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 个研究点分布在 1 个国家目标入组 69 人开始时间: 2023年8月31日最近更新: 2023年7月8日

试验速览

阶段: 3 期
状态: 尚未招募
发起方
入组人数: 69
试验地点: 2
主要终点: 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.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Not Applicable
盲法: Open Label

入排标准

年龄范围: 21.00 Year(s) 至 45.00 Year(s)（—）
性别: Female

入选标准

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

排除标准

•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.

结局指标

主要结局

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.

时间窗: Baseline, 30 day, 60 day and 90 day.

次要结局

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.)

研究者

发起方

Patanjali Research Institute governed by Patanjali Research Foundation Trust

申办方类型

Research institution

研究点 (2)

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