| CTRI Number |
CTRI/2024/07/071171 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
29/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the Efficacy and Safety of study product i.e., LYCO3 in Male Subjects who Suffering from Erectile Dysfunction |
|
Scientific Title of Study
|
A Single Centric, Open-Label, Non-Randomized Clinical Study to evaluate the Efficacy and Safety of LYCO3 in Male Subjects Suffering from Erectile Dysfunction |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Srinivas B V |
| Designation |
Senior Consultant Andrologist & Urologist |
| Affiliation |
Shridevi Institute of Medical Sciences and Research Center |
| Address |
Ayuryog Clinic
Room No. 1, 1964/1, 20th Main, 7th Cross, J. P. Nagar - 560078, Bangalore, Karnataka
Bangalore
KARNATAKA
560078
India |
| Phone |
9844710400 |
| Fax |
|
| Email |
drsrinivasbv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Hasan Ali Ahmed |
| Designation |
Director |
| Affiliation |
Xplora Clinical Research Services Pvt. Ltd. |
| Address |
#252,13th Cross, Wilson Garden, Bangalore -560027
Bangalore
KARNATAKA
560027
India |
| Phone |
9886012598 |
| Fax |
|
| Email |
hasan@xplorahealth.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Manik Chaudhuri |
| Designation |
Project Manager |
| Affiliation |
Xplora Clinical Research Services Pvt. Ltd. |
| Address |
#252, 13th Cross, Wilson Garden, Bangalore- 560027
Bangalore
KARNATAKA
560027
India |
| Phone |
9738651205 |
| Fax |
|
| Email |
manik@xplorahealth.com |
|
|
Source of Monetary or Material Support
|
| Nutragen Pharma Pvt. Ltd.
51/1055, Industrial Estate, Papanamcode, Thiruvananthapuram, Kerala 695019, India |
|
|
Primary Sponsor
|
| Name |
Nutragen Pharma Pvt. Ltd. |
| Address |
51/1055, Industrial Estate, Papanamcode, Thiruvananthapuram, Kerala 695019, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Srinivas B V |
Ayuryog Clinic |
Room no.1, 1964/1, 20th Main, 7th Cross, J.P. Nagar - 560078
Bangalore
KARNATAKA |
9844710400
drsrinivasbv@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pranav Diabetes Center Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N529||Male erectile dysfunction, unspecified. Ayurveda Condition: KLAIBYAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: LYCO3, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 982(mg), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
1) Male participants aged above 18 years who are in good health.
2) Participants with a Body Mass Index (BMI) less than 40.
3) Individuals with a positive Androgen Deficiency in Aging Males (ADAM) questionnaire score, defined as an affirmative response ("yes") to either of the following questions: "Do you have a decreased sex drive/libido?" or "Are your erections less strong?" or a positive response to any three other questions on the ADAM questionnaire.
4) Individuals with an International Index of Erectile Function (IIEF) assessment score between 11-25.
5) Individuals willing to engage in at least four sexual encounters over next 8-week period.
6) Men who are committed to refraining from the use of phosphodiesterase 5 inhibitors (e.g., Viagra, Levitra, Cialis), supplements, or other herbal supplements throughout the study duration.
7) Subjects willing to provide written informed consent and adhere to all study procedures. |
|
| ExclusionCriteria |
| Details |
1) Individuals with current or previous history of prostate or testicular cancer.
2) Participants with a past surgical history of prostatectomy.
3) Men who have received past or current treatment for erectile dysfunction, including intracavernosal injections or penile prosthesis.
4) Use of steroids within the past 3 months, including prednisone, cortisone injections, and inhaled steroids.
5) History of or current use of anabolic steroids (e.g., testosterone), testosterone analogs (e.g., DHEA, DHEAS), antidepressants, or anti-androgen medications (e.g., aldactone, tagamet, estrogens).
6) History of spinal cord injury; and use of systemic anticoagulants (e.g., coumadin, clopidogrel).
7) Presence of clinically significant medical conditions, including but not limited to cardiovascular, neurological, psychiatric, hepatic, renal, immunological, endocrine disorders (such as uncontrolled diabetes or thyroid disease), or haematological abnormalities.
8) Active smokers or individuals with a history of high alcohol intake (2 standard drinks per day).
9) Known hypersensitivity to herbal drugs, nutritional supplements, or foods. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Change in International index of erectile function (IIEF) scores from screening to different assessment points.
2) Change in Erection Hardness Score (EHS) from screening to different assessment points. |
Day 0, Day 45 and Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Change in serum testosterone levels from screening to end of the study.
2) Change in ADAM questionnaire score from screening to end of the study.
3) The change in vital signs (blood pressure, pulse rate, body temperature) from screening to the end of the study.
4) The changes in haematological (CBC), liver (Sr. SGPT) and kidney function (serum creatinine) parameters from screening to the end of the study.
5) Occurrence of the treatment-related adverse events during study period. |
Day 0, Day 45 and Day 90 |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "18"
Final Enrollment numbers achieved (India)="18" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
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)?
Response - NO
|
|
Brief Summary
|
A Single Centric,
Open-Label, Non-Randomized Clinical Study to evaluate the Efficacy and Safety
of LYCO3 in Male Subjects Suffering from Erectile Dysfunction study. Mainly, to assess the safety and
efficacy of LYCO3 in the clinical improvement in Erectile Function in male subjects. Study population is total of 20 Male subjects will
be enrolled and study duration is 90 days. Individuals with a positive Androgen Deficiency in Aging Males (ADAM)
questionnaire score, defined as an affirmative response ("yes") to
either of the following questions: "Do you have a decreased sex
drive/libido?" or "Are your erections less strong?" or a
positive response to any three other questions on the ADAM questionnaire and Individuals with an International Index of Erectile Function (IIEF)
assessment score between 11-25 will be enrolled into the study. Change in International index of erectile
function (IIEF) scores & Change in Erection Hardness Score (EHS) from screening to different assessment points will be assessed. Also, Change in serum testosterone levels from screening
to end of the study, Change in ADAM questionnaire score from screening
to end of the study, The change in vital signs (blood pressure,
pulse rate, body temperature) from screening to the end of the study, The changes in haematological (CBC), liver
(Sr. SGPT) and kidney function (serum creatinine) parameters from screening to
the end of the study will be assessed. LYCO3, a supplement encapsulating Coenzyme Q10,
Lycopene, Tocopherol, Beta-carotene, and Omega-3 Fatty Acids, is formulated to
address nutritional deficiencies crucial for overall health. This blend of
essential nutrients offers a multifaceted approach to support various bodily
functions. By exploring
the impact of LYCO3 on erectile function, vascular health, and quality of life,
this study aims to contribute valuable insights into novel therapeutic
strategies for managing ED and improving sexual health outcomes.
|