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CTRI Number  CTRI/2023/05/052358 [Registered on: 08/05/2023] Trial Registered Prospectively
Last Modified On: 28/04/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To observe the effect of cleansing procedure along with medicine in the treatment of low sperm count 
Scientific Title of Study   “A comparative clinical study to evaluate the efficacy of ardhamatrik basti and virechana karma followed by shamana ausadha in the management of kshina shukra w.s.r. to oligospermia” 
Trial Acronym  No 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kanji K Poriya 
Designation  PG SCHOLAR 
Affiliation  National institute of Ayurveda Jaipur 
Address  Room no 111 Department of Panchkarma National Institute of Ayurveda Deemed to be University Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  07405552385  
Fax    
Email  kanjiporiya95@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  dr vipin kumar 
Designation  Assistant Professor 
Affiliation  National institute of Ayurveda Jaipur 
Address  Room no 115 A Department of Panchkarma National Institute of Ayurveda Deemed to be University Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  8239889891  
Fax    
Email  vipintanwarpk@gmail.com  
 
Details of Contact Person
Public Query  
Name  dr vipin kumar 
Designation  Assistant Professor 
Affiliation  National institute of Ayurveda Jaipur 
Address  Room no 115 A Department of Panchkarma National Institute of Ayurveda Deemed to be University Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  8239889891  
Fax    
Email  vipintanwarpk@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda Deemed to be University Jaipur Rajasthan 
 
Primary Sponsor  
Name  National Institute of Ayurveda Deemed to be University Jaipur Rajasthan 
Address  Near Jorawar singh gate Amer Road Jaipur Rajasthan 
Type of Sponsor  Research institution and 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 Vipin Kumar  National Institute of Ayurveda Jaipur  OPD 2 Dpet of Panchkarma Near Jorawar singh gate amer road jaipur rajasthan 302002
Jaipur
RAJASTHAN 		 8239889891

vipintanwarpk@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committe  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 ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: chakradatta Niruaha basti adhikar 73/23-26, Procedure details: after completing abhyanga and swedan, kala basti should be administrated to the patient.)
(1) Medicine Name: Apatyakara ghrita, Reference: Charak Chikitsa 2(4)/28-29, Route: Oral, Dosage Form: Ghrita, Dose: 20(g), Frequency: od, Duration: 30 Days
2Intervention ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: Astang Hridaya Kalpa siddhi 2/9, Procedure details: After completing Snehan and Swedan, Virechan karma should be administrated with Trivruta Avaleha. )
(1) Medicine Name: Apatyakara ghrita, Reference: Charak Chikitsa 2(4)/ 28-29, Route: Oral, Dosage Form: Ghrita, Dose: 20(g), Frequency: od, Duration: 30 Days
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  50.00 Year(s)
Gender  Male 
Details  Patients having sperm count below 15 million per ml
Patient those are fit for basti karma and virechana karma 
 
ExclusionCriteria 
Details  Known case of various diseases like accesory sex gland infection, sexually transmitted diseases, sever systemetic disease and DM 2 uncontrolled HTN IJD malignancy genetic disorder
Taking treatmetn for major psychiatric problem
history of trauma leading to oligospermia 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The assessment will be done by semen analysis before and after treatment.
 		 8 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcome will be assessed by the scoring pattern prepared by Mehra and
Singh 1995 was adopted for the
assessment of the effect of therapies on sexual parameters.
 		 60 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   Phase 2/ Phase 3 
Date of First Enrollment (India)   02/10/2023 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   not published yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
   Recent statistical data shows nearly one among the six couple in the world are suffering from Infertility. Incidence of male infertility varies from 30-40%. Among these,24% Of the Male infertility is due to the factors like Oligospermia. Among these, 30% Of the Male infertility is due to the factors like Oligospermia, Asthenozoospermia, Azoospermia etc. Oligospermia is one among the prime factor in the male infertility.
       In conventional system, various drug like testosterone, clomiphene citrate, tamoxifen and HCG are used to increase sperm count, However these drugs are expensive and produces several adverse effects like gynecomastia, hepatic carcinoma, deep vein thrombosis, dyslipidemia.

                      In Ayurvedic system of medicine, Acharya has mentioned the different Type of drugs for ksheena shukra. Most of the Acharya has mentioned in the Vajikarana Adhyaya. Clinical studies from many ayurvedic institute reveal that ayurvedic drugs are potentially effective in oligospermia.
 
              Therefore, keeping all these facts in mind, it has been decided to conduct a clinical study entitled,“A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF ARDHAMATRIK BASTI AND VIRECHANA KARMA FOLLOWED BY SHAMANA AUSADHA IN THE MANAGEMENT OF KSHINA SHUKRA W.S.R. TO OLIGOSPERMIA”
Research Question-
Is there any difference between the  efficacy of   Ardhamatrik  Basti And Virechana Karma Followed By Shamana Ausadha in the management of Kshina Shukra With Special Reference to  Oligospermia?
Aim
To compare the efficacy of Ardhamatrik Basti and Virechana Karma followed by Shamana Ausadha in the management of Kshina Shukra (Oligospermia).
Objective-
To assess the efficacy of Ardhamatrik Basti followed by Shamana Ausadha in the management of Kshina Shukra (Oligospermia).
To assess the efficacy of Virechana Karma followed by Shamana Ausadha in the management of Kshina Shukra (Oligospermia).
To assess the comparative efficacy of Ardhamatrik Basti and Virechana Karma followed by Shamana Ausadha in the management of Kshina Shukra (Oligospermia).



 
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