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
|
|
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. |