Clinical study of â??SHL 1066â?? Tablet in patient with low sperm count

Phase 2

Conditions: Health Condition 1: N461- Oligospermia

Registration Number: CTRI/2018/10/016031

Lead Sponsor: SAVESTA LIFESCIENCES INC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1)Sperm count 1 million to less than 15 million/ml with normal sperm morphology

2)Subjects capable of giving written informed consent, which includes compliance with protocol.

3)Agree not to use any other treatment for erectile dysfunction (ED).

4)Willing to give specimen of semen before & at the end of the clinical trial

Exclusion Criteria

1.Subjects having azoospermia, of aspermia, or necrospermia.

2.Subjects with clinical diagnosis of Varicocele & Hydrocele

3.Subjects with history of undescended testis

4.Subjects with inguinal hernia or other clinical condition on physical examination which may have relation to low sperm count

5.Subjects with accessory gland infection

6.Subjects with severe form of sexual dysfunction

7.Subjects with history or presence of significant alcoholism or drug abuse within the past 1 year.

8.Subjects with any clinically significant laboratory or ECG findings during screening.

9.Subjects who underwent surgery within last 4 weeks or planned major surgery within next 3 months from the date of screening.

10.Subjects who have participated in any drug research study within past 3 months.

11.Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his participation in, and completion of the protocol

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in the total number of sperm cells per milliliter of seminal fluidTimepoint: Screening Visit (up to -14 days), Baseline Visit (Day 0), Visit 1 (Day 30 days), Visit 2 (Day 60 days), Visit 3 (Day 90 days)

Secondary Outcome Measures

Name	Time	Method
1.Comparison of changes in the total number of sperm cells per ml of seminal fluid from baseline to 3 months between the groups. <br/ ><br>2.Total Semen volume per ejaculate, percentage of total motile sperms, semen volume, semen parameters from baseline to 3 months <br/ ><br>3.Serum total testosterone, LH, FSH, estradiol level from baseline to 3 months. <br/ ><br>4.Erectile function domain, IIEF-IS, IIEF-OS domain from baseline to 3 months <br/ ><br>5.Vitals and laboratory parameters from baseline to 3 months <br/ ><br>Timepoint: Screening Visit (up to -14 days), Baseline Visit (Day 0), Visit 1 (Day 30 days), Visit 2 (Day 60 days), Visit 3 (Day 90 days)