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CTRI Number  CTRI/2025/07/091586 [Registered on: 24/07/2025] Trial Registered Prospectively
Last Modified On: 31/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Single Arm Study 
Public Title of Study   Benefits of Shilajeet in improving sperm count in men with low fertility  
Scientific Title of Study   Clinical Evaluation of the Effect of Meet Shilajeet-K on Spermatogenic Activity in Men with Oligospermia: An Open Label Study 
Trial Acronym  Nil 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
TG/PRO/25/NUT/001; Version no: 2.0 Date:02SEP2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Shruthi Rao  
Designation  Senior Project Manager 
Affiliation  TrialGuna Private Limited 
Address  467, 1st Main, 4th Cross, Royal County Layout, JP Nagar, 8th Phase, 2nd Block, Bangalore, Karnataka-560083, India

Bangalore
KARNATAKA
560083
India 
Phone  9686575019  
Fax    
Email  shruthi.rao@trialguna.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Shruthi Rao  
Designation  Senior Project Manager 
Affiliation  TrialGuna Private Limited 
Address  467, 1st Main, 4th Cross, Royal County Layout, JP Nagar, 8th Phase, 2nd Block, Bangalore,Karnataka-560083,India

Bangalore
KARNATAKA
560083
India 
Phone  9686575019  
Fax    
Email  shruthi.rao@trialguna.com  
 
Details of Contact Person
Public Query  
Name  Meena Dalal 
Designation  CEO and Founder  
Affiliation  TrialGuna Private Limited 
Address  467, 1st Main, 4th Cross, Royal County Layout, JP Nagar, 8th Phase, 2nd Block, Bangalore,Karnataka-560083,India

Bangalore
KARNATAKA
560083
India 
Phone  9972636265  
Fax    
Email  meena@trialguna.com  
 
Source of Monetary or Material Support  
NIl 
 
Primary Sponsor  
Name  Herbal Creations 
Address  (A Unit of Kumaon Exports Pvt. Ltd.) Village- Nayagaon, Chandansingh, Block-Kotabagh, PO Kamola, Nainital, Uttarakhand-263139, India 
Type of Sponsor  Other [Nutraceutical Industry-Indian] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Altapahusen   Citizen Hospital   Citizen Hospital, #14, 2nd Main, Dispensary Rd, Kalasipalya, Bangalore - 560002.
Bangalore
KARNATAKA 		 9980107723
-
vivatiqcr@gmail.com  
Dr Sucharitha L  Pandit Clinic   No.193, Department of Panchakarma, Room No.6, 1st Floor, 5th Main, Chamrajpet, Bangalore, Karnataka-560018.
Bangalore
KARNATAKA 		 9448863073
-
sucharitha.pandit@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
CItizen Hospital Institutional Ethics Committee, Citizen Wellness LLP  Approved 
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: N461||Oligospermia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Meet Shilajeet-K  1. Fulvic acid 2. Levodopa  
 
Inclusion Criteria
Modification(s)  
Age From  25.00 Year(s)
Age To  45.00 Year(s)
Gender  Male 
Details  Participants eligible for inclusion in the study must meet the following criteria:
1)Adult males aged 25 to 45 years.
2)Diagnosed with oligospermia (sperm concentration less than 20 million ml) in the semen sample collected during the screening period with or without progressive sperm motility of less than 30 percent and less than 4 percent of sperm with normal morphology.
3)Willing and able to provide semen samples during the screening and at end of study, following 2 to 7 days of sexual abstinence for each sample.
4)Willing to use acceptable contraception during the study period of 90 days.
5)No use of any spermatogenic enhancing drugs like hormonal medications, investigational reproductive drugs, prescription fertility treatments in the past 3 months.
6)Consumed any nutraceuticals, over the counter supplements or herbal remedies to manage oligospermic condition within 30 days prior to screening and baseline visit.
7)No history of chronic systemic diseases (e.g. diabetes, hypertension, hyperlipidemia, thyroid disorders).
8)Subjects should be available for duration of study period (90 days).
9)Willing and able to comply with study procedures including scheduled visits, dosing regimen, semen collections, and safety assessments.
10)Provided written informed consent voluntarily before any study related procedure.
11)Subjects willing to refrain from smoking and drinking for the duration of the study. 
 
ExclusionCriteria 
Details  The study will exclude individuals meeting any of the following criteria:
1) History of infertility due to non-oligospermic causes (e.g., obstructive azoospermia, genetic disorders).
2) Individuals with azoospermia or necrospermia/ necrozoospermia.
3) Chronic use of medications affecting spermatogenesis (e.g., anabolic steroids, chemotherapy).
4) Clinically significant medical conditions, including but not limited to cardiovascular, neurological, psychiatric, renal, hepatic, immunological, endocrine (such as uncontrolled diabetes or thyroid disease), or haematological abnormalities.
5) Individuals with a history of mumps, measles, smallpox, chicken pox, tuberculosis or injury to genitalia in the preceding 10 years.
6) Known hypersensitivity or allergy to Shilajit or its components.
7) Participation in any other clinical trial within the last 3 months.
8) Current heavy smokers (Greater 20 cigarettes/day) or participants with ongoing hazardous alcohol consumption (Greater 14 standard drinks/week).
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change from the baseline (Semen analysis results from screening visit) to the end of the supplement period (Day 90) in
1) Change in sperm concentration from the baseline to the end of the supplement period.
2) Change in total sperm count from the baseline to the end of the supplement period.
3) Change in total sperm motility from the baseline to the end of the supplement period. 		 Day 0 and Day 90 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
Any change from the baseline to the end of the supplement period Day 90 in:
1) Semen parameters:
a. Semen volume mL
b. Appearance, color, liquefaction time, & viscosity
c. pH (qualitative)
2)Sperm morphology:
a.Percentage of normal & abnormal forms (head, neck, tail)
b.Sperm vitality (Percent)
3. Cellular elements in semen:
a.Pus cells, epithelial cells, red blood cells, trichomonads, & Candida
4)Agglutination & clumping of sperm
5)Vital signs- blood pressure, pulse rate, heart rate, respiratory rate, body temperature from baseline to the end of the study-Time points: Day 0, Day 30, Day 60 & Day 90.
6)Liver & kidney function parameters from baseline to the end of the study- Time points: Day 0 & Day 90.
7)Occurrence of the treatment-related adverse events during study period. 		 Day 0
Day 30
Day 60
Day 90 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   13/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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   It aims to evaluate the effect of Meet Shilajeet-K supplementation (500 mg daily for 90 days) on spermatogenic activity, semen quality, and hormonal profiles in adult males diagnosed with oligospermia. The primary objective is to assess changes in sperm concentration, total sperm count, and total motility over a 3-month period. Secondary objectives include evaluating additional semen parameters such as volume, liquefaction time, viscosity, pH, and fructose levels, as well as assessing changes in sperm morphology (normal and abnormal forms) and sperm vitality. The study will also monitor the safety and tolerability of Meet Shilajeet-K through liver and renal function tests. This trial seeks to provide scientific evidence for the potential role of Meet Shilajeet-K as a non-invasive treatment option for men with oligospermia. 
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