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CTRI Number  CTRI/2020/11/028782 [Registered on: 02/11/2020] Trial Registered Prospectively
Last Modified On: 30/08/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Efficacy and Safety Of Ayurvedic Formulation For Erectile Dysfunction and Premature Ejaculation  
Scientific Title of Study   An open label Single center Prospective Study to evaluate efficacy and safety of two Ayurvedic Combination(s) in treatment of co-existing Erectile Dysfunction and Premature Ejaculation 
Trial Acronym  CT-AKJ-01- 2020 
Secondary IDs if Any  
Secondary ID  Identifier 
CT-AKJ-01- 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sankalp Jain 
Designation  Principal Investigator 
Affiliation  Consultant 
Address  Gautam Buddha Marg, Opposite Mohan Hotel & SBI ATM, Cash and Pay Colony, Charbagh, Lucknow, Uttar Pradesh

Lucknow
UTTAR PRADESH
226004
India 
Phone  7827758840  
Fax    
Email  drsankalpkrjain@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Devesh Kumar 
Designation  Director Clinical Trial Operations 
Affiliation  IR Innovate Research Pvt. Ltd 
Address  Office Number B 1 Building D 13 Sector 3 Noida 201301

Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  7827758840  
Fax    
Email  Devesh.kumar@innovate-research.com  
 
Details of Contact Person
Public Query  
Name  Dr Devesh Kumar 
Designation  Director Clinical Trial Operations 
Affiliation  IR Innovate Research Pvt. Ltd 
Address  Office Number B 1 Building D 13 Sector 3 Noida 201301

Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  7827758840  
Fax    
Email  Devesh.kumar@innovate-research.com  
 
Source of Monetary or Material Support  
Dr Ak Jain Clinic Gautam Buddha Marg, Opposite Mohan Hotel & SBI ATM, Cash and Pay Colony, Charbagh, Lucknow, Uttar Pradesh 226004  
 
Primary Sponsor  
Name  DrSankalp Jain  
Address  Dr. AK Jain Clinic Gautam Buddha Marg Opposite Mohan Hotel and SBI ATM Cash and Pay Colony Charbagh Lucknow 226004 UP India 
Type of Sponsor  Other [Self] 
 
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 
DrSankalp Jai   Dr. AK Jain Clinic  Gautam Buddha Marg Opposite Mohan Hotel and SBI ATM Cash and Pay Colony Charbagh Lucknow 226004 UP India
Gautam Buddha Nagar
UTTAR PRADESH 		 9935199999

drsankalpkrjain@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IndependentEthics Committe Of Narayana Diagnostics  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:R37||Sexual dysfunction, unspecified. Ayurveda Condition: Erectile Dysfunction ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Capsule -1  1-1 Red PF Capsule every Morning & every Evening for 30 Days 
Intervention  Capsule -2  1 VC Capsule every Night for 30 Days 
Comparator Agent  NA  NA 
Intervention  NT oil  NT Oil topical application on penis once at night. Total quality 10 ml 
Intervention  Powder  1 Tea Spoon (Each Day) for 30 Days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  64.00 Year(s)
Gender  Male 
Details  Male subjects between 18 to 64 years of age.
2. Male subjects with stable, monogamous, heterosexual relationship for
at least 6 months and expected/planned to maintain this relationship
for duration of study.
3. Subjects meeting with diagnostic criteria for erectile dysfunction (as
per the international index of erectile function (IIEF) score lesser than
or equal to 25; as specified in Urology 1999, 54: 346-351).
4. Subjects meeting with diagnostic criteria for premature ejaculation
(PE score greater than or equal to 11) as specified in article published
in European Urology 2007, 52: 565-573.
5. Subject and his partner agreeing to attempt sexual intercourse 2
times/ week.
6. Subject willing to give written informed consent and willing to comply
with trial protocol. 
 
ExclusionCriteria 
Details  1. Previous events or other conditions associated with premature
ejaculation/erectile dysfunction including but not limited to spinal
trauma or pelvic surgery.
2. Subjects with genital anatomical deformities including but not limited
to penile deformities.
3. Subjects with erectile dysfunction or premature ejaculation due
medication withdrawal.
4. Sexual dysfunction in female partner, painful intercourse, partners
with decreased interest in intercourse or other forms of sexual
dysfunction.
5. Subjects with major psychiatric illness or previous suicidal attempts.
6. Subjects with history of epilepsy
7. Subjects with history of stroke, myocardial infraction, heart failure,
unstable angina, life-threatening arrhythmia and hypotension with in
past 6 months.
8. Subjects for whom sexual activity is inadvisable because of their
underlying disease status.
9. Subject is a known case of autonomic neuropathy, retinitis
pigmentosa, bleeding disorders, sickle cell anemia and active peptic
ulcer disease.
10. Subjects with significant and uncontrolled hematological/metabolic/
endocrinologial/respiratory/cardiovascular/neurological/psychiatric
/liver/kidney diseases.
11. Subjects with resting hypotension (BP 90/50) or hypertension ( BP
170/110)
Proprietary and confidential informat 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The safety and tolerability of the investigational product will be
Proprietary and confidential information Page 8 of 29
assessed by the Clinical AEs, including laboratory abnormalities
Assessment Intervals Day 1 Day 35 		 Day 1, Day 35 
 
Secondary Outcome  
Outcome  TimePoints 
 Improvement Sperm concentration per milliliter of seminal fluid
 Improvement Proportion of Sperm motility
 Improvement Proportion of Sperm morphology
 		 Day 1, Day 35 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/11/2020 
Date of Study Completion (India) 15/03/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="15" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   To be published once study is completed 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

It is a Investigator initiate clinical study which involves the collection of clinical data to evaluate the safety and effectiveness of Ayurvedic Combination(s) in treatment of co-existing Erectile Dysfunction & Premature Ejaculation.


 
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