CTRI/2024/10/075381 [Registered on: 16/10/2024] Trial Registered Prospectively
Last Modified On:
14/02/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug Ayurveda
Study Design
Single Arm Study
Public Title of Study
Clinical Study on the Effectiveness of Arunveda Kondrion and Luxury High Power Kits for Treating Erectile Dysfunction
Scientific Title of Study
An Open-Label, Single-Centered Clinical Study Investigating the Efficacy of Combined Arunveda Kondrion Kit and Arunveda Luxury High Power Kit For Vasculogenic Erectile Dysfunction
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
CTSRS/2407 Version No. 1.0 dated 06 May 2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
DR MANJUNATH U
Designation
Principal Investigator
Affiliation
Currex Hospital Bangalore
Address
Ground floor, OPD 5, No 55 , 56, Seegehalli Main Road, Bhoo Samartha Layout, Seegehalli, KS Halli, Bengaluru, 560049 Karnataka India
(1) Medicine Name: Kondrion Plus, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: 1 Capsule twice a day after meals.(2) Medicine Name: Narsingh Power X Pro, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 0(NA), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Application on penis for 10 mins at night.(3) Medicine Name: Testo Booster, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: 1 capsule twice a day after meals.(4) Medicine Name: Narsingh Tila Oil, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 0(NA), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Application on penis for 10 mins at night.(5) Medicine Name: Gastriglex Capsule, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 2(NA|), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
Inclusion Criteria
Age From
20.00 Year(s)
Age To
60.00 Year(s)
Gender
Male
Details
1. Male subjects between the ages of 20 to 60 years.
2. Patients willing to participate and give informed consent.
3. Patients not having many
complications or many secondary infections.
3. Participants with serum testosterone levels between 280 and 350 ng per dl Established
diagnosis of erectile dysfunction (ED) for over 6 months and less than 5 years, had a baseline
IIEF EF score between 11 and 25.
4. Those who were in a stable relationship for over 5. months with a minimum of 2 sexual
attempts per month for at least 1 month prior to enrollment.
ExclusionCriteria
Details
1. Hypogonadism or anatomical deformity of the penis such as severe penile fibrosis.
2. History of significant pathological cardiovascular conditions such as congestive heart
failure, lifethreatening arrhythmia or ischemic heart disease
3. Continuing history of alcohol and or drug abuse.
4. Subjects with neuromuscular disorders.
5. Subjects with secondary hypertension
6. Cases with severe diabetic complications such as cardiac disease, nephropathy,
and foot ulcer.
7. Participation in other clinical trials.
8. Unwilling or unable to sign the informed consent.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
On-site computer system
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
1. To evaluate increase in blood flow, blood flow retention and visible veins on organ.
2. To evaluate blockage revival.
3. To evaluate the increase in Testosterone levels.
Day 1, Day 10, Day 20, Day 30
Secondary Outcome
Outcome
TimePoints
1. To investigate the general immune functions
2. To evaluate changes in energy levels and libido.
3. To evaluate improvement in mood and stress levels.
Day 1, Day 10, Day 20, Day 30
Target Sample Size
Total Sample Size="50" Sample Size from India="50" Final Enrollment numbers achieved (Total)= "50" Final Enrollment numbers achieved (India)="50"
Phase of Trial
Phase 3
Date of First Enrollment (India)
21/10/2024
Date of Study Completion (India)
23/11/2024
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Date Missing
Estimated Duration of Trial
Years="0" Months="0" Days="30"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Completed
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Summary and Purpose of the Study Erectile dysfunction is a condition characterized by the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. It is most commonly associated with vascular issues, where the blood flow to and from the penis is impaired due to blockages or other physiological factors. This condition is highly age dependent and is closely linked to cardiovascular health, making early diagnosis crucial for preventing more serious cardiovascular events.
The causes of ED are generally categorized into organic, psychogenic, or mixed. Among these, organic causes account for the majority of cases, with vasculogenic ED being the most prevalent. Vasculogenic ED is associated with traditional cardiovascular risk factors, such as hypercholesterolemia and atherosclerosis, and may lead to severe cardiovascular events like myocardial infarction or ischemic stroke. Current treatment approaches for ED, such as penile revascularization and lifestyle modifications, have shown limited success, particularly in cases of cavernosal fibrosis and veno-occlusive dysfunction.
Shilajit, a traditional remedy known for its rejuvenating properties, along with other Ayurvedic ingredients like Ashwagandha, Shatavari, and Shudh Shilajit, has shown promise in addressing these issues. The Arunveda Luxury High Power Kit, containing Shudh Shilajit and Shwet Musli, and the Kondrion Kit, a blend of Ashwagandha, Shatavari, and other herbs, are formulated to improve male sexual health by boosting stamina, enhancing endurance, and promoting overall vitality.
Purpose of the Study The present clinical study is designed to evaluate the efficacy and safety of the Arunveda Luxury High Power Kit and the Kondrion Kit in the treatment of vasculogenic erectile dysfunction. The study aims to reconfirm the potential benefits of these Ayurvedic products in improving sexual performance, reducing symptoms of ED, and enhancing overall male sexual health. By assessing the therapeutic effects of these natural remedies, the study seeks to offer an alternative approach to managing vasculogenic ED, potentially improving the quality of life for affected individuals.
Results and Discussion:
The study demonstrated the efficacy and safety of the Arunveda Kondrion Kit and Arunveda Luxury High Power Kit in managing vasculogenic erectile dysfunction (VED). Significant improvements were observed in blood flow retention, visible veins, blockage revival, and serum testosterone levels (p < 0.05). Participants reported enhanced energy levels, libido, and mood, along with reduced stress levels and stable immune function. The intervention also led to improvements in erectile function and overall quality of life. No adverse events (AEs) or serious adverse events (SAEs) were reported, and the compliance rate was 100%, confirming the excellent tolerability of the investigational products.
Additionally, the study demonstrated statistically significant improvements in key physiological and psychological parameters associated with vasculogenic erectile dysfunction. Primary endpoint results showed enhanced vascular health, with blood flow retention and visible veins improving significantly (p < 0.05), blockage revival scores increasing (p < 0.05), and serum testosterone levels rising from 258.86 ng/dL to 266.36 ng/dL (p < 0.05), suggesting a positive hormonal impact. Secondary endpoint findings indicated significant enhancements in energy levels, libido, and psychological well-being, with 86% of participants reporting improvements in mood and stress levels (p < 0.05). General immune function remained stable, with 98% of participants showing no increase in infections, and 86% reporting increased physical activity. The intervention was well-tolerated, with no adverse events (AEs) or serious adverse events (SAEs) reported and a 100% compliance rate.
These findings support the use of natural Ayurvedic formulations as a safe and effective alternative for improving male sexual health, hormonal balance, and overall well-being.