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CTRI Number  CTRI/2024/05/067134 [Registered on: 10/05/2024] Trial Registered Prospectively
Last Modified On: 01/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study
Modification(s)  		 A study on HSLG-032303 capsules in treating Low Libido in adult males. 
Scientific Title of Study
Modification(s)  		 An Open-Label, Single Arm Clinical Study to Evaluate the Safety, Efficacy and Tolerability of HSLG-032303 in Healthy Adult Males with Low Libido. 
Trial Acronym  NIL 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
HWC/MSCD/PP/009/2024 Version 1.1 Dated: 28th June 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Praveen B Joshi 
Designation  Consultant Physician 
Affiliation  Joshis Andrology & Urology Centre 
Address  No 567, 21st Main, 20th Cross, A block Sahakaranagar

Bangalore
KARNATAKA
560092
India 
Phone  8762292039  
Fax    
Email  drpraveenjoshi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anindya Dasgupta 
Designation  Scientific Manager 
Affiliation  Himalaya Wellness Company 
Address  Room No 301, 3rd Floor Medical Services and Clinical Development(R&D), Makali Tumkur Road

Bangalore
KARNATAKA
562162
India 
Phone  8067549920  
Fax    
Email  dr.anindya@himalayawellness.com  
 
Details of Contact Person
Public Query  
Name  Dr Soorya Narayan H 
Designation  Manager-Clinical Operations 
Affiliation  Himalaya Wellness Company 
Address  Room No 301, 3rd Floor Medical Services and Clinical Development(R&D), Makali Tumkur Road

Bangalore
KARNATAKA
562162
India 
Phone  8105466999  
Fax    
Email  dr.sooryanarayan.h@himalayawellness.com  
 
Source of Monetary or Material Support  
Himalaya Wellness Company Room No 301, 3rd Floor Medical Services and Clinical Development(R&D), Makali Tumkur Road Karnataka 562162, India  
 
Primary Sponsor  
Name  Himalaya Wellness Company  
Address  Room No 301, 3rd Floor Medical Services and Clinical Development(R&D), Makali Tumkur Road Karnataka 562162, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Praveen B Joshi  Joshis Andrology & Urology Centre  776, 1st and 2nd floor, Srikrishna complex, Sahakaranagar A block, Landmark: Opposite Ganesha temple
Bangalore
KARNATAKA 		 8762292039

drpraveenjoshi@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Pranav Diabetes Center Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:R688||Other general symptoms and signs. Ayurveda Condition: KLAIBYAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Shilajit Gold, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 450(mg), Frequency: bd, Bhaishajya Kal: Grasa bhakta/Sagrasa, Duration: 28 Days, anupAna/sahapAna: Yes(details: -), Additional Information: 1 capsule twice daily with milk or water or as directed by a physician.
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  50.00 Year(s)
Gender  Male 
Details  1.Male subjects aged 21 to 50 years with general good health.
2.Healthy subjects as determined by the investigator based on a medical evaluation including medical history, physical and laboratory examinations.
3.Subjects with Sexual Desire Inventory (SDI) Scale score 45 or lower indicating low sexual desire/ low libido.
4.Subjects willing to sign an informed consent document.
5.Subjects willing to adhere to protocol requirements throughout the study period.
6.Subjects who have not participated in any clinical study in the past 30 days. 
 
ExclusionCriteria 
Details  1.Subjects with known clinically significant cardiovascular, neurological, respiratory, gastrointestinal, genitourinary, congenital or any other disorder as determined by the investigator that may interfere with the study outcome or put the subjects in medical risk.
2.Subjects with any other sexual disorders like Erectile Dysfunction (ED), Pre-Mature Ejaculation (PME) or subjects taking any other medications like vasodilators, PDE-5 inhibitors, prostaglandins, or any other herbal or dietary supplement for sexual wellness within past one month.
3.Subject with any other significant cause of low libido like social, personal, or cultural which in the opinion of the investigator may interfere with the study results.
4.Subjects with known history or present condition of allergic response to the study drug or any ingredients in the investigational product.
5.Pre-existing systemic diseases (auto immune disorders, hormonal replacement, etc.) necessitating long-term medications.
6.Male subjects who refrain to use adequate contraception and donate sperm from first admission to the study until 90 days after the follow-up visit.
7.Known alcohol or any other substance abuse according to DSM-V criteria
8.Any other reason (physical, psychological, or social) that can interfere with the subject’s compliance to the study in the opinion of the Investigator. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Efficacy Endpoints
•Number of subjects showing improvement and/or improvement in mean Sexual Desire Inventory (SDI) scale score from baseline (day1) to EOS (day28).
•Number of subjects showing improvement and/or mean improvement in each symptom of Aging Male Symptoms Scale (AMS) score from baseline to EOS. 		 Day 1 And Day 28 
 
Secondary Outcome  
Outcome  TimePoints 
Safety Endpoints
•General Physical Examinations & Vital Signs.
•Laboratory Examinations. (Appendix-1)
•Incidence of adverse events during the study period.
•Proportion of subjects withdrawing from trial because of adverse events (tolerability). 		 Day1 & Day28 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   20/05/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
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
Modification(s)  

Study Title: An Open-Label, Single Arm Clinical Study to Evaluate the Safety, Efficacy and Tolerability of HSLG-032303 in Healthy Adult Males with Low Libido.

Protocol Number: HWC/MSCD/PP/009/2024

Version Number: 1.1, Dated: 28th Jun 2024

This is an Interventional clinical study. The study is designed to evaluate safety & efficacy of the investigational product HSLG-032303.

The study will last for 4 weeks per subject, with the aim to screen a sufficient number of subjects to obtain at least 40 evaluable subjects. The study population consists of adult male subjects aged between 21-50 years, as defined by the study’s inclusion/exclusion criteria.

This is a Single Arm Study, meaning all participants receive the same intervention. The study involves 3 visits: a screening visit within 7 days prior to baseline, a baseline visit on Day 1, and an end-of-study visit on Day 28 (with a +2 days window period).

Subjects who meet the eligibility criteria will be enrolled into the study after signing the informed consent. They will be given the investigational product on Day 1 and advised to take it for a period of 28 days.

The study’s efficacy will be measured by the number of subjects showing improvement and/or mean improvement in the Sexual Desire Inventory (SDI) scale and each symptom of the Aging Male Symptoms Scale (AMS) from baseline to the end of the study.

Safety will be assessed through general physical examinations & vital signs, laboratory examinations, and monitoring the incidence of adverse events during the study period. The proportion of subjects withdrawing from the trial due to adverse events will also be noted as a measure of the product’s tolerability.

 


 
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