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

A prospective, open-labelled, comparative clinical study to evaluate the safety and efficacy of the combination therapy of Syrup PCOS001 and Capsule PCOS002 compared with standard-of-care in adult women diagnosed with poly-cystic ovarian syndrome. - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/08/072073

Enrollment

200

Registered

2024-08-07

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

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

Interventions

None listed

Eligibility

Inclusion criteria

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

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, CushingÃ¢â?¬•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

Design outcomes

Primary

Measure	Time frame
Reduction in the number and size of the ovarian cyst for the two treatment arms. Ã¢â?¬Â¢Improvement in clinical features: Menstrual pattern (duration, interval), weight reduction, Hirsutism, Acanthosis nigricans, Acne for the two treatment arms. Timepoint: End of the study	—

Secondary

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

Measure

Time frame

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

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Countries

India

Contacts

Public ContactMs Sathyavathi LM

SAMAHITHA RESEARCH SOLUTIONS

mrd@samahitha.com9816333352

Outcome results