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CTRI Number  CTRI/2025/10/096246 [Registered on: 21/10/2025] Trial Registered Prospectively
Last Modified On: 17/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Management of Lingam Sathilya through Brihat Shatavri Modak 
Scientific Title of Study   CLINICAL EVALUATION OF THE EFFECT OF BRIHAT SHATAVRI MODAK IN LINGAM SHATHILYA (ERECTILE DYSFUNCTION) 
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 Anupam Sheoran  
Designation  MD SCHOLAR  
Affiliation  Uttaranchal Ayurvedic college, Dehradun  
Address  17, Old Mussoorie Rd Kairwaan Gaon, Dehradun, Uttarakhand 248009 Department of Ayurved Samhita and Siddhant Dehradun Uttaranchal 248009 India
17, Old Mussoorie Rd Kairwaan Gaon, Dehradun, Uttarakhand 248009 Department of Ayurved Samhita and Siddhant Dehradun Uttaranchal 248009 India
Dehradun
UTTARANCHAL
248009
India 
Phone  8820000081  
Fax  248009  
Email  Anupamsheoran92@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Imran Mehtab Patel  
Designation  PROFESSOR & HOD 
Affiliation  Uttaranchal Ayurvedic college, Dehradun  
Address  17, Old Mussoorie Rd Kairwaan Gaon, Dehradun, Uttarakhand 248009 Department of Ayurved Samhita and Siddhant Dehradun Uttaranchal 248009 India
17, Old Mussoorie Rd Kairwaan Gaon, Dehradun, Uttarakhand 248009 Department of Ayurved Samhita and Siddhant Dehradun Uttaranchal 248009 India
Dehradun
UTTARANCHAL
248009
India 
Phone  9370106316  
Fax  248009  
Email  drimranpatel@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Imran Mehtab Patel  
Designation  PROFESSOR & HOD 
Affiliation  Uttaranchal Ayurvedic college, Dehradun  
Address  17, Old Mussoorie Rd Kairwaan Gaon, Dehradun, Uttarakhand 248009 Department of Ayurved Samhita and Siddhant Dehradun Uttaranchal 248009 India
17, Old Mussoorie Rd Kairwaan Gaon, Dehradun, Uttarakhand 248009 Department of Ayurved Samhita and Siddhant Dehradun Uttaranchal 248009 India
Dehradun
UTTARANCHAL
248009
India 
Phone  9370106316  
Fax  248009  
Email  drimranpatel@gmail.com  
 
Source of Monetary or Material Support  
PG DEPARTMENT OF AYURVED SAMHITA AND SIDDHANT, UTTARANCHAL AYURVEDIC COLLEGE, DEHRADUN 248009 INDIA  
 
Primary Sponsor  
Name  UTTARANCHAL AYURVEDIC COLLEGE, DEHRADUN  
Address  17, Old Mussoorie Rd Kairwaan Gaon, Dehradun, Uttarakhand 248009 Department of Ayurved Samhita and Siddhant Dehradun Uttaranchal 248009 India  
Type of Sponsor  Other [Private Ayurveda college Hospital ] 
 
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 Anupam Sheoran   Department of Ayurved Samhita and Siddhant   17, Old Mussoorie Rd Kairwaan Gaon, Dehradun, Uttarakhand 248009 Department of Ayurved Samhita and Siddhant Dehradun Uttaranchal 248009 India
Dehradun
UTTARANCHAL 		 8820000081
248009
Anupamsheoran92@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee Uttaranchal Ayurvedic college   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N528||Other male erectile dysfunction. Ayurveda Condition: LINGANASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Brihat Shatavri Modak , Reference: Bhaisajya Ratnavali, Route: Oral, Dosage Form: Modaka , Dose: 12(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -luke warm water), Additional Information: -no
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  50.00 Year(s)
Gender  Male 
Details  Patient of male age between 30 to 50 years. 
 
ExclusionCriteria 
Details  Patient below 30 & above 50 year of age.
Patient on steroids.
Alcoholic sand/or drug abusers.
Patient suffering from major systemic illness DM/HTN/CANCER/HIV etc.
H/o hypersensitivity to any of the trial drug or their ingredients. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in sign & symptoms   Reduction in sign & symptoms  
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in objective assessment criteria of Lingam Sathilya   3months 
 
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 3/ Phase 4 
Date of First Enrollment (India)   13/11/2025 
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="0"
Months="3"
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   An interventional study will be done on Number of Patient 30 with administration of Brihat Shatavri Modak for Forty five days. The patients will be assessed on basis of subjective and objective criteria of Lingam Sathilya before and after trial. Follow up will be taken on every 15th day. 
The data will be collected and analyzed statistically using appropriate test.
 
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