To compare Inositol with oral contraceptive pills on menstrual regulation in young girls with PCOS.

To study the role of Myo-inositol-D-chiro-inositol Combination Versus Combined Oral Contraceptives on Clinico-hormonal and Metabolic Parameters in Young Asian-Indian Girls with Polycystic Ovary Syndrome

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/03/012643

Enrollment

Registered

2018-03-19

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Polycystic Ovary Syndrome (PCOS)

Interventions

Intervention1: Myo-inositol-D-chiro-inositol: Myo-inositol 550 mg + D-chiro-inositol 150 mg BD for 6 months Control Intervention1: Combined Oral Contraceptive: Combined Oral Contraceptive containing e

Eligibility

Inclusion criteria

Inclusion criteria: 1) Young girls in the age-group of 15-24 years (or atleast 2 years after the onset of menarche) with PCOS diagnosed by two out of the following criteria a) Hyperandrogenism - Clinical(hirsutism diagnosed by modified Ferriman -Gallwey score more than or equal to 8/36) or Biochemical (serum testosterone >0.5 ng/L) b) Persistent oligo/anovulation characterized by irregular menstrual cycles (19-90 days) or absent menstrual cycles ( for a period equivalent to previous 3 menstrual cycles) c) Polycystic ovaries on ultrasound diagnosed when ovarian volume more than 10 cu.cm. d) Insulin resistance 2) Patients who are willing to give consent for the study and willing for follow-up.

Exclusion criteria

Exclusion criteria: 1) Pregnancy. 2) A known case of diabetes mellitus. 3) Patients who are taking or had taken any hormonal treatment including contraceptives over the past 3 months. 4) Patients who are taking or who had used glucocorticoids, lipid-lowering drugs, glucose-lowering drugs or anti-obesity drugs within 3 months of the study.

Design outcomes

Primary

Measure	Time frame
1.Menstrual cycle length expressed as average of days between cycles. 2.Modified Ferriman- Gallwey score and Acne scoring Timepoint: 6 months and 3 months after stopping treatment.	—

Secondary

Measure	Time frame
1.Ovarian volumeâ??lxbxw (cc) 2.Change in Serum AMH, FSH, LH, Testosterone 3.Changes in blood sugar profile, lipid profile 4.Homeostatic Model Assessment (HOMA-IR) 5.Compliance 6.Body Weight Timepoint: 6 months and 3 months after stopping treatment	—

Countries

India

Contacts

Public ContactDr Krithika V S

All India Institute of Medical Sciences

garimakachhawa2012@gmail.com01126594941

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 14, 2026