Health Condition 1: null- Polycystic Ovarian Syndrome PCOS
Conditions
Interventions
Intervention1: Plant extracts based natural oil blends: MJR(F), Yin(PC) and Endobal
Control Intervention1: Placebo: Blend of Oil Soyabean, Sunflower, Mustard
Sponsors
Gods Own Store
Eligibility
Inclusion criteria
Inclusion criteria: 1. Married Female patients of age group 18-40 years diagnosed with polycystic ovarian syndrome/disease (PCOS or PCOD) and suffering from primary infertility, irregular/scanty menses due to anovulatory cycles and increased LH levels in blood will be included in the study. 2. LH: FSH ratio > 3 confirmed by hematological examinations, will be enrolled in the study. 3. Subjects with clinical or biochemical evidence of Hyperandrogenism will be included. 4. Subjects must have a negative pregnancy test. Pregnant patients and lactating mothers will be excluded from the study. 5. Participants should be willing to sign a written consent for participation in the study and undergo a baseline interview. 6. Participants must be willing to commit to medication dosing and assessment visits for evaluation. 7. Participants must be willing to refrain from taking any other medications for treatment of PCOD, irregular menses and infertility including HRT from the outset of the study until final evaluation (if patient force to take above said medicine, subject will be dropped from the study). 8. Participants must agree that during the study they will refrain from taking any new herbal supplement and prescription or nonprescription medications without prior approval of the research team. 9. Participants must agree to take healthy diet and life style.
Exclusion criteria
Exclusion criteria: 1. Unmarried subjects, 2. subjects who are pregnant or lactating mothers. 3. Patients currently on HRT or having taken any herbal medications in the last 30 days will be excluded from the study. 4. Patients diagnosed with cervical tumor, polyp or cervical cancer 5. Patient diagnosed with uterine fibroid, congenital anomalies in female genital tract, tubercular endometritis, congenital adrenal hyperplasia. 6. Patients that are HIV/VDRL/HbsAg positive. 7. Participants with evidence or history of significant systemic, immunological, gynaecological disorder. (People with hypothyroidism who are on adequate and stable thyroid replacement will not be excluded). 8. Any participant who is not able to give adequate informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Number of patients achieving a composite score of 0 (indicative of the absence of symptoms and signs associated with PCOS) at the end of day 30 and day 60 2. Increase in total number of patients with a lower score, indicative of reduction in severity of the disease, for a given subjective parameter at day 30 and day 60. 3. reduction in number of cysts by pelvic USG examination. Timepoint: 1. Number of patients achieving a composite score of 0 (indicative of the absence of symptoms and signs associated with PCOS) at the end of day 30 and day 60 2. Increase in total number of patients with a lower score, indicative of reduction in severity of the disease, for a given subjective parameter at day 30 and day 60. 3. reduction in number of cysts by pelvic USG examination. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety evaluation will be done by recording adverse events and severe adverse events during each follow up visit. 2. normalized LH levels and LH/FSH ratioTimepoint: At the end of Day 60 | — |
Countries
India
Contacts
Public ContactDr Anit Singh MD
Clinical Research Network India
Outcome results
None listed