PCOSNIL in Polycystic Ovarian Syndrome

Phase III, randomized, double blind, multi center, active control clinical trial to assess the safety and efficacy of Cap. PCOSNIL in management of PCOS patients.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/05/052746

Enrollment

Registered

2023-05-17

Start date

Unknown

Completion date

Unknown

Last updated

2023-05-29

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

Conditions

Health Condition 1: N970- Female infertility associated withanovulation

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age â?? 18-45years. 2. Gender â?? Female. 3. Diagnosis of PCOS with Rotterdam criteria. (Any 2 of the 3) a. Oligo/anovulation. b. Hyperandrogenism. i. Virilization. ii. Sr. testosterone > 70 ng/dl c. Polycystic ovaries on USG i. Follicles >12 (measuring 2-9mm) ii. Ovarian volume > 10 ml. 4. BMI > 25Kg/m2. 5. Ready to give written informed consent.

Exclusion criteria

Exclusion criteria: 1. Haemoglobin 2. Known thyroid disorder TSH > 5mIU/L 3. DM fasting sugar > 150 mg/dl or HbA1c > 7. 4. Patient of DM on medication other than metformin. 5. Renal dysfunction creatinine > 1.4mg/dl or patients on dialysis 6. Liver enzymes (ALT, AST) normal or above the ULN (Upper Limit of Normal range but less than 3 times) 7. Known cardiovascular disease (Hypertensive/IHD/any other deformity â?? on medication). ECG QTc 8. On medication for any other disease in last 3 months. 9. Pregnancy and lactation. 10. Known case of Cushingâ??s syndrome. 11. Known case of primary adrenal hyperplasia. 12. Known case or H/O of HIV, Hepatitis B and Hepatitis C. 13. Any known case of malignancy. 14. Subjects on medications that may affect glucose metabolism such as corticosteroids. 15. Practicing dietary modification/dietary restrictions. 16. Patients on Phenytoin. (Interfere with androgenic activity) 17. Patients not willing to provide written consent. 18. Patients with a history of serious drug allergies (such as anaphylactic shock) 19. Participants not willing to use any form of contraception during the trial period. 20. Any disorder or clinically significant finding that may potentially impact the outcome measures as per the discretion of the study investigator.

Design outcomes

Primary

Measure	Time frame
Change in Insulin resistance â?? HOMA -IR (Homeostasis model assessment of Insulin resistance)Timepoint: time points will be 1. Baseline. 2. on completion of 12 weeks. 3. On completion of 24 weeks.	—

Secondary

Measure	Time frame
Change in testosterone levelsTimepoint: At 12 Weeks and 24 Weeks;Change in TNF â?? alphaTimepoint: At 12 Week and 24 Week;Change in WHRTimepoint: Every 4 Weeks;Change of FSH.Timepoint: At 12 Week and 24 Week;OvulationTimepoint: Every 4 weeks;Regulation of menstruationTimepoint: every 4 weeks;Change in AMHTimepoint: At 12 week and 24 week;Change in BMITimepoint: Every 4 Weeks;Change in FINS.Timepoint: At 12 weeks and 24 Weeks;Change in FPGTimepoint: At 12 Week and 24 Week;Change in LHTimepoint: At 12 weeks and 24 Weeks;Change in ProlactinTimepoint: At 12 week and 24 week	—

Measure

Time frame

Change in testosterone levelsTimepoint: At 12 Weeks and 24 Weeks;Change in TNF â?? alphaTimepoint: At 12 Week and 24 Week;Change in WHRTimepoint: Every 4 Weeks;Change of FSH.Timepoint: At 12 Week and 24 Week;OvulationTimepoint: Every 4 weeks;Regulation of menstruationTimepoint: every 4 weeks;Change in AMHTimepoint: At 12 week and 24 week;Change in BMITimepoint: Every 4 Weeks;Change in FINS.Timepoint: At 12 weeks and 24 Weeks;Change in FPGTimepoint: At 12 Week and 24 Week;Change in LHTimepoint: At 12 weeks and 24 Weeks;Change in ProlactinTimepoint: At 12 week and 24 week

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Countries

India

Contacts

Public ContactDr Shantanu R Joshi

Department of Clinical Pharmacology Seth G S Medical College KEM Hospital Mumbai

drjoshisr@gmail.com9822295738

Outcome results