Evidence map›Paper›PMID 40151736›Full record

ArticleCureus2025

A Randomized, Multicenter, Double-Blind, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of a Polyherbal Formulation in Men With Erectile Dysfunction.

Gayatri P Ganu, Pramod K Kolsure, Sanman S Kolhe, Aditya Dev, Somesh S Shintre, Shrikant G Dhavale, Vinod K Kuber, Dheeraj H Nagore, Sriram Padmanabhan

Abstract read
In one paragraph

Article in Cureus, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Gayatri P GanuDepartment of Pharmacology, Mprex Healthcare Pvt. Ltd., Pune, IND.
Pramod K KolsureDepartment of Formulation and Development, SAVA Healthcare Limited, Pune, IND.
Sanman S KolheDepartment of Research and Development, SAVA Healthcare Limited, Pune, IND.
Aditya DevDepartment of Research and Development, SAVA Healthcare Limited, Pune, IND.
Somesh S ShintreDepartment of Research and Development, SAVA Healthcare Limited, Pune, IND.
Shrikant G DhavaleDepartment of Formulation and Development, SAVA Healthcare Limited, Pune, IND.
Vinod K KuberDepartment of Formulation and Development, SAVA Healthcare Limited, Pune, IND.
Dheeraj H NagoreDepartment of Pharmacology, Mprex Healthcare Pvt. Ltd., Pune, IND.
Sriram PadmanabhanDepartment of Biochemistry, SAVA Healthcare Limited, Pune, IND.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction Erectile dysfunction (ED) is a prevalent condition impacting men worldwide, often causing significant reductions in quality of life, emotional well-being, and relationship satisfaction. ED currently affects approximately 100 million men worldwide, with its prevalence projected to rise to 320 million by 2025, particularly in developing nations. Notably, nearly half of all men aged 40 and above experience some degree of ED, underscoring its widespread impact on male health. Existing treatments, while available, frequently fall short in terms of efficacy and safety, underscoring the demand for innovative and safer therapeutic alternatives. Methods Eighty-five participants completed the study and were randomly assigned to receive either the test treatment (polyherbal formulation) or a placebo, utilizing a computer-generated randomization list. The study protocol included screening (up to 14 days prior), baseline assessment (Day 0), and follow-up visits at day 30, day 60, and day 90 (± 5 days), allowing for thorough monitoring of outcomes. Results The test group exhibited significantly greater improvements in erectile function (92.2% vs. 34.8%), along with enhancements in sexual desire, orgasmic function, intercourse satisfaction, and overall satisfaction compared to the placebo group. Quality of erection scores also showed marked improvement in the test group. Additionally, serum testosterone levels increased by 46.5% in the test group compared to a mere 3.3% in the placebo group. Adverse events were mild and occurred with similar frequency in both groups (9.3% vs. 9.5%). Overall, the test group demonstrated robust efficacy and a favorable safety profile, presenting a promising therapeutic option for the management of ED. Conclusion The in-vitro phosphodiesterase type 5 (PDE5) assay and clinical study demonstrate the effectiveness of test intervention in managing ED and improving sexual health, with a favorable safety profile. Its synergistic herbal ingredients enhance efficacy, making it a promising solution in the management of ED.

Indexed as

erectile dysfunctionpde-5polyherbal formulationsexual functiontestosterone levels

Identifiers

PMID40151736
PMCPMC11948292

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.