Clinical study on Ayuvita Forte Capsule in irregular periods with cysts in ovary.

Phase 2

Completed

• Conditions: Health Condition 1: E282- Polycystic ovarian syndrome

• Registration Number: CTRI/2019/11/022183
• Lead Sponsor: Welex Laboratories Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-06-10
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

1.Subjects diagnosed with PCOS by ppresence of two of the of the three Rotterdam criteria: Oligomenorrhea, anovulation; Hyperandrogenism; and the observation of polycystic ovaries by USG of the Lower Abdomen and Pelvis.

2.Subjects willing to follow the procedures as per the study protocol and

voluntarily signing informed consent form.

Exclusion Criteria

1. Subjects having organic causes of menstrual abnormalities like uterine myeloma, pelvic inflammatory disease adenomyosis, polyps, fibroids, endometriosis, cervical erosion (as diagnosed by USG lower abdomen and pelvis).

2. Subjects having clinical and/or biochemical signs of severe hyperandronism

3. Subjects having systematic illness like uncontrolled hypertension, uncontrolled diabetes mellitus, renal disease, tuberculosis, liver disorder, coagulation disorder, hypothyroidism, hyperthyroidism, Hirsutism, Addisonââ?¬•s disease and/or Cushing disease.

4. Subjects with one year of history of child birth

5. History of genitor-urinary surgery, and/or other major medical or surgical diseases; which can affect or related with study outcomes.

6. Nursing, pregnant or lactating women.

7. Use of corticosteroids or hormones or hormonal drugs within last 1 months of screening visit.

8. Use of any other investigational drug within 1 month prior to screening visit.

9. Patient having known hypersensitivity to any ingredient of the study drug.

10. Pregnant and Lactating females.

11. Any other conditions which in the opinion of investigator will place the subject at risk or will influence the conduct of study or interpretation of results

Study & Design

• Study Type: Interventional
• Study Design: Not specified