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Clinical Trials/CTRI/2023/08/056245
CTRI/2023/08/056245Not yet recruitingPhase 3

To evaluate efficacy of Traditional Ayurvedic Formulation (Divya Santati Sudha) in female infertility: an observational, single-arm, prospective study.

Patanjali Research Institute governed by Patanjali Research Foundation Trust2 sites in 1 country69 target enrollmentStarted: August 31, 2023Last updated:
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Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Sponsor
Enrollment
69
Locations
2
Primary Endpoint
To assess the quality of the life and problem related infertility of the subject by the help of Fertility quality of life (FertiQoL) and The fertility problem inventory.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This study is single-arm, open-label, Prospective study and observational study. Eligible patients will receive 540 mg of Divya Santati Sudha tablet as per prescribed by Ayurvedic practitioner. The outcomes will be to evaluate the efficacy and safety of Divya-Santati-Sudha Tablet (Traditional Indian Ayurvedic Medicine) in patients with infertility and to assess the quality of the life and problem related infertility of the subject by the help of Fertility quality of life (FertiQoL) and The fertility problem inventory.

Study Design

Study Type
Interventional
Allocation
Not Applicable
Masking
Open Label

Eligibility Criteria

Ages
21.00 Year(s) to 45.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • •Clinically diagnosed with Primary or secondary infertility.
  • •Availability and willingness to provide consent.

Exclusion Criteria

  • •Patient known to have any Malignancies, chronic Hyper/hypothyroidism.
  • •Patient diagnosed with congenital uterine defects.
  • •Male partner with abnormal seminal analysis and unwillingness to get treated.
  • •Participant habituated to alcohol consumption, smoking or any other substance abuse.
  • •The subjects not willing to provide consent.

Outcomes

Primary Outcomes

To assess the quality of the life and problem related infertility of the subject by the help of Fertility quality of life (FertiQoL) and The fertility problem inventory.

Time Frame: Baseline, 30 day, 60 day and 90 day.

Secondary Outcomes

  • To assess the quality of the life and problem related infertility of the subject by the help of Fertility quality of life (FertiQoL) and The fertility problem inventory.(Baseline, 30 day, 60 day and 90 day.)

Investigators

Sponsor
Patanjali Research Institute governed by Patanjali Research Foundation Trust
Sponsor Class
Research institution

Study Sites (2)

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