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A clinical study to assess the Efficacy and Safety of SAW-1720 in Benign Prostate Hyperplasia patients

A Randomized, Double-Blind, Two-arm, Study to Evaluate the Anti-Inflammatory Properties, Over all Efficacy and Safety of SAW-1720 in Comparison with Saw Palmetto Oil in the Treatment of Benign Prostate Hyperplasia.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/09/027521
Enrollment
60
Registered
2020-09-01
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: N401- Benign prostatic hyperplasia withlower urinary tract symptoms

Interventions

Intervention1: SAW-1720: Daily oral administration of 2 capsules of SAW-1720 for 84 days Control Intervention1: Saw Palmetto oil: Daily oral administration of 2 capsules of Saw Palmetto oil for 84 day

Sponsors

Akay Natural Ingredients Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.At screening, subject has an International prostatic symptom score greater than 7 2.BPH subjects with a history of recurrent lower urinary tract infection for at least 2 months 3.Must be willing and able to give informed consent and comply with the study procedures

Exclusion criteria

Exclusion criteria: 1 Has a history of prostate cancer or carcinoma of the prostate or subjects with known history of serum PSA concentration > 4 ng/ml must have prostate cancer ruled out to the satisfaction of the investigator. 2 Has a residual void volume > 200 ml 3 History of Neurogenic bladder dysfunction, Has bladder neck contracture or urethral stricture,Serious medical co-morbidities like uncontrolled diabetes, hypertension and cardio vascular disorders, neuropathy, liver damage, renal failure or respiratory tract infection.Any prior surgery which could induce dysuria,Use of any other herbal medications for treatment of BPH, associated symptoms and Erectile Dysfunction in past 1 month,Diuretics or drugs with antiandrogenic or alpha-receptor properties in the preceding 3 months. 4 Subjects allergic to herbal products or any component of the study product 5 Known HIV or Hepatitis B positive or any other immuno-compromised state 6 Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study 7 Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study

Design outcomes

Primary

MeasureTime frame
Efficacy of SAW-1720 in comparison with Saw palmetto oil in the treatment of benign prostate hyperplasia (BPH)Timepoint: Day 0,Day 28,Day 56,Day 84—

Secondary

MeasureTime frame
To assess the safety and tolerability of SAW-1720.Timepoint: Day 0,Day 28,Day 56,Day 84—

Countries

India

Contacts

Public ContactJestin V Thomas

Leads Clinical Research and Bio Services Pvt. Ltd

jestin.leadsclinbio@gmail.com9845125293

Outcome results

None listed

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