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CTRI Number  CTRI/2024/07/070801 [Registered on: 18/07/2024] Trial Registered Prospectively
Last Modified On: 16/07/2024
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 Narasimha Churna in Ksheena Shukra (Oligospermia)  
Scientific Title of Study   A Comparative Clinical Study To Evaluate The Effect Of Narasimha Churna And Gokshuradi Churna In The Management Of Ksheena Shukra W.S.R. to Oligospermia 
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 Ronaksinh Kher 
Designation  P G Scholar 
Affiliation  Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre 
Address  OPD Department Of Kayachikitsa Ground Floor SDM Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre Dr Siddhant Nagar, Terdal 587315

Bagalkot
KARNATAKA
587315
India 
Phone  9998546400  
Fax    
Email  Ronak.kher18@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sukumar Nandigoudar 
Designation  Professor 
Affiliation  Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre 
Address  OPD Department Of Kayachikitsa Ground Floor SDM Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre Dr Siddhant Nagar, Terdal 587315

Bagalkot
KARNATAKA
587315
India 
Phone  9986125625  
Fax    
Email  vaidyasukumar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ronaksinh Kher 
Designation  P G Scholar 
Affiliation  Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre 
Address  OPD Department Of Kayachikitsa Ground Floor SDM Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre Dr Siddhant Nagar, Terdal 587315

Bagalkot
KARNATAKA
587315
India 
Phone  9998546400  
Fax    
Email  Ronak.kher18@gmail.com  
 
Source of Monetary or Material Support  
SDM Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre Dr Siddhant Nagar, Terdal 587315 Bagalkot karnataka 
 
Primary Sponsor  
Name  Dr Ronaksinh kher 
Address  SDM Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre Dr Siddhant Nagar, Terdal 587315 Karnataka 
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 Ronaksinh Kher  Padma Ayurvedic Hospital And Research Centre  OPD Department Of Kayachikitsa Ground Floor Padma Ayurvedic Hospital And Research Centre Terdal 587315
Bagalkot
KARNATAKA 		 9998546400

Ronak.kher18@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SDMTs Ayurvedic Medical College And Padma Ayurvedic Hospital Institutional 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: SUKRAKSHAYAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Narasimha Churna, Reference: Bhaishajya Ratnavali Vajikarana Prakarana, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Go dugdha), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Gokshuradi Churna, Reference: Bhaishajya Ratnavali Vajikarana Prakarana, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Go dugha), Additional Information: -
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  50.00 Year(s)
Gender  Male 
Details  1.Patients presenting with Pratyatma Lakshana (Daurbalya, Shukra Avisarga, Medra Vrushanavedana, Maithuna ashakti Mukhasosha Panduta, Sadana, Shrama, Klaibya) of Ksheena sukra.
2.Diagnosed cases of Oligospermia.(Sperm count less than 15 million/ml)
3.Male patient with the age 21 to 50 years.
4.Patient with abnormal sperm motility will also be included in the study.
5.Subjects willing to sign consent will be included.  
 
ExclusionCriteria 
Details  1.Diagnosed cases of varicocele, accessory sex
gland infection, sexually transmitted diseases,
benign prostatic hyperplasia.
2.Diagnosed cases of azoospermia and aspermia.
3.Diagnosed cases of genetic defects like
Klinefelter syndrome and mosaic variants.
4.Diagnosed cases of major systemic illnesses and
sexual dysfunction due to anatomical, surgical
or pharmacological causes.
5.K/C/O uncontrolled hypertension, uncontrolled
diabetes and taking treatment for psychiatric
illness. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Effect Of Trial Drug On Improvements In The Symptoms Of Ksheena Shukra (Oligospermia)  15day, 31day, 60day 
 
Secondary Outcome  
Outcome  TimePoints 
Safety Of Trial Drug And Adverse Drug Reaction And Aggravation Of Symptoms Of Ksheenashukra (Oligospermia)  15day, 31day, 60day 
 
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)   29/07/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 is a major health problem across the world. One of the main reasons for male infertility is extreme low sperm count which affect the ability to conceive. Oligospermia is a condition wherein sperm count is less than 15 million/ml and is multifactorial in origin, such as unhealthy lifestyle, lack of physical activity, high pressure jobs, poor diet, alcoholism, smoking and tobacco chewing.
  • In India nearly 50% of infertility is related to the reproductive anomalies or disorders in the male of which 90% are related to oligospermia.
  • Oligospermia can be correlated with Ksheena Shukra. In Ksheena Shukra Vata and Pitta Dosha undergo vitiation and disturb the normal physiology of Shukra Dhatu. Vrushya Chikitsa like Dhatu Upachaya (Shukra Janana) is beneficial. The Vrushya/Rasayana Dravyas having properties like Madhura, Tikta, Snigdha & Guru should be administered.
  • Hence Narasimha Churna mentioned in Bhaishajya Ratanavali is selected as trial drug and compare its effect with Gokshuradi Churna in the management of Ksheena shukra (Oligospermia) The study is a Randomised controlled clinical trial. 40 patients of Oligospermia will be selected incidentally and randomly assigned into two groups; Group ‘A’ and ‘B’ by software generated chart. Group A patients will be given Narasimha Churna and Group B will be Gokshuradi Churna respectively.
  • Total Study duration will be 60 days and contain 4 visits (0th day, 15th day,31st day, 60th day.), which includes administration of trial drug for 30 days and post medication follow up on 60th day. After study, data will be collected from case report form (CRF) and statistically analysed by using appropriate parametric and non-parametric tests and results will be obtained. On that basis results, conclusion will be drawn.
 
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