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CTRI Number  CTRI/2024/07/071256 [Registered on: 25/07/2024] Trial Registered Prospectively
Last Modified On: 23/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Clinical Study to reduce premature ejaculation in healthy adult men  
Scientific Title of Study   A randomized, double blind, placebo-controlled, parallel arm clinical trial of De-Stress and Perform Capsule in the management of stress-induced premature ejaculation in healthy adult men 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MHC/CT/24-25/018 Ver. 1.00 Dated 25-June-2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ramshyam Agarwal 
Designation  Principal Investigator 
Affiliation  Lokmanya Medical Research Centre and Hospital 
Address  Room no 401 OPD Fourth floor 314 B Telco Road Chinchwad

Pune
MAHARASHTRA
411033
India 
Phone  8087282022  
Fax  -  
Email  ramshyam.research@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kriti Soni 
Designation  Global Head R and D 
Affiliation  Herbolab India Pvt. Ltd. 
Address  3rd Floor - A Wing, Marwah Centre, Krishanlal Marwah Marg, Marol, Andheri East

Mumbai
MAHARASHTRA
400072
India 
Phone  9871018383  
Fax  -  
Email  kriti.soni@rpsg.in  
 
Details of Contact Person
Public Query  
Name  Dr Kriti Soni 
Designation  Global Head R and D 
Affiliation  Herbolab India Pvt. Ltd. 
Address  3rd Floor - A Wing, Marwah Centre, Krishanlal Marwah Marg, Marol, Andheri East

Mumbai
MAHARASHTRA
400072
India 
Phone  9871018383  
Fax  -  
Email  kriti.soni@rpsg.in  
 
Source of Monetary or Material Support  
Herbolab India Pvt Ltd Floor - 6th, F-15 ,Plot 78, Commerce Centre, Pandit Madan Mohan, Malviya Marg, Tardeo, Mumbai, 400034 
 
Primary Sponsor  
Name  Herbolab India Pvt Ltd 
Address  3rd Floor - A Wing, Marwah Centre, Krishanlal Marwah Marg, Marol, Andheri East MUMBAI, MAHARASHTRA, 400072. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ramshyam Agarwal  Lokmanya Medical Research Centre and Hospital  Room no 401 OPD Fourth-floor 314 B Telco Road Chinchwad
Pune
MAHARASHTRA 		 8087282022
-
ramshyam.research@gmail.com 
Dr Dnyanraj Choudhary  Sangvi Multispeciality Hospital Pvt. Ltd.  Sr.No. 71/1/2/189 City Survey No.2387 Krushna Chowk, Krushna Nagar, New Sangvi
Pune
MAHARASHTRA 		 9823217423
-
drdnyanraj.sangvihospital@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee of Lokmanya Medical Research Centre  Approved 
Institutional Ethics Committee Sangvi Multispeciality Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  stress-induced premature ejaculation  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Destress and Perform Capsule-I001  Two Capsules in sequence daily after meal for 60 days. 
Intervention  Destress and Perform Capsule-U001  Two Capsules in sequence daily after meal for 60 days. 
Comparator Agent  Placebo capsules 002  Two Capsules in sequence daily after meal for 60 days. 
 
Inclusion Criteria
Modification(s)  
Age From  21.00 Year(s)
Age To  50.00 Year(s)
Gender  Male 
Details  1.Male participants aged 21-50 years both inclusive suffering from a. PE or b. ED 2.Suffering from self-reported mild to moderate stress on the PSS scale score less than or equal to 26 3.Participant having baseline IELT of less than 2 min 4.Participants meeting with diagnostic criteria for PEP score less than or equal to 11 5. Participants who have scored 11 to 25 on the Erectile Function EF domain of the International Index of Erectile Function IIEF at screening visit a subset of 15 patients only that is 5 participants from each group 6. Participants should be in an active stable sexual relationship only married participants for the entire duration of the study 7.Participants willing to participate in clinical trials and who have read understood and signed the informed consent form. 
 
ExclusionCriteria 
Details  1.Previous events or other severe conditions that may affect premature ejaculation/erectile dysfunction, including but not limited to spinal trauma or pelvic surgery
2.Participants with genital anatomical deformities, including but not limited to penile deformities
3.Participants for whom sexual activity is inadvisable because of their underlying disease status
4.Female partners experiencing sexual dysfunction, such as painful intercourse, low libido, or other forms of sexual dysfunction, as well as pregnant individuals
5.Presence or history of any of the following disorders/disease within the past 3 months, that might have impact on the clinical trial as per the investigator discretion. cardiovascular, b) cerebrovascular, c) dermatological, d) gastrointestinal, e) gynaecological, f) hematological, g) hepatic, h) malignancy, i) metabolic, j) musculoskeletal, k) neurological, l) psychiatric, m) thyroid n) psychological, o) renal, p) respiratory, q) venereal, r) any other major disorders
6.Participants that have undergone radical prostatectomy, spinal cord injury, or any other surgery of urogenital organs;
7.Participants with history or presence of significant alcoholism or drug abuse within the past 1 year
8.Participants with history or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco/nicotine products more than 10 times per day
9.Any concomitant treatment that is not permissible including but not limited to (nitrates, anti-androgens, chemotherapy agents, radiotherapy, etc).
10.Recent participation in another clinical trial or receiving some other drug during the study besides that in the protocol
11.Known hypersensitivity to any of the ingredients of investigational product
12.Participants concurrent use of sildenafil or other such drugs in the PDE5 inhibitor family, energy supplements, herbal or pharmaceutical aphrodisiacs, body composition enhancing agents, or other concurrent medication such as beta blockers, contraceptives, and psychotropic medications, nutraceutical, or ayurvedic supplement for stress and/or PE management
13.Other conditions, which in the opinion of the investigators, makes the participant unsuitable for enrolment or could interfere with his/her participation in, and completion of the protocol.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary outcomes are as follows- 1. Changes in perceived stress scale (PSS) score, PEP Score Questionnaire, sexual stamina using intravaginal ejaculatory latency time (IELT),libido system score (LSS), levels of serum testosterone, cortisol and LDH, weight and BMI, COPE Questionnaire (a. Positive Subscale b. Denial Subscale) score, cardiorespiratory endurance (maximal oxygen uptake VO2 max), % fat and % skeletal muscle using bioelectrical impedance analysis (BIA), handgrip strength using hand-held dynamometer.
2.Changes in blood flow assessed by penile doppler in ED participants, STAI (State-Trait Anxiety Inventory), Profile of Mood State (POMS) (a. Total Mood Disturbance b. Depression), cardiorespiratory endurance, Personal Assessment of Intimacy in Relationships (PAIR). 		 1.Screening, day 30 and day 60
2.Screening and day 60  
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcomes are as follows- 1.Assessment of adverse events, treatment compliance and tolerability of investigational products, vital sign parameters 2.Assessment of complete blood count, liver function test and kidney function test  1.Screening, baseline, day 30, day 60
2.Screening and day 60 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   Phase 2 
Date of First Enrollment (India)   06/08/2024 
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="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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 current study focuses on clinical validation of efficacy of nutraceutical product in management of male health. In healthy adult men with induced premature ejaculation, the introduction of these nutraceuticals has been associated with notable improvements in quality of life. These supplements help them for enhanced sexual satisfaction, increased control over ejaculation, and a reduction in performance anxiety. The psychological benefits are significant, as the improvement in sexual function can lead to higher self-confidence and a more positive outlook on life.

 
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