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CTRI Number  CTRI/2017/08/009195 [Registered on: 01/08/2017] Trial Registered Prospectively
Last Modified On: 20/07/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To study the efficacy and safety of Nagavalyadi churna in the management of Premature ejaculation 
Scientific Title of Study   Randomized double blind parallel arm placebo controlled study to evaluate the effect of Nagavallyadi Churna on IELT, patient reported outcome and safety in men with Premature ejaculation 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Venkatesha S 
Designation  Reader 
Affiliation  JSS Ayurveda Medical College and Hospital 
Address  Dept of PG studies in Roganidana room no 11 JSS Ayurveda Medical College and Hospital Lalithadiripura road Mysore

Mysore
KARNATAKA
570028
India 
Phone  08212548360  
Fax  08212548361  
Email  drvenkys75@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Venkatesha S 
Designation  Reader 
Affiliation  JSS Ayurveda Medical College and Hospital 
Address  Dept of PG studies in Roganidana room no 11 JSS Ayurveda Medical College and Hospital Lalithadiripura road Mysore 570028

Mysore
KARNATAKA
570028
India 
Phone  08212548360  
Fax  08212548361  
Email  drvenkys75@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Venkatesha S 
Designation  Reader 
Affiliation  JSS Ayurveda Medical College and Hospital 
Address  Dept of PG studies in Roganidana room no 11 JSS Ayurveda Medical College and Hospital Lalithadiripura road Mysore

Mysore
KARNATAKA
570028
India 
Phone  08212548360  
Fax  08212548361  
Email  drvenkys75@gmail.com  
 
Source of Monetary or Material Support  
JSS Ayurveda Medical College and Hospital Mysore  
 
Primary Sponsor  
Name  Rajiv Gandhi University of Health Sciences 
Address  Rajiv Gandhi University of Health Sciences, Karnataka 4th T Block, Jayanagar Bangalore 560 041  
Type of Sponsor  Other [Health University ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Venkatesha S  JSS Ayurveda Medical College and Hospital, Mysore  Room No. 11 Specialty OPD
Mysore
KARNATAKA 		 9844210154
08212548361
drvenkys75@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Premature ejaculation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nagavallyadi churna  Nagavalli, Bala, Jati, Jatiphala, Paribhadra, Apamarga, Ashwagandha, kankola, Ushira, Yastimadhu and Vacha  
Comparator Agent  Placebo   Starch 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Male 
Details  1. Male subjects aged ≥18 years
2. Subject has to provided written informed consent(Annexure-4 )
3. Subjects must be in a stable, monogamous, sexual relationship with the same partner for at least 6 months and plan to maintain this relationship for the duration of the trial.
4. Subjects with the same sexual orientation and partner gender Preference.
5. Acceptance to attempt intercourse on a regular basis and at least once a week.
6. Non-pregnant partners.
7. Subjects must be in good general health with no clinically relevant abnormalities, normal blood chemistry, testosterone, CBC, urinalysis, and 12-lead ECG
8. Subjects must meet criteria for diagnosis of PE using a multivariate definition of PE and a baseline trial specific threshold ejaculatory latency time, e.g., intravaginal ejaculatory latency time (IELT).
9. Subjects must meet criteria for diagnosis of PE with a PEDT score ≥11 indicates
 
 
ExclusionCriteria 
Details  1. Use of any investigational drug within the past month or within a period of five times the drug half-life, if it is longer.
2. Any significant somatic disorder.
3. Any potential neurologic, urologic, or endocrine cause of PE.
4. Any current or previous psychiatric disorder.
5. Current or previous alcohol or psychoactive substance abuse or dependence.
6. Use of any medication that could cause sexual dysfunction.
7. Any other sexual dysfunction including ED.
8. Untreated hypogonadism, hyperprolactinemia, or hyper- or hypothyroidism.
9. Clinically significant sexual dysfunction of the partner.
10. Subject with hypoactive sexual desire, retrograde, delayed or absent orgasm or ejaculation or ED (IIEF-5 >21) (Annexure -1)
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
the efficacy of Nagvalyadi Churna with respect to duration of IELT
safety and tolerability
change in IPE  		 safety and tolerability
change in IPE will be assessed in every week of treatment phase
 
 
Secondary Outcome  
Outcome  TimePoints 
safety and tolerability
change in IPE 		 safety and tolerability and change in IPE will be assessed in every week of treatment phase
 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   15/01/2018 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

      This is a Randomized double blind parallel arm placebo controlled study to evaluate the efficacy, safety of Nagavallyadi Churna on both life long and acquired premature ejaculation. This well controlled PE RCT methodology includes Placebo control. The Nagavllyadi churna is being evaluated for the first time in a placebo controlled trial, the number of subjects that must be enrolled is relatively small and consequently the number of non-responders is also small.

Initially in screening phase it is also treatment free phase subjects will be screened for inclusion criteria and randomization will be done. In treatment phase subjects will be allocated for treatment by double blinding method with a follow of four visits. In the post-trial phase subjects will be interrogated for residual adverse effect and data will be collected, the collected data will be analysed and assessment will be done by using appropriate stastical methods.  
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