FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/06/068483 [Registered on: 06/06/2024] Trial Registered Prospectively
Last Modified On: 30/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluation of Ayurvedic Interventions for Oligozoospermia: A Comparative Clinical Study 
Scientific Title of Study   A Randomized Comparative Clinical Trial to Evaluate the Efficacy of Saraswata Ghrita and Madhuyastyadi Churna followed by Koshtha Shuddhi with Haritakyadi Churna in the Management of Ksheena Shukra (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 Bharat Singh 
Designation  PG Scholar 
Affiliation  National Institute of Ayurveda Deemed to be University Jaipur 
Address  Department of Kayachikitsa National Institute of Ayurveda Deemed to be University Near Jorawar Singh Gate Amer Road Jaipur RAJASTHAN 302002 India

Jaipur
RAJASTHAN
302002
India 
Phone  6375441313  
Fax    
Email  bharatsingh9294@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Hari Mohan Lal Meena 
Designation  Professor 
Affiliation  National Institute of Ayurveda Deemed to be University Jaipur 
Address  Department of Kayachikitsa National Institute of Ayurveda Deemed to be University Near Jorawar Singh Gate Amer Road Jaipur RAJASTHAN 302002 India

Jaipur
RAJASTHAN
302002
India 
Phone  9461297017  
Fax    
Email  hari_mohan68@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Prof Dr Hari Mohan Lal Meena 
Designation  Professor 
Affiliation  National Institute of Ayurveda Deemed to be University Jaipur 
Address  Department of Kayachikitsa National Institute of Ayurveda Deemed to be University Near Jorawar Singh Gate Amer Road Jaipur RAJASTHAN 302002 India

Jaipur
RAJASTHAN
302002
India 
Phone  9461297017  
Fax    
Email  hari_mohan68@yahoo.co.in  
 
Source of Monetary or Material Support  
National Institute of Ayurveda, Jaipur 
 
Primary Sponsor  
Name  National Institute of Ayurveda Deemed to be University Jaipur 
Address  Near Jorawar Singh Gate Amer Road Jaipur 302002 Rajasthan India 
Type of Sponsor  Government medical college 
 
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 Bharat Singh  Hospital, National Institute of Ayurveda, Deemed to be University, Jaipur  OPD No 1, 18, 22, 25, Hospital, National Institute of Ayurveda, Deemed to be University, Near Jorawar Singh gate, Amer Road Jaipur Jaipur RAJASTHAN 302002 India Jaipur RAJASTHAN
Jaipur
RAJASTHAN 		 6375441313

bharatsingh9294@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, National Institute of ayurveda  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
1Comparator ArmDrugClassical(1) Medicine Name: Madhuyashtyadi Churna,, Reference: Bharat Bhaisajya Ratnakar volume 4/5505, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Milk), Additional Information: -Sahapana is Madhu, Sarpi Anupana is Milk
2Intervention ArmDrugClassical(1) Medicine Name: Saraswata Ghrita, Reference: Chakradutta- Rasayanadhikara, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: -
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  50.00 Year(s)
Gender  Male 
Details  1.Age: between 21– 50 years.
2.Patients of Sperm count less then 15 million/mL.
3.Patients having any sign and symptoms of
4.KsheenaShukra (Oligozoospermia). 
 
ExclusionCriteria 
Details  Patients with primary and secondary Azoospermia.
Patients with chronic diseases like Hypertension, COPD, DM, CAD, Renal failure and hepatic
dysfunction.
Patients having any sexually transmitted diseases or HIV.
Known case of male infertility due to mumps, orchitis, diseases like hydrocele, varicocele and
undescended testes.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in sperm count.  At baseline and 90th day 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in the Serum Testosterone, LH and FSH level.
Changes in sperm motility, volume, morphology.
Changes in subjective parameters.  		 At baseline and 90th 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)   04/09/2024 
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)  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  

Oligozoospermia is a condition where sperm count is below 15 million/mL. Some of the known responsible factors for male infertility are poor semen quality, genetical factors, testicular dysfunction and endocrine dysfunction. Vajikaran is an important treatment modality as per Ayurveda and proposed benefits are manifold including increased sexual capacity , improving health of future progeny as well as in treatment of any common sexual disorders like infertility , erectile dysfunction and premature ejaculation. Vajikaran or vrishya chikitsa is the one of the eight major speciality of the Ashtanga Ayurveda. Aim of this study is to evaluate and compare the efficacy of Saraswata Ghrita and Madhuyashtyadi Churna after Koshtha Shuddhi with Haritakyadi Churna in the management of ‘Ksheena Shukra’ (Oligozoospermia).Study is designed as an Interventional, Single Centred, Randomized Comparative Clinical trial. Subjects will be screened according to WHO diagnostic criteria for oligozoospermia and will be allocated randomly into two groups of 20 in each. The total duration of the study will be 90 days. Assessment will be based on Changes in sperm count, Serum Testosterone, LH and FSH level, sperm motility, volume, morphology and subjective parameters at baseline and end of the trial.

 
Close