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Clinical study on JP-16 Capsules in impotency

An open label, interventional, multi-center, prospective clinical study to Evaluation of Efficacy and Safety of JP-16 Capsules in Patients Suffering from Mild to Moderate Sexual Dysfunction - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/09/009618
Enrollment
40
Registered
2017-09-04
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: null- erectile dysfunction

Interventions

Intervention1: JP-16 Capsules: JP-16 Capsules contains Keshar, Akarkara, Vang, Vidhara, Javitri, Abhrak Bhasm, Swarna Bang, Makardhwaj, Pushpadanwa Ras, Kapoor and others Dosage and Treatment Duration

Sponsors

Chatarubhuj Pharmaceutical Co
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects who have scored 22 to 25 on the Erectile Function (EF) domain of the International Index of Erectile Function (IIEF) at screening. 2. Subject without any organic cause of Sexual Dysfunction. 3. Subjects should be in an active stable sexual relationship for the duration of 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 disorders that may cause priapism 4. Subjects with history of major psychiatric disorder 5. Subjects with history of central nervous system disorders such as stroke, transient ischemic attacks or spinal cord injury or pelvic surgery 6. Patients with preexisting systemic disease necessitating long-term medications, genetic and endocrinal disorders

Design outcomes

Primary

MeasureTime frame
1.To evaluate efficacy of JP2016 Capsule Erectile function of penis on Erectile function subscale of IIEF Questionnaire 2.To evaluate efficacy of JP2016 Capsule on Hardness of penis on Erection Hardness ScoreTimepoint: Day -3, Day 0, Day 15 and Day 30

Secondary

MeasureTime frame
1.To evaluate efficacy of JP2016 Capsule on Male sexual health on EDITS questionnaire 2.To evaluate efficacy of JP2016 Capsule by assessing Changes in serum testosterone levels 3.To evaluate efficacy of JP2016 Capsule on Global assessment for overall improvement by the investigator and by the patient at the end of the study treatment 4.To evaluate Tolerability of JP2016 Capsule 5.Adverse events 6.Laboratory parametersTimepoint: Day -3, Day 0, Day 15 and Day 30

Countries

India

Contacts

Public ContactDr Sanjay Tamoli

Target Institute of Medical Education and Research

targetinstitute@yahoo.com9322522252

Outcome results

None listed

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