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CTRI Number  CTRI/2022/03/041069 [Registered on: 14/03/2022] Trial Registered Prospectively
Last Modified On: 08/07/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical study to evaluate the efficacy and safety of Libidolyn® when compared with placebo in improving sexual health of male subjects. 
Scientific Title of Study   A double-blind, randomised, placebo controlled, parallel group study to evaluate the efficacy and safety of Libidolyn® in improving erectile function and maintain normal sexual health. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
iVRS-CD-20-011 Version 01 dated 10 Feb 2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Narayanaswamy V 
Designation  Principal Investigator 
Affiliation  Narayana Super Speciality Hospitals 
Address  Gynecology Department Room No 11 Ground floor No 6 7 and 8 18th Cross 4th Main Malleswaram West Bengaluru 560055 Karnataka India

Bangalore
KARNATAKA
560055
India 
Phone  9448053952  
Fax    
Email  drnarayanavagus@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Channabasavanna G Halasagi 
Designation  Medical Monitor 
Affiliation  In Vitro Research Solutions Pvt. Ltd. 
Address  Clinical Development Department Room No 301, 3rd floor No 22 and 23 Kodigehalli Main Road Sahakar Nagar Hebbal Bengaluru 560092 KARNATAKA India

Bangalore
KARNATAKA
560092
India 
Phone  6366947473  
Fax    
Email  channa@ivrs.org.in  
 
Details of Contact Person
Public Query  
Name  T Vijay Bhaskar 
Designation  Director - Clinical Development 
Affiliation  In Vitro Research Solutions Pvt. Ltd. 
Address  Clinical Development Department Room No 301 3rd Floor No 22 and 23 Kodigehalli Main Road Sahakar Nagar Hebbal Bengaluru 560092 KARNATAKA India

Bangalore
KARNATAKA
560092
India 
Phone  6366575282  
Fax    
Email  vijay@ivrs.org.in  
 
Source of Monetary or Material Support  
Narayana Super Speciality Hospitals 6 7 and 8 18th Cross 4th Main Malleswaram West Bengaluru 560055 Karnataka India 
 
Primary Sponsor  
Name  Herbalyn Lifesciences Inc 
Address  Bayside Technology Park 46500 Fremont Blvd#706 Fremont, CA 94538, USA 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
In Vitro Research Solutions iVRS Pvt Ltd  No 22 and 23 Kodigehalli Main Road Sahakar Nagar Hebbal Bengaluru 560092 KARNATAKA India 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Narayanaswamy V  Narayana Super Speciality Hospitals  Gynecology Department Room No 11 Ground floor No 6 7 and 8 18th Cross 4th Main Malleswaram West Bengaluru 560055 Karnataka India
Bangalore
KARNATAKA 		 9448053952

drnarayanavagus@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Vagus Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N529||Male erectile dysfunction, unspecified,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Placebo, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 100(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: NA
2Intervention ArmDrugOther than Classical(1) Medicine Name: Libidolyn (Herbal Supplement) capsules, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 100(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: NA
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  50.00 Year(s)
Gender  Male 
Details  a. Male subjects aged 25 to 50 years in general good health having a stable female partner for past three months.
b. At least a 3-month history of erectile dysfunction (ED).
c. Are able to read, understand and provide signed informed consent.
d. Have an International Index of Erectile Function-Erectile Function (IIEF-EF) domain score that is greater than or equal to 12 and less than 18 (having Moderate severity of Erectile Dysfunction) at Randomization visit.
e. The subjects are anticipated to have the same female sexual partner during the study, who is willing to be associated with the male subjects’ attempts and complete study measures during the study.
f. Agree not to use any other erectile dysfunction (ED) treatment, including herbal therapy during the double-blind treatment period and for 96 hours after the end of the study. 
 
ExclusionCriteria 
Details  a. Have an IIEF-EF domain score of greater than or equal to 26 at screening.
b. Present with ED caused by other primary disorders such as hypertension, diabetes mellitus, obesity or other untreated/inadequately treated endocrine disease including the psychogenic ED.
c. History of radical prostatectomy or other pelvic surgery or penile implant, or a clinically significant penile deformity, in the opinion of the investigator
d. Exhibit evidence of clinically significant renal insufficiency or hepatobiliary disease, or significant cardiac history as determined by the investigator
e. Currently receiving treatment with nitrates, cancer chemotherapy, vasodilators, drugs for neurological conditions or antiandrogens
f. Subjects with mental disorders including performance anxiety
g. History of tobacco, drug and alcohol abuse including current smoker
h. Subject who has participated in a clinical study within the last 30 days prior to entering this study.
i. Subject with hypersensitivity to any of the study products. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Percentage of Participants Having an International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Greater Than or Equal to 26 at 90 day Endpoint.  Baseline to Day 90 
 
Secondary Outcome  
Outcome  TimePoints 
• Change From Baseline to 90 days Endpoint in the International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score, Intercourse Satisfaction (IIEF-IS) Domain Score, Overall Satisfaction (IIEF-OS) Domain Score
• Change From Baseline to 90 day Endpoint serum testosterone & serum prolactin.
• Proportion of subjects with adverse events (including clinically significant abnormality in laboratory values and vital signs)
• Subject’s global assessment of therapy at end of the treatment visit. 		 Baseline to Day 90 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/03/2022 
Date of Study Completion (India) 29/07/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="15" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This is a study to understand the efficacy and safety of poly herbal (Libidolyn Capsules) for erectile function and maintain normal sexual health in subjects in comparison with placebo. The duration of the study is 97 days (including screening). 
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