| CTRI Number |
CTRI/2025/07/091586 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
29/08/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
Public Title of Study
Modification(s)
|
Study to Assess Whether Shilajeet K Improves Sperm Quality in Adult Men with Infertility |
Scientific Title of Study
Modification(s)
|
Clinical Evaluation of the Effect of Meet Shilajeet-K on Semen Quality and Spermatogenic Activity in Adult Males with Infertility: An Open-Label Study |
| Trial Acronym |
Nil |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| TG/PRO/25/NUT/001; Version no: 3.0 Date:09DEC2025 |
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
Modification(s)
|
| Herbal Creations
A Unit of Kumaon Exports Pvt. Ltd. Uttarakhand |
|
|
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
|
|
|
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
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N468||Other male infertility, |
|
|
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 |
1. Men diagnosed with abnormal semen parameters during the screening period, defined as any of the following: Sperm concentration less than 20 million per mL, and Progressive sperm motility less than 32 percent, and Normal sperm morphology less than 4 percent.
2. Willing and able to provide semen samples during the screening and at end of study following 2 to 4 days of sexual abstinence for each sample.
3. Consumed any nutraceuticals over the counter supplements or herbal remedies to manage semen abnormalities including oligospermia, asthenozoospermia, teratozoospermia or oligoasthenoteratozoospermia within 30 days prior to screening and baseline visit.
|
|
| 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
Modification(s)
|
| Outcome |
TimePoints |
1. Change in sperm concentration from baseline to end of supplementation.
2. Change in total sperm count from baseline to end of supplementation.
3. Change in sperm motility total, progressive, non-progressive, and immotile from baseline to end of supplementation.
4. Change in sperm morphology normal and abnormal forms from baseline to end of supplementation |
Day 0 and Day 90 |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
a. Pus cells, epithelial cells, red blood cells.
b. Agglutination or Aggregation |
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. |