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CTRI Number  CTRI/2025/04/083822 [Registered on: 01/04/2025] Trial Registered Prospectively
Last Modified On: 22/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effect of medicated enema (using Payasyadi vasthi medicines) in low sperm concentration (Oligospermia) 
Scientific Title of Study   Effect of Payasyadi Vasthi in 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 Jithesh V 
Designation  MD scholar 
Affiliation  Government Ayurveda College Thiruvananthapuram 
Address  Department of Panchakarma Government Ayurveda college Thiruvananthapuram Government Ayurveda Panchakarma hospital Poojappura Kerala

Thiruvananthapuram
KERALA
695012
India 
Phone  9633276500  
Fax    
Email  jitgavc@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jithesh V 
Designation  MD scholar 
Affiliation  Government Ayurveda College Thiruvananthapuram 
Address  Department of Panchakarma Government Ayurveda college Thiruvananthapuram Government Ayurveda Panchakarma hospital Poojappura Kerala

Thiruvananthapuram
KERALA
695012
India 
Phone  9633276500  
Fax    
Email  jitgavc@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Manju P S 
Designation  Associate Professor 
Affiliation  Government Ayurveda College Thiruvananthapuram 
Address  Department of Panchakarma Government Ayurveda college Thiruvananthapuram Government Ayurveda Panchakarma hospital Poojappura Kerala

Thiruvananthapuram
KERALA
695012
India 
Phone  9847317295  
Fax    
Email  manjumahesh1977@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurveda College Thiruvananthapuram, kerala, India pin 695001 
 
Primary Sponsor  
Name  Dr Jithesh V 
Address  Department of Panchakarma Government Ayurveda College Thiruvananthapuram Government Ayurveda Panchakarma hospital Poojappura Kerala 695012 
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 Jithesh V  Government Ayurveda College Panchakarma hospital poojappura  OP number 1 Government Ayurveda college Panchakarma hospital Poojappura 695012
Thiruvananthapuram
KERALA 		 9633276500

jitgavc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Government Ayurveda College Thiruvananthapuram, kerala, India.  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 (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Ashtanga hridaya 19th chapter, Procedure details: Participant will be asked to take very light food in the early morning before 8 am. Before administration of vasthi,vitals will be recorded & will be given Abhyanga & Sweda over kati, udara, parshwa pradesha. medicine used is payasyadi vasthi medicine (734 ml)and will be administered in between 10.30 am to 11 am. Position of the participant will be made to lie in the left lateral position by keeping left leg straight & right leg flexed at the knee joint. Anus will be anointed by oil & also tip of vasti netra. The per rectal examination will be carried out to rule out loaded rectum or any other obstruction. Unplugging the vasti netra, its tip will be closed with left index finger after evacuating the air. Vasti netra will be then gently introduced into the anal opening & then the putaka will be pressed slowly & steadily to push the medicine into the rectum. Participant will be asked to breathe deeply through mouth or count numbers during the introduction. Vasti netra will be withdrawn with a little amount of medicine retained in the putaka. Participant will be advised to lie down in supine position till the urge of defecation occurs. After the bowels become clear, will be advised to take hot water bath & to take light food like rice. Then vitals will be noted.)
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  50.00 Year(s)
Gender  Male 
Details  Participant of age group 25 to 50 years with total sperm concentration less than
20million per ml.
Participant fit for Enema as per Ayurvedic classical texts. 
 
ExclusionCriteria 
Details  Participant with Chronic uncontrolled Diabetes Mellitus, Hypertension.
Diagnosed case of Genetic defect like Klinefelter syndrome
Bilateral Varicocele
Accessory sex gland infections
Diagnosed cases of STDs
H/O lower lumbar spinal injury
Any systemic disorder affecting testicular functions 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
a) Total sperm count
b) Sperm concentration 		 0th day and 90th day 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   10/04/2025 
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 Yet Recruiting 
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  
Infertility is defined as a failure to achieve a pregnancy after 12 months or more of regular unprotected coitus. Estimates suggest that approximately one in every six people of reproductive age worldwide experience infertility in their lifetime. According to recent report of WHO on status of infertility in India, of all infertility cases, approximately 50% is due to male factor infertility, owing to the reproductive anomalies in the male. Oligospermia is one of the major leading causes of male infertility. It is a condition of suboptimal concentration of spermatozoa in the ejaculated semen to ensure successful fertilization of an ovum. 2024 ICD
10 CM Code N46.1 define Oligospermia in human as a sperm count below 20 million per millilitre semen.
According to Ayurveda Oligospermia can be correlated to Ksheenasukra. Ksheenasukra is vata-pita predominant condition. Payasyadi vasthi is a vrishya vasthi having Brimhana and vata-pitta samana property. It is mentioned in Ashtanga hridayam kalpa sthanam and Charaka samhitha sidhisthana. Vasthi itself is a remedy for vata pradhana dosha. Hence the aim of the study is to find out the effect of Payasyadi Vasthi in Oligospermia.
 The study design is Pre and post assessment interventional study with a sample size of 20 Males with an age group 25 to 50 years who are diagnosed with Oligospermia attending IPD of Govt. Ayurveda Panchakarma hospital, Thiruvananthapuram. Assessment of this study is done with quantitative semen analysis. Participants will be administered with Payasyadi Vasthi for continuous 7 days. The result will be assessed with regard to changes in the outcome variable as in semen analysis. The pre post test data will be assessed with appropriate statistical method.
Keywords: Oligospermia, Ksheena sukra, Payasyadi vasthi.
 
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