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CTRI Number  CTRI/2025/07/090017 [Registered on: 02/07/2025] Trial Registered Prospectively
Last Modified On: 30/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Ayurveda treatment in low sperm count. 
Scientific Title of Study   An open label randomized controlled clinical study to evaluate the combined effect of Virechana and Shamananga Sneha with Amrithaprasha Ghrita in the management of Ksheena Shukra vis-a-vis Oligozoospermia. 
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 Thejesh H B 
Designation  Post Graduate Scholar  
Affiliation  JSS Ayurveda Medical College and Hospital 
Address  JSS Ayurveda Medical College and Hospital Kayachikitsa OPD No. 1 41/E Lalithadripura Road Alanahalli Mysore Mysore KARNATAKA 570028 India

Mysore
KARNATAKA
570028
India 
Phone  8951265075  
Fax    
Email  thejeshdevaru@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Beena M D 
Designation  Professor  
Affiliation  JSS Ayurveda Medical College and Hospital 
Address  JSS Ayurveda Medical College and Hospital Kayachikitsa OPD No. 1 41/E Lalithadripura Road Alanahalli Mysore Mysore KARNATAKA 570028 India

Mysore
KARNATAKA
570028
India 
Phone  9538367282  
Fax    
Email  drpbsreddy@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Thejesh H B 
Designation  Post Graduate Scholar  
Affiliation  JSS Ayurveda Medical College and Hospital 
Address  JSS Ayurveda Medical College and Hospital Kayachikitsa OPD No. 1 41/E Lalithadripura Road Alanahalli Mysore Mysore KARNATAKA 570028 India

Mysore
KARNATAKA
570028
India 
Phone  8951265075  
Fax    
Email  thejeshdevaru@gmail.com  
 
Source of Monetary or Material Support  
#41/E, JSS Ayurveda Medical College and Hospital, Lalitadripura Road, Alanahalli, Mysore, Karnataka, India - 570028 
 
Primary Sponsor  
Name  Self 
Address  Room No. 01, Department of Kayachikitsa, JSS Ayurveda Medical College and Hospital, #41/E Lalithadripura, Mysore,570028, Karnataka, 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 
Dr Thejesh H B  JSS Ayurveda Medical College and Hospital  JSS Ayurveda Medical College and Hospital Kayachikitsa OPD No. 1 41/E Lalithadripura Road Alanahalli Mysore Mysore KARNATAKA 570028 India
Mysore
KARNATAKA 
8951265075

thejeshdevaru@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethical Committee  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: BIJOPAGHATAJAKLAIBYAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Standard care for OligozoospermiaGroup B Subjects diagnosed as Oligozoospermia with Standard of care will be observed for 30 days.
2Intervention ArmDrugClassical(1) Medicine Name: Amrithaprasha Grhita, Reference: API, Route: Oral, Dosage Form: Ghrita, Dose: 12(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  50.00 Year(s)
Gender  Male 
Details  Subjects who are married between the age group of 21-50 years irrespective of socio-economic status.
Subjects who fulfill the diagnostic criteria.
Subjects who are willing to provide informed consent after explaining the ingredients of the Amrithaprasha Ghrita for the study.
Subjects fit for Virechana Karma.
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the Combined Effect of Virechana and Shamananga Sneha in the management of Ksheena shukra Vis-à-vis Oligozoospermia.  before treatment - 0th day
after treatment - 43rd to 55th day 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the efficacy of standard of care and ayurvedic management in Oligozoospermia.  before treatment - 0th day
after treatment - 43rd to 55th day 
 
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 3 
Date of First Enrollment (India)   15/07/2025 
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 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  

       Male infertility can be defined as an inability to induce conception, due to defect in spermatozoic functions like low sperm count, unhealthy sperm production, low sperm motility and altered delivery of sperms due to altered physiology of male reproductive system. Infertility is one of the major issues of concern among couples worldwide. Approximately 40-50% male infertility cases are reported in India, out of which sperm parameters are the main reason for 2% of cases. Oligozoospermia refers specifically to a condition in which sperm concentration below the lower reference limit of 15 million sperm/mL of ejaculate. The standard of care is antioxidants, vitamin supplements, clomiphene citrate, which increases the production of FSH and LH hormones which increases the testosterone production leading to increase in the sperm count. In Ayurveda we have scattered references of ksheena shukra mentioned under asta shukra dusti. Ksheena shukra is vata and pitta dosha pradhana. It is characterized by both qualitative and quantitative reduction in shukra dhatu. Shukra is one of the sapta dhatus. Shukra is the final dhatu that is created from the prasada bhaga (essence) of the majja dhatu and is also thought to be the essence of all the dhatus. Virechana is Vata anulomaka and Pitta rechaka, hence indicated in ksheena shukra caused due to vitiation of vata and pitta dosha. As quoted in Ayurveda classics, Ghrita is having shukra vardhaka property, hence shamananga snehana with Amritaprasha ghrita is chosen. Amritaprasha Ghrita is indicated in nashtashukra, durbala and streeprasakta rogi and has brimhana effect.

 
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