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CTRI Number  CTRI/2025/03/081872 [Registered on: 07/03/2025] Trial Registered Prospectively
Last Modified On: 21/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A clinical study on effect of therapeutic purgation followed by enema treatment as Erandmooladi Yapan Basti along with oral administration of Apatyakar Ghrita on low sperm count and low sperm motility. 
Scientific Title of Study   A Clinical Study On Effect Of Virecana Karma followed by Erandamuladi Yapana Basti along with Samana Snehapana by Apatyakara Ghrita in Kshina Shukra w.s.r. to Oligospermia and Low sperm motility. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Naitriben Pankajbhai Patel 
Designation  MD Panchakarma 2nd year PG scholar 
Affiliation  J.S. Ayurveda Mahavidyalaya. Nadiad.Kheda. Gujarat 
Address  Post graduate department of Panchakarma J S Ayurveda Mahavidyalaya collage road Nadiad Kheda GUJARAT 387001 India

Kheda
GUJARAT
387001
India 
Phone  8320287463  
Fax    
Email  naitrypatel1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Kalapi B Patel  
Designation  Professor and HOD Department of Panchakarma 
Affiliation  J S Ayurveda Mahavidyalaya and P.D. Patel Aturveda Hospital 
Address  Post graduate department of Panchakarma J S Ayurveda Mahavidyalaya collage road Nadiad Kheda GUJARAT 387001 India

Kheda
GUJARAT
387001
India 
Phone  9428661664  
Fax    
Email  drkalapi@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Dr Kalapi B Patel  
Designation  Professor and HOD Department of Panchakarma 
Affiliation  J S Ayurveda Mahavidyalaya and P.D. Patel Aturveda Hospital 
Address  Post graduate department of Panchakarma J S Ayurveda Mahavidyalaya collage road Nadiad Kheda GUJARAT 387001 India

Kheda
GUJARAT
387001
India 
Phone  9428661664  
Fax    
Email  drkalapi@rediffmail.com  
 
Source of Monetary or Material Support  
Sundar Ayurveda Pharmacy of J S Ayurveda Mahavidyalaya Nadiad Kheda Gujarat 387001 India  
 
Primary Sponsor  
Name  J S Ayurveda Mahavidyalaya 
Address  J S Ayurveda Mahavidyalaya collage road Nadiad.Kheda GUJARAT 387001 India 
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 Naitri Pankajbhai Patel  P D Patel Ayurveda Hospital  Department of Striroga and Prasuti tantra OPD room no 132 Nadiad Kheda 387001 Gujarat
Kheda
GUJARAT 		 8320287463

naitrypatel1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITEE FOR HUMAN RESEARCH   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 ArmProcedure-yApana-bastiH, यापन-बस्तिः (Procedure Reference: Charak siddhisthan, Procedure details: after samyak virechan karma & samsarjan kram their will be sarvang abhayang and swedan followed by erand mooladi yapan basti done. )
(1) Medicine Name: erandamooladi yapan basti, Reference: Acharya Vidyadhara Shukla and Pro. Ravi Datta Tripathi, foreword by Acharya Priya vrata Sharma: Charaka Samhita vaidyamanorama hindi vyakhyana commentary by Chaukhambha sanskrita pratisthana Delhi, siddhisthan 12/15(2), Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 320(ml), Frequency: od, Duration: 15 Days
2Intervention ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: Charak sutrasthana, Procedure details: on 3rd day of abhyang & swedan, Erand sneha and dinadayal churna will be given for the virechan karma.)
(1) Medicine Name: Erand sneha, Reference: Charak sutra sthan, Route: Oral, Dosage Form: Taila, Dose: 70(ml), Frequency: od, Duration: 1 Days
(2) Medicine Name: Dinadayal churna, Reference: Bhaishajya sara samgraha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 7(g), Frequency: od, Duration: 1 Days
3Intervention ArmProcedure-snehapAna-karma, स्नेहपान-कर्म (Procedure Reference: Charak siddhisthan, Procedure details: saman snehapan will be given to patients after virecana karma & samsarjan for totak 75 days (15 days in ipd and 60 days at home))
(1) Medicine Name: Apatyakar Ghrita, Reference: Acharya Vidyadhara Shukla and Pro. Ravi Datta Tripathi, foreword by Acharya Priya vrata Sharma: Charaka Samhita vaidyamanorama hindi vyakhyana commentary by Chaukhambha sanskrita pratisthana Delhi, chikitsa sthana 2/4shloka 9, page no.64., Route: Oral, Dosage Form: Ghrita, Dose: 20(ml), Frequency: od, Duration: 75 Days
4Intervention ArmProcedure-snehapAna-karma, स्नेहपान-कर्म (Procedure Reference: Charak siddhisthan, Procedure details: snehapana will be given to patients for 5 days in increasing quantity as per kostha in early morning.)
(1) Medicine Name: Apatyakar Ghrita, Reference: Acharya Vidyadhara Shukla and Pro. Ravi Datta Tripathi, foreword by Acharya Priya vrata Sharma: Charaka Samhita vaidyamanorama hindi vyakhyana commentary by Chaukhambha sanskrita pratisthana Delhi, chikitsa sthana 2/4shloka 9, page no.64., Route: Oral, Dosage Form: Ghrita, Dose: 40(ml), Frequency: bd, Duration: 5 Days
5Intervention ArmProcedure-aBya~gga-karma, अभ्यंग-कर्म (Procedure Reference: charak sutrasthan, Procedure details: after samyaka virechan karma & samsarjan karma ,sarvang abhyang will be given for 15 days.)
(1) Medicine Name: Narayan tail, Reference: Api part 1 ,chepter 8/23, Route: Topical, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Duration: 3 Days
(2) Medicine Name: narayan taila, Reference: Api part 1 , chepeter 8/23, Route: Topical, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Duration: 15 Days
6Intervention ArmProcedure-svedana-karma, स्वेदन-कर्म (Procedure Reference: charak samhita, Procedure details: after samyak virechan karma & samsarjan kram, sarvang abhyang followed by sarvang bashpa svedan will be done.)
(1) Medicine Name: Nirgundi patra, Reference: Charaka sutra sthan, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 100(g), Frequency: od, Duration: 3 Days
(2) Medicine Name: Nirgundi patra, Reference: charak sutra sthan, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 100(g), Frequency: od, Duration: 15 Days
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  40.00 Year(s)
Gender  Male 
Details  Diagnosed & confirmed cases of Kshina shukra (oligospermia) based on signs symptoms and laboratory investigations.
 
 
ExclusionCriteria 
Details  Patients suffering from any other clinical condition.
Patients contraindicated for Virechana and/or Basti.
Patients suffering from any sexually transmitted disease.
All congenital and surgical cases of impotence.
Zero sperm count.
Obstruction in the reproductive tract.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To find out the efficacy of Virecana karma followed by Eraṇḍamūlādi Yāpana Basti along with
Śamana Snehapāna by Apatyakara Ghṛta by observing the changes in sperm count and motility
in the patient of KsÌ£iÌ„nÌ£a Åšukra (oligospermia and low sperm count). 		 after 3 weeks to 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To find out the changes in the signs & symptoms in patients of the KsÌ£iÌ„nÌ£a šukra (oligospermia
and low sperm count) during 8 weeks after discharge 		 8 weeks after discharge 
 
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)   20/03/2025 
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   Around 17.5% of the adult population – roughly 1 in 6 worldwide – is having infertility, x this is a major health challenge globally. Lifetime prevalence was 17.8% in high-income countries and 16.5% in low- and middle-income countries, infertility is often perceived as an issue that affects women, but male factor infertility contributes to approximately half of instances. xi Unfortunately, the burden of male infertility is often unrecognized and its causes are poorly understood, meaning men can be sidelined during treatment and the burden of medically assisted reproductive techniques falls on the woman, even if she herself has no reproductive issues. This lack of understanding and information means that substantial emotional stress is put on both members of the couple seeking infertility treatment. Around 50% of infertility cases in India are attributed to male factors, highlighting the importance of addressing male reproductive health. xii There are so many research going on related to this subject since 2 to 3 decades. Researchers are trying to find some sure answer for male infertility and as solution, assisted procreation techniques are introduced. In case of treatment failure, depending on the severity of male infertility, IUI, IVF or micro fertilization (ICSI) can be tried. Still the problem persists regards cost affectivity and success rate. Again it can be said that, they are treating infertility not the Oligospermia. Ayurvedic management of KsÌ£iÌ„nÌ£a Åšukra has encouraging results. Hence this study is planned to explore the effectiveness of Ayurvedic management of KsÌ£iÌ„nÌ£a Åšukra (oligospermia and low sperm motility). 
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