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CTRI Number  CTRI/2024/10/076053 [Registered on: 29/10/2024] Trial Registered Prospectively
Last Modified On: 24/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Ayurvedic Management of Ksheena Sukra w s r to Oligopsermia 
Scientific Title of Study   A Clinical Study of Efficacy of Virechana with Trivritadi Lehyam followed by Purna chandra ras orally in the management of Ksheena sukra w s r to Oligopsermia 
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 Sravankumar choppara 
Designation  Post Graduate in Kayachikitsa 
Affiliation  Dr BRKR Government Ayurvedic Medical college and Hospital 
Address  DR BRKR Government Ayurvedic Medical College Department of Kaya Chikitsa Devision 3 OP R.NO 3 near ESI metro station AG colony HYDERABAD
DR BRKR Government Ayurvedic Medical College Department of Kaya Chikitsa Devision 3 OP R.NO 3 near ESI metro station AG colony HYDERABAD
Hyderabad
TELANGANA
500038
India 
Phone  9492672035  
Fax    
Email  sraonekumarchoppara@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Swaroopa 
Designation  Professor MD Ayurveda Department of Kaya chikitsa 
Affiliation  Dr BRKR Government Ayurvedic Medical College and Hospital 
Address  Near ESI Metro Station AG colony HYDERABAD

Hyderabad
TELANGANA
500038
India 
Phone  9866275613  
Fax    
Email  swaroopa.kusuma95@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Swaroopa 
Designation  Professor MD Ayurveda Department of Kaya chikitsa 
Affiliation  Dr BRKR Government Ayurvedic Medical College and Hospital 
Address  Near ESI Metro Station AG colony HYDERABAD

Hyderabad
TELANGANA
500038
India 
Phone  9866275613  
Fax    
Email  swaroopa.kusuma95@gmail.com  
 
Source of Monetary or Material Support  
Dr BRKR Government Ayurvedic Medical College and Hospital AG colony Near ESI Metro Station Hyderabad 500038 
 
Primary Sponsor  
Name  Dr Sravankumar choppara 
Address  Dr BRKR Government Ayurvedic Medical College and Hospital AG colony Near ESI Metro Station Hyderabad 500038 
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 sravankumar choppara  Dr BRKR Government Ayurvedic Medical College and Hospital  DR BRKR Government Ayurvedic Medical College Department of Kaya Chikitsa Devision 3 OP R.NO 3 near ESI metro station AG colony HYDERABAD
Hyderabad
TELANGANA 		 9492672035

sraonekumarchoppara@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committe of Dr.B.R.K.R Government Ayurvedic college and hospital.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N461||Oligospermia. Ayurveda Condition: SUKRAKSHAYAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: kashyapa samhitha siddi sthana 2/5, Procedure details: Dipana Pachana drug Chitrakadi vati is given for 3 Days Followed by Snehapana with Go Ghrita upto samayak snigdha lakshanas Followed by Sarvanga Abhyanga with Bala Ashwagandha taila & Baspa Sweda for 3 days Followed by Virechana with Trivritadi lehyam one day followed by Samsarjana for 7 days )
(1) Medicine Name: purna chandra ras , Reference: bhaisajya ratnavali vajikarana adhyaya 74/71, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 125(mg), Frequency: bd, Duration: 90 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Male 
Details  Patients with clinical symptoms of Medra Vrishana vedana Alpa Sukratha mMithuna anashakti Chiradu praseka
controlled diabetes hypertension and hypothyroidism
sperm count below 15million per ml semen
who willing to participate in study and agreed for consent sign 
 
ExclusionCriteria 
Details  Chronic diseases like cardio vascular disease chronic kidney disease
patients with varicocele hydrocele congenital disorders
patients with controlled diabetes hypertension hypothyroidism 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To increase the Sperm count
To increase the motility of Sperms
To increase the semen volume
To decrease the morphological abnormalities 		 90 days 
 
Secondary Outcome  
Outcome  TimePoints 
To improve sexual activity
To decrease the Testicular pain
To increase the duration of ejaculation
 		 90 days 
 
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   N/A 
Date of First Enrollment (India)   09/11/2024 
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 Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 Male infertility is the major problem in the 21st Century in males .Because of modern life style and food habits that influencing the fertility of the men .As per Ayurveda it was explained in sukra dhatu dusti which impairing the decrease of sukra dhatu .Because of decrease in sukra dhatu not only decreasing the sperm count  it also decrease the motility sperm volume and morphological abnormalities.it also decrease the desire for intercourse and decrease in duration of intercourse and pain in the testicles. Hence the thesis was taken to asses the efficacy of  Classical Virechana  by Trivritadi Lehyam followed by Purna Chandra Ras orally in the management of ksheena sukra w s r to oligospermia 
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