout from metformin is allowed Major psychiatric illness requiring hospitalization in past 6 months Stable depression or anxiety on unchanged medication for at least 3 months is allowed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The objective is to measure the percentage of participants who develop a regular menstrual pattern after six months of Folliculinum A regular cycle is defined as 21 to 35 days with bleeding lasting no longer than seven days Another objective is to assess changes in cycle related quality of life as reported by participants This will be measured using a validated PCOS specific questionnaireTimepoint: Total 16 months Enrollment period 6 months Follow up 6 months Data Analysis 2 months Report writing 2 months PCOS Questionnaire at baseline and end | — |
Secondary
| Measure | Time frame |
|---|---|
| To track and compare pre and post treatment ultrasound findings The focus is on ovarian structure and on average ovarian volume and also on antral follicle count Another objective is to monitor adverse events and to record adverse events and also to interpret adverse events And the adverse events related to FolliculinumTimepoint: Total 16 months Enrollment period 6 months Follow up 6 months Data Analysis 2 months Report writing 2 months Ultrasound at baseline and end | — |
Countries
India
Contacts
Public ContactDr Akshay Mathur
Bakson Homoeopathic Medical College and Hospital
Outcome results
None listed