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CTRI Number  CTRI/2024/12/077785 [Registered on: 06/12/2024] Trial Registered Prospectively
Last Modified On: 03/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect Of Shree Gopal Taila in Premature Ejaculation  
Scientific Title of Study   Evaluating Add On Effect Of Shree Gopal Taila In Shukragat Vata (Premature Ejaculation)- A Randomized Controlled Clinical Trial  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Arshad Mohammad  
Designation  PG Scholar 
Affiliation  KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya 
Address  Department of Kayachikitsa-Rasayana Evam Vajikarana, KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka,INDIA

Belgaum
KARNATAKA
590003
India 
Phone  9417656600  
Fax    
Email  arshadmohd729@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Suhas Kumar Shetty  
Designation  Professor and Principal Department of Kayachikitsa  
Affiliation  KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya 
Address  Department of Kayachikitsa-Rasayana Evam Vajikarana, KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka INDIA

Belgaum
KARNATAKA
590003
India 
Phone  9449603234  
Fax    
Email  drsuhasshetty@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Suhas Kumar Shetty  
Designation  Professor and Principal Department of Kayachikitsa  
Affiliation  KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya 
Address  Department of Kayachikitsa-Rasayana Evam Vajikarana, KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka INDIA

Belgaum
KARNATAKA
590003
India 
Phone  9449603234  
Fax    
Email  drsuhasshetty@gmail.com  
 
Source of Monetary or Material Support  
KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka 590003 
 
Primary Sponsor  
Name  Dr Arshad Mohammad  
Address  Department of Kayachikitsa-Rasayana Evam Vajikarana, KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka 590003 
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 
Dr Arshad Mohammad   KAHERs KLE Ayurveda Hospital And Medical Research Centre,Belgavi,Karnatka,590003   OPD NO.21 of KLE Ayurveda Hospital and MRC KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka 590003
Belgaum
KARNATAKA 		 9417656600

arshadmohd729@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Research on Human Subjects KAHERs Shri B.M.Kankanwadi Ayurveda Mahavidyalaya and KLE Ayurveda Hospital, Shahapur, Belagavi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N531||Ejaculatory dysfunction. Ayurveda Condition: SUKRAGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: jatiphala chooran, Reference: sharangadhara samhita poorva khand, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -milk), Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: jatiphala chooran, Reference: sharangadhara samhita poorva khand, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: - milk), Additional Information: -
3Intervention ArmProcedure-aBya~ggaH, अभ्यंग (Procedure Reference: bhaishajya ratnavali ,vatvyadirogadhikar, Procedure details: Take a sufficient amount of oil Apply oil to your hands Apply oil overall to Penis if person is going for intercourse then Keep it minimum for 3-5 minutes and after that Clean genitalia with a soft towel. if person is not going for intercourse then Keep it for overnight. )
(1) Medicine Name: shree gopal taila, Reference: bhaishjaya ratnavali vatvayadi rogaadhikar, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: hs, Duration: 45 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Male 
Details  Subjects with IELT less than 1 minute
Subjects with PEDT score more than 11
Subjects within the age group of 20 to 50 years
Subjects either married or unmarried (sexually active) 
 
ExclusionCriteria 
Details  Subjects with Diagnosed case of Peyronie’s Disease, paraphimosis, Epispadias, Hypospadias.

Subjects with uncontrolled autoimmune disorders, metabolic disorders, longstanding infections or any psychiatric illness.

Diagnosed cases of Erectile Dysfunction.

Subjects with recurrent UTI and recent history of Orchitis, Trauma and Acute
febrile illness 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Premature Ejaculation Diagnostic Tool(PEDT)
2.Intravaginal Ejaculatory Latency Time (IELT)

 		 1.PEDT on Base Line,15Day,30Day,45Day ,60Day
2.IELT on Base Line 
 
Secondary Outcome  
Outcome  TimePoints 
Ayurvedic Symptoms Such As Aharshanam (Lack Of Desire),Kshipram munchati (Premature Ejaculation),Apraharsh (Lack Of Orgasam),Maithunottar Shrama (Post– Act Exhaustion),Maithune Svasakrucchrata (Difficulity in Breathing During/After Sex),Maithune Prasvedanam (Perspiration During / After Sex)
 		 On Base Line,15th Day,30th Day,45th Day, 60th Day 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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/ Phase 3 
Date of First Enrollment (India)   01/01/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   In present era, sexual dysfunctions are a major cause of concern, due to sedentary life style, food habits, socio-cultural changes. Sexual dysfunction has become a reason for sexual conflict & problems among married couple. In all sexual dysfunction most common disorder is premature ejaculation with prevalence rate of 30%-55% (worldwide). PREMATURE EJACULATION: Acc. To Master and Johnson Premature Ejaculation (PE) is inability to control ejaculation for a sufficient length of time during intravaginal containment to satisfy female partner in at least 50% of coital events.[1] The current treatment modalities for premature ejaculation are limited and provide only temporary effect. In Ayurveda PREMATURE EJACULATION is corelated with SHUKRAGAT VATA Acharya Charka, in vata Vyadhi chikitsa explained kshiprammunchyath as one of the lakshana of shukragata vata. which means the person will have early ejaculation during sexual intercouse.[6] In the present Study oral administration of JATIPHAL CHOORNA[3] along with SHREE GOPAL TAILA for (L/A) Is selected for the managment of PE. JATIPHALA CHOORNA which having Shukra Stambhana property is selected for oral administration and SHREE GOPAL TAILAM as local application which is mentioned in Ayurvedic text and which is act as aphrodisiac.  
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