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Clinical Trials/CTRI/2019/11/022183
CTRI/2019/11/022183
Completed
Phase 2

An Open Label, Multi-center, Prospective Clinical study to Evaluate Efficacy and Safety of Ayuvita Capsule in patients suffering from PCOS - NI

Welex Laboratories Pvt Ltd0 sites25 target enrollmentTBD
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Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Welex Laboratories Pvt Ltd
Enrollment
25
Status
Completed
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
June 10, 2021
Last Updated
3 years ago
Study Type
Interventional

Investigators

Sponsor
Welex Laboratories Pvt Ltd

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

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