| CTRI Number |
CTRI/2015/01/005374 [Registered on: 07/01/2015] Trial Registered Prospectively |
| Last Modified On: |
03/10/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to evaluate Efficacy and Safety of LI80020F4 in improvement of Muscular Energy, Endurance, and Muscle Strength |
|
Scientific Title of Study
|
Evaluation of Efficacy and Safety of a Novel herbal composition LI80020F4 in improvement of Muscular Energy, Endurance and Muscle Strength in Resistance trained Healthy Male Subjects: A Randomized, Double-Blind, and Placebo-Controlled Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prason Kumar |
| Designation |
Assistant Manager.Clinical Development |
| Affiliation |
Laila Nutraceuticals |
| Address |
Laila Nutraceuticals Brindavan colony Labbipet VIJAYAWADA Krishna ANDHRA PRADESH 520010 Krishna ANDHRA PRADESH 520010 India
Krishna
ANDHRA PRADESH
520010
India |
| Phone |
08666636666 |
| Fax |
08662546216 |
| Email |
prason@lailanutra.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Golakoti Trimurtulu |
| Designation |
Vicepresident RnD |
| Affiliation |
Laila Nutraceuticals |
| Address |
Laila RnD Centre Unit I Phase 3 Jawahar Autonagar Vijayawada Krishna ANDHRA PRADESH 520007 India Krishna ANDHRA PRADESH 520007 India
Krishna
ANDHRA PRADESH
520007
India |
| Phone |
08666636666 |
| Fax |
08662546216 |
| Email |
drgt@lailanutra.in |
|
Details of Contact Person
Public Query
|
| Name |
Prason Kumar |
| Designation |
Assistant Manager.Clinical Development |
| Affiliation |
Laila Nutraceuticals |
| Address |
Laila Nutraceuticals Brindavan colony Labbipet VIJAYAWADA Krishna ANDHRA PRADESH 520010 Krishna ANDHRA PRADESH 520010 India
Krishna
ANDHRA PRADESH
520010
India |
| Phone |
08666636666 |
| Fax |
08662546216 |
| Email |
prason@lailanutra.in |
|
|
Source of Monetary or Material Support
|
| Laila Nutraceuticals internal funding |
|
|
Primary Sponsor
|
| Name |
Laila Nutraceuticals |
| Address |
Laila Nutraceuticals 40 15 14 Brindavan Colony Labbipet Vijayawada |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr K Manikyeswara Rao |
Suraksha Health Village |
Suraksha Health Village, 121, SBH complex, Gurunanak Nagar Road, Vijayawada-520008 Andhra Pradesh, India.
Krishna
ANDHRA PRADESH
Krishna
ANDHRA PRADESH |
9866377188
surakshahealthvillage@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| ASR Institutional Ethics Committee |
Approved |
| ASR Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Muscle Energy , Endurance and Muscle strength |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LI80020F4 400mg |
2 capsule to be taken every morning before breakfast for 42 days |
| Comparator Agent |
Placebo |
2 capsule to be taken every morning before breakfast for 42 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Male |
| Details |
Male subjects between 18-40 years of age
Ability to understand the risks/benefits of the protocol
Subjects familiar with weight training and have at least 6 months experience training, 4 times per week for at least 3 to 4hours. (Recreational athletes)
Agree to do physical activities as stated in the protocol in presence of physical trainer
Willingness to participate in an exercise program (4 days a week, during the course of the study)
Subjects should be available for duration of study period (7weeks)
Subject agrees not to start any new supplement which would affect body composition during the course of the study
Subjects agree to maintain the activity dairy
Willing to give written informed consent and willing to comply with trial protocol
|
|
| ExclusionCriteria |
| Details |
No contraindications to exercise as outlined by the American College of Sports Medicine (ACSM).
Use of nutritional supplements known to improve energy and muscle strength and/or muscle mass (e.g., Creatine, HMB, androstenedione, DHEA, etc.) within seven weeks prior to the start of the study.
All medications that can interfere with muscle mass such as corticosteroids (e.g. Prednisone), testosterone replacement or anabolic drugs.
Subjects who are under herbal supplements within seven (7) days prior to screening.
Subjects using any other therapies that would affect body composition other than those revealed during recruitment process.
Subjects having history of asthma.
Subjects having history of cardiovascular diseases.
Subjects having history of diabetes (Type I or Type II) except other than the subject having the pre-diabetes condition with the fasting blood glucose between 100 to 125 mg/dl or random blood glucose ≥ 140-199 mg/dl.
Subjects having thyroid disease.
Subjects having abnormal liver or kidney function tests (ALT or AST 2 times the upper limit of normal; elevated Creatinine, males 125 µmol/L,).
Subjects having abnormal findings on complete blood count
Subjects with HIV Positive.
Subjects having history of high alcohol intake (2 standard drinks per day).
Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
Any other condition that, in the opinion of the investigator, would adversely affect the subjects ability to complete the study or its measures.
Subjects participated in any clinical study within thirty (30) days prior to screening.
|
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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 the baseline to the end of the supplement period in
Muscle strength
(It will be measured by 1-RM in bench Press and leg Press) and
Muscular Endurance
(It will be measured by total number of repetitions and weight lifted via leg extensions)
|
Day 7, 21,35 and 49
|
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Change from the baseline to the end of the supplement period in :
• Time to Exhaust in Treadmill (Day-7, Day 21, Day 35, and Day-49).
• Measurement in Arm circumference (muscle size), Body-composition analysis by DEXA (Day-7 and Day-49),
• Change in Serum biomarker like IGF-1, IGFBP-3, Free Testosterone, Insulin and Lactate. Lactate will be assessed before the starting of treadmill exercise (pre-exercise) and after achieving the exhaust time (post exercise) at baseline and Day-49.
|
Day 7 and 49
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/01/2015 |
| Date of Study Completion (India) |
Date Missing |
| 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
|
|
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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 improvement of Muscular Energy, Endurance, and Muscle Strength as measured by 1 repetition maximum (1-RM) of LI80020F4 versus placebo in resistance trained Healthy Male Subjects. Enrolled subjects will receive either LI80020F4 or a placebo for 6 weeks.
40 males of age 18 - 40 years, resistance trained healthy subjects will be enrolled into the study through Screening Criteria for 49 days. Assessment of blood and urine will be carried out at screening and final visit. Assessment of serum biomarkers shall be carried out during the randomization and final study visit. The study is to be carried out at one center, to recruit 40 subjects to assess the study specific objective to evaluate efficacy of LI80020F4 in improving Muscular energy, Endurance and Muscle Strength.
To evaluate the safety and tolerability of the LI80020F4 by monitoring the vital signs and possibility of adverse events at each follow-up visits
|