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CTRI Number  CTRI/2025/06/089465 [Registered on: 24/06/2025] Trial Registered Prospectively
Last Modified On: 07/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of herbal supplement on improving sperm virility  
Scientific Title of Study   A randomized, double-blind, placebo-controlled pilot study to evaluate the efficacy of LN18178 on improving sperm virility (Sperm motility, sperm concentration, and sperm morphology) 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
GNC/SV/LN18178/25 Version 01, Dated 25-Jan-2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mr Garga Machiraju  
Designation  Overall Trail Coordinator 
Affiliation  Laila Nutra Private Limited 
Address  40-15-14, Room No: 01, Department of PCU-R&D, First Floor, Brindavan colony, Labbipet, Vijayawada

Krishna
ANDHRA PRADESH
520010
India 
Phone  8331015019  
Fax    
Email  machiraju.gls@gmail.com   
 
Details of Contact Person
Scientific Query
 
Name  Mr Garga Machiraju  
Designation  Overall Trail Coordinator 
Affiliation  Laila Nutra Private Limited  
Address  40-15-14, Room No: 01, Department of PCU-R&D, First Floor, Brindavan colony, Labbipet, Vijayawada

Krishna
ANDHRA PRADESH
520010
India 
Phone  8331015019  
Fax    
Email  machiraju.gls@gmail.com   
 
Details of Contact Person
Public Query
 
Name  Ms SD Parveen 
Designation  Project Management Executive 
Affiliation  Laila Nutra Private Limited 
Address  40-15-14, Room No: 01, Department of project management, First Floor, Brindavan colony, Labbipet, Vijayawada

Krishna
ANDHRA PRADESH
520010
India 
Phone  8331015073  
Fax    
Email  sparveen.gls@gmail.com   
 
Source of Monetary or Material Support  
Gencor Lifestage Solutions, 7801 N Lamar Blvd, Suite E210, Austin, Texas 78752, United States  
 
Primary Sponsor  
Name  Gencor Lifestage Solutions 
Address  7801 N Lamar Blvd, Suite E210, Austin, Texas 78752, United States 
Type of Sponsor  Other [Herbal Product Importer & Distributor] 
 
Details of Secondary Sponsor  
Name  Address 
Laila Nutra Private Limited  FIRST FLOOR, 40-15-14, SUDARSAN APARTMENT, BRINDAVAN colony, PO Area, COLONY, LABBIPET, VIJAYAWADA, KRISHNA, ANDHRA PRADESH - 520007, India. 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sowmya Davuluri  Akkineni Fertility Center   Room No: 02, Fourth Floor, IVF Department, Akkineni Women’s Hospital, D. No. 54-20/10-12, Srinagar Colony, Bharati Nagar Service Road, Vijayawada – 520008, India.
Krishna
ANDHRA PRADESH 
0866-2956668

ctuakkineniwhospital@gmail.com 
Dr Akurati Nilima  ZIVA Embryology and Fertility Institute, Branch at - Renova Neelima Hospital  First floor, B-Block, Opp Voltas Company, Sanath Nagar, Hyderabad-500018, India.
Hyderabad
TELANGANA 
09100002737

paleruneelima74@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee - Neelima Hospitals for Dr. Akurati Nilima  Approved 
Institutional Ethics Committee-NUHA Hospitals for Dr. Sowmya Davuluri  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Sperm Virility 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  LN18178  400 mg, One capsule to be consumed in the morning after breakfast for 12 Weeks. 
Comparator Agent  Placebo  One capsule to be consumed in the morning after breakfast for 12 Weeks 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  45.00 Year(s)
Gender  Male 
Details  1.Males aged between 25-45 years with a Body Mass Index (BMI) of 20-29 kg/m2.
2.Subjects with a history of infertility of at least 12 months despite regular unprotected intercourse.
3.Subjects with semen analysis showing abnormal sperm concentration (less than 16 million/ml), progressive motility (less than 30%), and total motility (less than 42%), normal morphology (less than 4%). (WHO guidelines- 6th edition, 2021)
4.Subjects with total testosterone greater than or equal to 300 ng/dL.
5.Subjects who are willing to abstain from sexual activity that results in ejaculation for 3 to 5 days before semen analysis.
6.Subjects who are in a stable sexual relationship and sexually active during the study.
7.Subjects willing to use contraceptives during study period.
8.Subjects agree to maintain current diet and activity level.
9.No urogenital infection or anatomical abnormality of this system, including varicocele; no prior history of surgery in the pelvic area; no uncontrolled systemic illness, such as liver and gallbladder cancers, renal failure, thyroid disorders, and cerebral haemorrhage; no prior history of trauma to the testes; no unilateral testicular atrophy; no previous history of chemotherapy or treatment with anticoagulants, corticosteroids, testosterone and anti-androgen medications during the 8 weeks before the study.
10.Subject considered generally healthy as per health history and routine clinical investigations during screening.
11.Ability to understand the risks/benefits of the protocol and willing to sign the written informed consent.
 
 
ExclusionCriteria 
Details  1.Employees working on night shifts.
2.Subjects with identifiable cause for Oligoasthenoteratozoospermia (OAT) (includes Cryptorchidism, Orchitis and Radiation or chemotherapy etc.).
3.Subjects with Systolic greater than 140 and Diastolic greater than 90 mmHg blood pressure and Fasting blood glucose (FBG) greater than 125 mg/dl.
4.Smokers and alcoholics.
5.Subjects underwent treatment for COVID 19 within the last 3 months or tested positive during the study will be excluded.
6.Subject with any physical disability that may limit sexual function.
7.Subjects with history of taking medications for oligospermia or any other sexual problems, including PDE-5 inhibitors, and dysfunctions related to genito-urinary system, muscular dystrophy and coagulation.
8.Subjects with clinical history of genital surgery, endocrine disorders e.g. hypopituitarism, pituitary tumors, hypo- and hyperthyroidism, hypogonadism, inherited (genetic and chromosomal) disorders, etc.
9.Subjects diagnosed with sleep apnea or related disorders.
10.Subjects consuming medications that can interfere with muscle mass such as corticosteroids, testosterone replacement or anabolic drugs.
11.Subjects who consume recreational drugs (such as cocaine, methamphetamine, marijuana, etc.) or chewable tobacco products.
12.Subjects having history of Benign Prostate Hyperplasia (BPH), stroke, myocardial infarction, coronary artery disease, cardiac failure, angina, life-threatening arrhythmia within the past 6 months.
13.Subjects under medications including vitamins, antidepressants, anticholinergics, inhaled beta agonists, anti-hyperlipidemics, psychotropics etc.
14.Subjects using any centrally acting anorectic agents, drugs that inhibit the absorption of nutrients and endocannabinoid neuromodulators during the two weeks prior to enrolment into the study.
15.Subjects who underwent major surgical procedures in last 6 months, which may affect their quality of life.
16.Subject with HIV positive or any other STDs.
17.History of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
18.Subject has participated in a clinical study within the last 90 days prior to recruitment or concurrently participating in another study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Change from baseline to the end of the study period in :
Sperm motility (%)  
Screening, weeks 8, 12 & 16 
 
Secondary Outcome  
Outcome  TimePoints 
Change from baseline to the end of the study period in :
Semen analysis (concentration and morphology of sperm) 
Screening, weeks 8, 12 & 16 
Sperm DNA fragmentation Index  Screening, Weeks 12 & 16  
International Index of Erectile Function (IIEF-15)  Baseline (day 1), Weeks 4, 8, 12 & 16 
Quality of life short form (SF-36)  Baseline (day 1), Weeks 4, 8, 12 & 16 
Serum hormonal biomarkers: total and free testosterone, LH, FSH and Inhibin B   Baseline (day 1), Weeks 12 & 16 
Semen oxidative stress markers (MDA, GSH and TAC)  Baseline (day 1), Weeks 12 & 16 
Semen inflammation markers (IL-6 and TNF-alpha)  Baseline (day 1), Weeks 12 & 16 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   N/A 
Date of First Enrollment (India)   30/06/2025 
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="7"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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  
The purpose of this study is to evaluate the efficacy of LN18178 on improving sperm virility. A total of 40 Males aged between 25-45 years will be included in the study. Assessment of inclusion and exclusion criteria will be done based on clinical and laboratory investigations. The eligible subjects will be randomized as per the computer-generated randomization list. The subjects will be assigned to either LN18178 - 400 mg or placebo arms at 1:1 ratio. The subjects will be instructed to take one capsule daily in the morning after breakfast for 12 weeks.
A part from primary and secondary outcomes, the study will also record the vital signs and adverse events to evaluate the herbal composition safety and tolerability. The safety assessment of the LN18178 will also include routine laboratory investigations on blood, urine and clinical chemistry at screening and the final visit of the intervention.
 
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