Study on the Safety and Effectiveness of New Syrup and Capsule Treatment for Women with PCOS

Phase 3

Conditions: Health Condition 1: E35- Disorders of endocrine glands in diseases classified elsewhere

Registration Number: CTRI/2024/08/072073

Lead Sponsor: JAMMI PHARMACEUTICALS PVT LTD

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Young women of age between 18 to 40 yrs. diagnosed with PCOS

2.Sub-fertile females

3.Polycystic ovaries with exclusion of other aetiologies

4.Women with normal uterine cavity

5.Subjects with history of Impaired Glucose Tolerance or Insulin Resistance with PCOS

6.Normal physical activity confirmed with physical and clinical examination, and routine laboratory tests, including AST, ALT, haematology, routine urinalysis and measurement of oral temperature and vital signs.

Exclusion Criteria

1.Pregnant or lactating women.

2.Subjects with presence of infertility factors other than anovulation

3.Subjects with pelvic organic pathologies, presence of other pathologies such as non-classical congenital adrenal hyperplasia, Cushing’s syndrome and androgen secreting tumours

4.Subjects with thyroid dysfunction, hyperprolactinemia, androgen secreting neoplasm.

5.Women requiring, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs, or other hormonal drugs.

6.Subjects with any neoplastic, metabolic, and cardiovascular disorder or other concurrent medical illness (i.e., type 1 or type 2 diabetes, renal disease, and mal-absorptive disorders, acute and chronic inflammations) confirmed based on medical history, physical examination, and routine laboratory tests, including measurement of oral temperature, white blood cell count and urinalysis.

7.Subjects with known history of hypersensitivity to the study drugs.

8.Alcoholic consumers and smokers

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in the number and size of the ovarian cyst for the two treatment arms. <br/ ><br>•Improvement in clinical features: Menstrual pattern (duration, interval), weight reduction, Hirsutism, Acanthosis nigricans, Acne for the two treatment arms. <br/ ><br>Timepoint: End of the study <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1Change in comorbidities such as diabetes, obesity, hypertension for the two treatment arms <br/ ><br>2Adverse events & relevant abnormal laboratory findings (serious/non-serious, expected/unexpected, related/non-related) for the two treatment arms <br/ ><br>3Percentage of patients with adverse events for the two treatment arms <br/ ><br>4Treatment discontinuation rates: Early discontinuation, discontinuation due to adverse events for the two treatment arms. <br/ ><br>Timepoint: End of the study