To evaluate efficacy of Traditional Ayurvedic Formulation (Divya Santati Sudha) in female infertility.

Phase 3

Not yet recruiting

• Conditions: Female infertility, unspecified,

• Registration Number: CTRI/2023/08/056245
• Lead Sponsor: Patanjali Research Institute governed by Patanjali Research Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-07-08
• Study Start: 2023-08-31

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 69

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Patanjali Wellness Center; 🇮🇳 Hardwar, UTTARANCHAL, India

Patanjali Yoggram; 🇮🇳 Hardwar, UTTARANCHAL, India

Patanjali Wellness Center

🇮🇳Hardwar, UTTARANCHAL, India

Dr Devika Balagopalan

Principal investigator

7293549081

devika.balagopalan@patanjali.res.in