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CTRI Number  CTRI/2023/03/050315 [Registered on: 03/03/2023] Trial Registered Prospectively
Last Modified On: 09/07/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda
Nutraceutical 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To Evaluate Efficacy of TESNOR Supplementation on Libido, Sexual Function 
Scientific Title of Study   Efficacy of TESNOR Supplementation on Libido, Sexual Function and Symptoms of Testosterone Decline in Aging Males. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
LN/SF/LN18178/22 Version 01 Dated 03-Dec-2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Manoj Kumar Srivastava 
Designation  Principle Investigator 
Affiliation  Kashi Medicare 
Address  M-28, Room No 2, Department of General Medicine, Ground Floor, Ashok Vihar Colony Phase 1, Pandeypur, Paharia,

Varanasi
UTTAR PRADESH
221001
India 
Phone  9415256272  
Fax    
Email  manojsrivastava39@yahoo.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Golakoti Trimurthulu 
Designation  Senior Vice President Technical 
Affiliation  Laila Nutraceuticals 
Address  Laila Nutraceuticals Room No 13 Ground Floor R&D Block Survey No 181 by 2 JRD Tata Industrial Estate Kanuru Vijayawada

Krishna
ANDHRA PRADESH
520007
India 
Phone  08666636666  
Fax  08662546216  
Email  drgt@lailanutra.in  
 
Details of Contact Person
Public Query  
Name  Alluri Venkatakrishna Raju 
Designation  General Manager 
Affiliation  Laila Nutraceuticals 
Address  Laila Nutraceuticals Room No 17 Ground Floor R&D Block Survey No 181 by 2 JRD Tata Industrial Estate Kanuru Vijayawada

Krishna
ANDHRA PRADESH
520007
India 
Phone  08666636666  
Fax  08662546216  
Email  avkr@lailanutra.in  
 
Source of Monetary or Material Support  
Laila Nutraceuticals R&D Block Surevy No 181 by 2 JRD Tata Industrial Estate Kanuru Vijayawada Krishna District ANDHRA PRADESH 520007 India 
 
Primary Sponsor  
Name  Laila Nutraceuticals 
Address  40-15-14, Brindavan Colony, Labbipet Vijayawada-520 010 Andhra Pradesh India 
Type of Sponsor  Other [Nutraceuticals Industry] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manoj Kumar Srivastava  Kashi Medicare  M-28, Room no 2, Ground Floor Ashok Vihar Colony Phase 1, Ashok Vihar Colony, Pandeypur, Paharia
Varanasi
UTTAR PRADESH 		 9415256272

manojsrivastava39@yahoo.in 
Dr Gaurav Singh  Upendra Medicare  Department of General Medicine S4/50, Mahaveer Mandir, Chauraha, Ardali Bazar Rd,
Varanasi
UTTAR PRADESH 		 9555112643

drgauravsingh371@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Vatsalya Ethics committee for Kashi Medicare  Approved 
Vatsalya Ethics committee for Upendra Medicare  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  sexual function 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugOther than Classical(1) Medicine Name: Placebo, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 400(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 84 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: one capsule (400 mg) daily morning after the breakfast for 84 days administered orally
2Intervention ArmDrugOther than Classical(1) Medicine Name: LN18178, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 400(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 84 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: one capsule (400 mg) daily morning after the breakfast for 84 days administered orally
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Male 
Details  1. Healthy males aged between 40-70 years with a Body Mass Index (BMI) of 20-29 kg/m2.
2. Male subjects with Erectile function domain of IIEF score between 17 and 25. Sexual desire domain (Q.11 and Q.12) of IIEF score of <3 each.
3. Subject agrees to not use supplements including vitamins and minerals or herbals for at least 15 days before screening visit, and for the duration of the study.
4. Subjects agreed to refrain from drinking coffee or caffeinated drinks or beverages 24 hrs before the evaluation days.
5. Subjects with total testosterone ≥300 ng/dL.
6. Subjects who are recreationally active.
7. Subjects who are in a stable sexual relationship and sexually active during the study.
8. Subjects agree to maintain current diet and activity level.
9. Subject considered generally healthy as per the investigator opinion from health history and routine clinical investigations.
10. Subjects willing to follow an approved birth control measure; if partner has childbearing potential.
11. Subject should provide written informed consent and agree to be available throughout the study duration for follow-ups.
12. Subject agrees not to start any new therapies for sexual health or energy boosting or protein or testosterone supplements or health drinks during the course of the study.
 
 
ExclusionCriteria 
Details  1. Subjects with blood pressure >140/90 mmHg, fasting plasma glucose >125 mg/dL and abnormal ECG.
2. Subjects underwent treatment for COVID 19 within last 3 months or tested positive during the study will be excluded.
3. Subject with any physical disability that may limit sexual function or erectile dysfunction.
4. 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.
5. Subjects with clinical history of genital surgery, endocrine disorders e.g. hypopituitarism, pituitary tumors, hypo- and hyperthyroidism, hypogonadism, inherited (genetic and chromosomal) disorders, etc.
6. Subjects diagnosed with sleep apnea or related disorders.
7. Subjects consuming medications that can interfere with muscle mass such as corticosteroids, testosterone replacement or anabolic drugs.
8. History of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
9. Subjects consuming alcohol (>3 standard drinks per week) or smokers (>3 cigarettes per day).
10. Subjects who consume recreational drugs (such as cocaine, methamphetamine, marijuana, etc.) or chewable tobacco products.
11. 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.
12. Subjects under medications including anti-hypertensives, antidepressants, anticholinergics, inhaled beta agonists, anti-hyperlipidemics, psychotropics etc.
13. 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.
14. Subjects who underwent major surgical procedures in last 6 months.
15. Subject with HIV positive or any other STDs.
16. Subject has participated in a clinical study within the last 30 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 
Derogatis interview for sexual functioning-Self Report-Male (DISF-SR-M)  Day 1, Day 14, Day 42 and Day 84 
 
Secondary Outcome  
Outcome  TimePoints 
Change from baseline to the end of the study period in International index of erectile function (IIEF)  Day 1, Day 14, Day 42 and Day 84 
Change from baseline to the end of the study period in Multidimensional fatigue inventory (MFI-20)  Day 1, Day 42 and Day 84 
Change from baseline to the end of the study period in Pittsburgh sleep quality index (PSQI)  Day 1, Day 42 and Day 84 
Change from baseline to the end of the study period in Six-minute walk test (6MWT)  Day 1, Day 14, Day 42 and Day 84 
Change from baseline to the end of the study period in General health survey (on libido, muscle mass, muscle strength, energy, stamina, and sleep)  Day 1, Day 14, Day 42 and Day 84 
Change from baseline to the end of the study period in Grip strength (using digital hand dynamometer)  Day 1, Day 14, Day 42 and Day 84 
Change from baseline to the end of the study period in Erection hardness score (EHS questionnaire)  Day 1, Day 14, Day 42 and Day 84 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   06/03/2023 
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="6"
Days="21" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   NIL 
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 TESNOR supplementation on libido, sexual function and symptoms of Testosterone decline in aging males. Enrolled subjects will receive either LN18178 or placebo. 
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