Clinical study on Ayuvigo Forte Capsules in patients with less sperm count

Phase 2

Completed

• Conditions: Health Condition 1: N461- Oligospermia

• Registration Number: CTRI/2017/06/008799
• Lead Sponsor: Welex Laboratories Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-10-06
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

1. Sperm concentration less than 15 million per ml (WHO laboratory manual for the examination and processing of human semen, Fifth Edition, 2010) with normal sperm morphology, with or without sperm total motility less than 40 percent or sperm forward progressive motility less than 32 percent.

2. Subjects should be in an active stable sexual relationship for the duration of study

3. Subjects who are willing to give informed consent and ready to comply with the protocol

4. Subjects who are ready to provide regular follow ups till the completion of the study

Exclusion Criteria

1. Subjects with major illnesses and sexual dysfunction due to anatomical, surgical or pharmacological causes

2. Subjects with total erectile failure or any other sexual disorder

3. Subjects with history of central nervous system disorders such as stroke, transient ischemic attacks or spinal cord injury or pelvic surgery

4. Subjects with hypotension or uncontrolled hypertension, uncontrolled diabetes, hepatic impairment, renal impairment or hematological disorders

5. Subjects with clinical symptoms of scrotal varicocele and confirmed with USG and colour Doppler will be excluded from the study

6. Subjects with significant abnormal laboratory parameters

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate efficacy and safety of Ayuvigo Forte Capsules in patients suffering from Oligospermia by assessing Changes in total sperm count.Timepoint: Day -7, Day 0, Day 90

Secondary Outcome Measures

Name	Time	Method
1. Changes in semen volume. <br/ ><br>2. Changes in Sperm motility with progressive sperm motility. <br/ ><br>3. Changes in total number of spermatozoa per ejaculate, Sperm Morphology, viability of spermatozoa. <br/ ><br>4. Changes in serum total and free testosterone, serum LH, FSH <br/ ><br>5. Spontaneous achieved pregnancies. <br/ ><br>6. Change in subjective parameters <br/ ><br>7. Global assessment for overall improvement by investigator and patient. <br/ ><br>8. Tolerability of study drug <br/ ><br>9. Laboratory parametersTimepoint: Day -7, Day 0, Day 30, Day 60, Day 90 <br/ ><br>