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CTRI Number  CTRI/2025/07/092015 [Registered on: 30/07/2025] Trial Registered Prospectively
Last Modified On: 28/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Ayurvedic Treatment for Premature Ejaculation using Dhatryadi Ghrit Uttar Basti and Swayamguptadi Churn 
Scientific Title of Study   EVALUATION OF THE EFFECT OF DHATRYADI GHRIT UTTAR BASTI AND SWAYAMGUPTADI CHURN IN THE MANAGEMENT OF SHUKRAGAT VAT WITH SPECIAL REFERENCE TO PREMATURE EJACULATION 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Hansraj Namchuriya 
Designation  PG Scholar 
Affiliation  Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal (M.P.) 
Address  PG Department of Panchkarma, room no 111 Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal (M.P) 462007

Bhopal
MADHYA PRADESH
462007
India 
Phone  9340203176  
Fax    
Email  namchuriyar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Babita Dash 
Designation  associate Professor 
Affiliation  Pt. Khusilal Sharma Government Autonomous Ayurveda College and Institute Bhopal (M.P.) 
Address  PG Department of Panchkarma, room no 111 Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal (M.P) 462007
PG Department of Panchkarma, room no 111 Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal (M.P) 462007
Bhopal
MADHYA PRADESH
462007
India 
Phone  8109591573  
Fax    
Email  drmissdash@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Hansraj Namchuriya 
Designation  PG Scholar 
Affiliation  Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal (M.P.) 
Address  PG Department of Panchkarma, room no 111 Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal (M.P) 462007

Bhopal
MADHYA PRADESH
462007
India 
Phone  9340203176  
Fax    
Email  namchuriyar@gmail.com  
 
Source of Monetary or Material Support  
PG Department of Panchkarma Pt Khushilal Government Autonomous Ayurveda College and Institute Bhopal (M.P.) 
 
Primary Sponsor  
Name  Pt. Khushilal Sharma Government Autonomous Ayurveda College and Instititute Bhopal (M.P.)  
Address  PG Department of Panchkarma, Pt. Khusilal Sharma Government Autonomous Ayurveda College and Institute Bhopal (M.P) 462007 
Type of Sponsor  Government funding agency 
 
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 
Hansraj Namchuriya  Pt. Khushilal Sharma Ayurveda College and institute, Bhopal (M.P.)  PG Department of Panchkarma, room no. 111 Pt. Khushilal Sharma Government Autonomous Ayurveda college and Institute Science Hills Bhopal (M.P.) 462007
Bhopal
MADHYA PRADESH 		 09340203176

namchuriyar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC) Pt. Khusilal Sharma Government Ayurveda Institute Bhopal (M.P).  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F524||Premature ejaculation. Ayurveda Condition: SUKRAGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugOther than Classical(1) Medicine Name: Placebo , Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: sukhoshana jala), Additional Information: -
2Intervention ArmProcedure-uttara-bastiH, उत्तर-बस्तिः (Procedure Reference: Charak Samhita Siddhi Sthana 9, Procedure details: 20 patients of this group will be treated with Uttar Basti using Dhatryadi Ghrit- total 9 sittings, each involving the administration of 24 ml of Dhatryadi ghrit instilled into the urinary bladder using a sterile urethral catheter under aseptic conditions. The treatment schedule will follow a specific pattern: the first 3 sittings will be administered on 3 consecutive days, followed by a 3-day interval, the next 3 sittings will be administered over subsequent 3 consecutive days, followed by another 3-day interval, finally, the remaining 3 sittings will be administered over the last 3 consecutive days.)
(1) Medicine Name: Dhatryadi Ghrit, Reference: Sahastrayog, Kendriya Ayurveda Vigyan Anusandhan Parishad - Ghritam Adhyay Prakaran - Dhatryadi Ghrit, Ghrit yog no. 70, Reprint 2011, page no. 314 , Route: Urethral, Dosage Form: Ghrita, Dose: 24(ml), Frequency: od, Duration: 15 Days
3Intervention ArmDrugClassical(1) Medicine Name: Swayamguptadi Churn, Reference: Chakradatta. 4th ed. Varanasi: Chaukhamba Sanskrit Pratishthan; 2020. Vrishyaadhikara. p. 431., Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Sukhoshna jala), Additional Information: -
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  50.00 Year(s)
Gender  Male 
Details  Patient with the symptoms of Shukragat vat.
Patient of lifelong PE.
Patient of acquired PE.
Patients of 21 years to 50 years age irrespective of religion, socio-economic status, and occupation.
Patients who have given written consent to participate in the study. 
 
ExclusionCriteria 
Details  Patients having other systemic pathology like Tuberculosis, Renal failure, Diabetes Mellitus, Hypertension, severe urinary tract infections, Nephrolithiasis, Urethral stricture and Medico Renal Diseases (MRD) or malignancy of urogenital system.
Patients associated with other endocrine diseases.
Patients having any genital infection or any congenital deformity of urogenital tract.
Patients who are not willing to sign written consent to participate in study. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
It is expected that at the end of the study we would be able to demonstrate the effect of Dhatryadi Ghrit Uttar Basti and Swayamguptadi churn in the management of shukragat vat (premature ejaculation).   12 months 
 
Secondary Outcome  
Outcome  TimePoints 
It is further expected that this study would be able to provide conclusive inputs to assess the efficacy of the Ayurvedic management of Premature ejaculation.  11 months 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   25/12/2025 
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="0"
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   From this study, it is expected that at the end of the study we would be able to demonstrate the effect of Dhatryadi Ghrit Uttar Basti and Swayamguptadi Churn in the management of Shukragat Vat (premature ejaculation). It is further expected that this study would be able to provide conclusive inputs to assess the efficacy of the Ayurvedic management of Premature ejaculation. 
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