A clinical trial to test the safety and effectiveness of combination therapy of 2 Ayurvedic products from Jammi Pharmaceuticals for treating women with PCOS
- Conditions
- Health Condition 1: E282- Polycystic ovarian syndrome
- Registration Number
- CTRI/2021/07/034951
- Lead Sponsor
- Jammi Pharmaceuticals Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
1.Young women of age between 18 to 40 yrs. diagnosed withPCOS
2.Sub-fertilefemales
3.Polycystic ovaries with exclusion of otheraetiologies
4.Women with normal uterinecavity
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 vitalsigns.
1.Pregnant or lactatingwomen.
2.Subjects with presence of infertility factors other thananovulation
3.Subjectswithpelvicorganicpathologies,presenceofotherpathologiessuchasnon- classical congenital adrenal hyperplasia, Cushing’s syndrome and androgen secretingtumours
4.Subjects with thyroid dysfunction, hyperprolactenemia, androgen secreting neoplasia.
5.Women requiring, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs, or other hormonaldrugs.
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- absorptivedisorders,acuteandchronicinflammations)confirmedbasedonmedical history, physical examination, and routine laboratory tests, including measurement of oral temperature, white blood cell count andurinalysis.
7.Subjects with known history of hypersensitivity to the studydrugs.
8.Alcoholic consumers andsmokers
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •To evaluate the efficacy of Suventris Syrup and CystEvit Tablet combination therapy when compared to standard of care in eviction of ovarian cysts in subjects diagnosed with Poly-Cystic OvarianSyndromeTimepoint: 120 days
- Secondary Outcome Measures
Name Time Method •To evaluate the number of subjects showing normal ovulation after Suventris Syrup and CystEvit Tablets combination therapy when compared to stand ofcare.Timepoint: 120 days