Health Condition 1: E282- Polycystic ovarian syndrome
Conditions
Interventions
Intervention1: Celehealth Myoshape (Protein, Myo inositol, D-chiro inositol and micronutrient-based supplement): One heaped scoop of the test product in 200 ml lukewarm water, consumed within 20 minut
Sponsors
Dr. Reddys Laboratories Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1) Non-pregnant /non-lactating females. 2) Overweight and Obese participants with BMI range from 23 kg/m2 to 35 kg/m2 3) Participants with HbAlC below 6.5 % (normal and prediabetic participants) 4) Participants with PCOS and with presence of any two of the following parameters (Rotterdam criteria): o Clinical hirsutism (Ferriman-Gallwey score of greater than or equal to 4 to greater than or equal to 8 or as per clinical judgement) or biochemical hyperandrogenism (only total testosterone- greater than 50 ng/dL) o evidence of oligo-anovulation (oligo amenorrhea (cycles more than 35 days apart or less than 8 menses a year) o polycystic appearing-ovarian morphology on ultrasound, with exclusion of other relevant disorders. (Greater than or equal to 20 follicles per ovary in either ovary or greater than or equal to 10 cm3 ovarian volume) 5) Participants with a Menstrual Cycle length of 25 - 50 day. 6) Participants who have completed a one-month washout period, in case of any hormone treatments within the last 24 weeks.
Exclusion criteria
Exclusion criteria: 1) Participants with hypothyroidism or hyperthyroidism as confirmed by lab test (T3, T4 and TSH) 2) Participants who have received any drugs to support conception. 3) Participants with presence of other conditions causing ovulatory dysfunction, such as hyperprolactinemia or hyper/hypothyroidism, or androgen excess, such as adrenal hyperplasia or Cushings syndrome / with a suspected adrenal or ovarian tumor secreting androgen. 4) Participants who have undergone major surgery of any organ system in the opinion of PI and defined in terms of factors like significant patient comorbidity, key surgical parameters (long operative duration, organ ischemia, blood loss more than 1000mL, high vasopressor use), post operative metabolic stress response, 30-day morbidity, more than 2% and the need for intermediate or intensive care in the past 1 month. 5) Participants on confounding medications which affect ovarian function including metformin (Participants who were using metformin and who have completed a one-month washout period, can be included in the study) or Using insulin sensitizing drugs or Any pharmacotherapy capable of interfering with glucose metabolism or any drug to support conception. 6) Participants undergoing treatment with products containing inositol in the previous 3 months. 7) Hospitalization for an infectious condition within 4 weeks prior to study entry. 8) Participants who are allergic to the ingredients (Myo-inositol, INS 460 (i), Alpha-lipoic acid, Minerals, Inositol (D-chiro), Vitamins) of the interventional product. 9) Participants actively trying for conception via ART Therapy. 10) Any other condition in the opinion of the Principal Investigator which may interfere with study results and affect the participants safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Assessment of change in dietary intake using 3-day dietary recall 2. Assessment of Androgen-associated outcomes 3. Assessment of Glucose metabolism outcomes and insulin resistanceTimepoint: 1. Visit 01P (Baseline) and Visit 02P (Within 1 week after 3-months of IP Consumption) 2. Screening Visit (only for TT), Visit 01P (Baseline) and Visit 02P (Within 1 week after 3-months of IP Consumption) OR Visit 03P (2-4th day of menses that occur within 50 days after 3-months of IP Consumption) 3. Screening Visit (only for HbA1c), Visit 01P (Baseline) and Visit 02P (Within 1 week after 3-months of IP Consumption) | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of Androgen-associated outcomesTimepoint: Visit 01P (Baseline) & Visit 02P (Within 1 week after 3-months of IP Consumption) OR Visit 03P (2-4th day of menses that occur within 50 days after 3-months of IP Consumption);Assessment of characteristics associated with PCOSTimepoint: Visit 01P (Baseline) & Visit 02P (Within 1 week after 3-months of IP Consumption) AND Visit 03P (2-4th day of menses that occur within 50 days after 3-months of IP Consumption);Assessment of Body OutcomesTimepoint: Visit 01P (Baseline) and Visit 02P (Within 1 week after 3-months of IP Consumption);Assessment of Lipid metabolism outcomesTimepoint: Visit 01P (Baseline) and Visit 02P (Within 1 week after 3-months of IP Consumption);Assessment of menstrual cycles associated parametersTimepoint: Visit 01P (Baseline) & Visit 02P (Within 1 week after 3-months of IP Consumption) AND Visit 03P (2-4th day of menses that occur within 50 days after 3-months of IP Consumption);Assessment of parameters related to Infertility (a) Size of Ovary by Ultrasound Scanning (b) Conception, if any. Timepoint: (a) Visit 01P (Baseline) & Visit 02P (Within 1 week after 3-months of IP Consumption) OR Visit 03P (2-4th day of menses that occur within 50 days after 3-months of IP Consumption) (b) Visit 01P (Baseline), Visit 02P (Within 1 week after 3-months of IP Consumption) AND Visit 03P (2-4th day of menses that occur within 50 days after 3-months of IP Consumption) | — |
Countries
India
Contacts
Public ContactDr Rachana Bhoite
Cliantha Research
Outcome results
None listed