| CTRI Number |
CTRI/2018/11/016337 [Registered on: 15/11/2018] Trial Registered Prospectively |
| Last Modified On: |
18/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical study to assess effect of an herbal product in improving testosterone levels in healthy young males |
|
Scientific Title of Study
|
A randomized, double blind, placebo controlled clinical study to evaluate the efficacy and safety of a
novel herbal composition improving testosterone level in healthy young males |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LN/TB/YM/LN18178/18 Version 01 06-Aug-2018 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mr Prason Kumar |
| Designation |
Manager-Clinical Development |
| Affiliation |
Laila Nutraceuticals |
| Address |
Laila Nutraceuticals, 40-15-14,Brindavan colony,
Labbipet,VIJAYAWADA
Krishna
ANDHRA PRADESH
520010
India |
| Phone |
08666636666 |
| Fax |
08662546216 |
| Email |
prason@lailanutra.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Golakoti Trimurtulu |
| Designation |
Senior Vice-president R&D |
| Affiliation |
Laila Nutraceuticals |
| Address |
Laila R&D Centre, Unit I, Phase 3, Jawahar Autonagar Vijayawada
Krishna
ANDHRA PRADESH
520007
India |
| Phone |
08666636666 |
| Fax |
08662546216 |
| Email |
drgt@lailanutra.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr Prason Kumar |
| Designation |
Manager-Clinical Development |
| Affiliation |
Laila Nutraceuticals |
| Address |
Laila Nutraceuticals, 40-15-14,Brindavan colony,
Labbipet,VIJAYAWADA
Krishna
ANDHRA PRADESH
520010
India |
| Phone |
08666636666 |
| Fax |
08662546216 |
| Email |
prason@lailanutra.in |
|
|
Source of Monetary or Material Support
|
| Laila Nutraceuticals Internal funding
40-15-14, Brindavan colony,
Labbipet, Vijayawada
Krishna, Andhra Pradesh-
520010 |
|
|
Primary Sponsor
|
| Name |
Laila Nutraceuticals |
| Address |
Laila Nutraceuticals, 40-15-14 Brindavan Colony, Labbipet,
Vijayawada-520010,India. |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sreeramaneni Poorna Gopal Azad |
Anu Hospitals |
Room No.01, Ground Floor, Endocrinology,
Anu Hospitals,
Kovelamudivari Street,
Suryaraopet,
Vijayawada-520002
Krishna
ANDHRA PRADESH |
08662438881
08662434855
drpurnagopal@gmail.com |
| Dr K Manikyeswara Rao |
Suraksha Health Village |
Plot no.121, 3rd Floor, Suraksha Health
Village, SBI
Complex,Gurunanak
Nagar Road,
Vijayawada-520008
Krishna
ANDHRA PRADESH |
9866377188
drmanikyeswararao@gmail.com |
| Dr Amulya Yalamanchi |
Yalamanchi Hospitals and Research Centres Pvt. Ltd. |
Ground Floor, General Medicine, Yalamanchi Hospitals
and Research Centres
Pvt.Ltd. D.No.29-7-44,
Venkataratnam Street,
Suryaraopet,
Vijayawada-520002
Krishna
ANDHRA PRADESH |
08662431220
08662435988
amulya.yalamanchi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Alluri Sitaramaraju Ethics Committee for Dr. K. Manikyeswara Rao |
Approved |
| Institutional Ethics Committee-Anu Hospitals for Dr. Sreeramaneni Poorna Gopal Azad |
Approved |
| Yalamanchi Hospital Ethics Committee for Dr. Amulya Yalamanchi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy subjects |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LN18178 200 mg |
1 capsule to be taken daily in
the morning after breakfast for
56 days |
| Intervention |
LN18178 400 mg |
1 capsule to be taken daily in
the morning after breakfast for
56 days |
| Comparator Agent |
Placebo |
1 capsule to be taken daily in
the morning after breakfast for
56 days |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Male |
| Details |
Male subjects aged between 21 and 35 years with a Body Mass Index (BMI) between 20 and 29 kg/m2.
Willingness to do 40 min aerobic exercise per day (4 days a week)during the course of the study.
Subject considered generally healthy as per health history and routine clinical investigations.
Ability to understand the risks and benefits of the protocol.
Subject should provide written informed consent and agree to be available for regular follow up throughout the study duration.
Subjects agree to maintain the activity diary.
Subject agrees not to start any new therapies for sexual health or energy boosting supplements or protein supplements or health drinks during the course of the study.
Subjects willing to refrain from drinking coffee or caffeinated drinks or beverages during the study. |
|
| ExclusionCriteria |
| Details |
Subjects who are resistance trained or undergoing resistance training.
Subjects with history of taking medications for erectile dysfunction, oligospermia or any other sexual problems, urinary & prostate diseases and muscular dystrophy.
Subjects with clinical history of endocrine disorders e.g.hypopituitarism, pituitary tumors, hypo- and hyperthyroidism,hypogonadism, inherited(genetic and chromosomal) disorders, etc.
Subjects diagnosed with sleep apnea or related disorders.
Subjects consuming medications that can interfere with muscle mass such as corticosteroids, testosterone replacement or anabolic drugs.
History of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
Subjects consuming alcohol (>3 standard drinks per week) or smokers.
Subjects who consume recreational drugs (such as cocaine,methamphetamine, marijuana, etc.) or chewable tobacco products.
Subjects having history of Benign Prostate Hyperplasia (BPH),hypertension (BP>130/85 mmHg), diabetes (fasting plasma glucose>125 mg/dL), stroke, myocardial infarction, coronary artery disease,cardiac failure, angina, life-threatening arrhythmia within the past 6 months.
Subjects under medications including anti-hypertensives, inhaled beta agonists, anti-hyperlipidemics, psychotropics etc.
Use of 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.
Subjects who underwent major surgical procedures in last 6 months.
Subject with HIV positive or any other STDs.
Subject has illness as per the opinion of investigator.
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, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change from baseline to the end of the study
period in:
Serum testosterone |
Day 1,7, 14,28 and 56 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change from baseline to the end of the study
period in:
Estradiol
Luteinizing hormone (LH)
Dihydrotestosterone (DHT)
Cortisol
Grip strength
Mid-upper arm circumference (Arm girth) |
Estradiol and Luteinizing hormone (LH)at Day 1
and 56
Dihydrotestosterone(DHT),Cortisol,Grip strength
and Mid-upper arm circumference (Arm girth) at Day 1,7,14,28 and 56 |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
26/11/2018 |
| Date of Study Completion (India) |
25/03/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet decided. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The purpose of this study is to assess efficacy, safety and tolerability of an herbal composition LN18178 in improving testosterone level in healthy young males. A total of 120 healthy males of age between 21 and 35 years will be screened for eligibility criteria as per the study protocol. Assessment of inclusion and exclusion criteria will be done based on clinical and laboratory investigations. The eligible subjects will be randomized as per computer generated randomization list. Subjects will be assigned to either one of the three study groups (LN18178 200mg, LN18178 400mg or Placebo) and instructed to take the Investigational products for a period of 56 days. This study will measure serum hormones, grip strength, and mid upper arm circumferences of the participants, as the efficacy parameters. Besides, the study will also record the vital signs, and adverse events to estimate the herbal composition’s safety and tolerability. The safety assessment of the test product will also include the routine laboratory investigations on blood, urine and clinical chemistry parameters at screening and at the final visit of the intervention. |