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

An Open Label, Multi-center, Prospective, Interventional, Clinical Study to Evaluate Efficacy and Safety of Ayuvigo Forte Capsules in Patients Suffering From Oligospermia - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/06/008799

Enrollment

Registered

2017-06-09

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N461- Oligospermia

Interventions

Intervention1: Ayuvigo Forte Capsule: Ayuvigo Forte Capsule contains Mucona pruriens, Withania somnifera, Tribulus terrestris, Aspargus racemosus, Sida cordifolia, Asteracantha longifolia, Asparagus a

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

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

Measure

Time frame

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

—

Countries

India

Contacts

Public ContactDr Sanjay Tamoli

Target Institute of Medical Education and Research

sanjaytamoli@hotmail.com9322522252

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026