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CTRI Number  CTRI/2026/02/103662 [Registered on: 11/02/2026] Trial Registered Prospectively
Last Modified On: 30/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A Clinical Study to Assess the Effect of Swayamguptadi Bija Churna in Improving Low Sperm Count 
Scientific Title of Study   A clinical study to evaluate the effect of Swayamguptadi Bija churna in management of Kshina Shukra(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  Balaje G 
Designation  PG Scholar 
Affiliation  Sri Jayendra Saraswathi Ayurveda College and Hospital 
Address  3/1 Kazhuvamulli street, Behind Municipal office, Gandhi Mudhaliyar nagar,Thiruthuraipoondi,Thiruvarur dist
PG Department of Kayachikitsa, Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai. Thiruvallur TAMIL NADU 600123 India
Thiruvallur
TAMIL NADU
614713
India 
Phone  7373309177  
Fax    
Email  drbalajemdayurveda@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pradeep Kumar Moharana 
Designation  Professor 
Affiliation  Sri Jayendra Saraswathi Ayurveda College and Hospital 
Address  PG Department of Kayachikitsa, Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai. Thiruvallur TAMIL NADU 600123 India

Thiruvallur
TAMIL NADU
600123
India 
Phone  9444123608  
Fax    
Email  pkm_ayur@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Balaje G 
Designation  PG Scholar 
Affiliation  Sri Jayendra Saraswathi Ayurveda College and Hospital 
Address  3/1 Kazhuvamulli street, Behind Municipal office, Gandhi Mudhaliyar nagar,Thiruthuraipoondi,Thiruvarur dist

Thiruvallur
TAMIL NADU
614713
India 
Phone  7373309177  
Fax    
Email  drbalajemdayurveda@gmail.com  
 
Source of Monetary or Material Support  
Room no 17,Department of Kayachikitsa,Sri Jayendra Saraswathi Ayurveda College and Hospital,Nazarethpet,Chennai-600123 
 
Primary Sponsor  
Name  Balaje G 
Address  Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai Thiruvallur Tamil Nadu 600123 
Type of Sponsor  Other [[Self]] 
 
Details of Secondary Sponsor  
Name  Address 
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 BALAJE G  Sri Jayendra Saraswathi Ayurveda College and Hospital  Nazarathpet, Chennai, Tamilnadu, 600123 Thiruvallur Tamil Nadu
Thiruvallur
TAMIL NADU 
07373309177

drbalajemdayurveda@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Sri Jayendra Saraswathi Ayurveda College and Hospital  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: SWAYAMGUPTADI BIJA CHURNA , Reference: SUSRUTA CHIKITSA 26/33, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: GO dugdha), Additional Information: • Before dispensing the medicine, Koshta Shuddhi will be carried out with Avipatti churna (Astanga Hrdaya Kalpa Sthana 2/21) with Ushnodakam at morning, on Day 0. Dose will be decided according to Koshta assessment.
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  50.00 Year(s)
Gender  Male 
Details  The sperm count is less than or equal to 15 million per milliliter
Willing to participate and give informed consent
 
 
ExclusionCriteria 
Details  K/c/o Azoospermia.
K/c/o Genetic disorder that could affect spermatogenesis,
K/c/o Klinefelter syndrome, Kallmann’s syndrome.
History of Orchiectomy or Testicular trauma, Varicocele, Hydrocele.
Past h/o Mumps orchitis.
K/c/o Uncontrolled diabetes, sexually transmitted disease
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in total sperm count above 15 million/mL  90 days 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in symptoms of kshina shukra and other seminal parameters  90 days 
 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   26/02/2026 
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="2"
Months="0"
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 a growing global health problem and male infertility contributes significantly to it. Oligospermia is defined as a reduced sperm concentration and is one of the leading causes of male infertility. A large number of men worldwide are affected by infertility and in India a considerable proportion of infertile couples have male factor involvement. Low sperm count and poor sperm quality are responsible for most cases of male infertility and are influenced by lifestyle factors environmental exposure infections congenital causes and advancing age.

Although modern assisted reproductive techniques are available they are costly and impose emotional and financial stress on couples. Therefore there is a need for safe affordable and effective alternative treatment options.Ayurveda explains male infertility under conditions such as Kshina Shukra which occurs due to depletion or vitiation of Shukra Dhatu caused by imbalance of Doshas. Classical texts describe the use of Vajikarana and Rasayana therapies to improve Shukra Dhatu and reproductive health.

Swayamguptadi Bija Churna is a classical Ayurvedic formulation containing Atmagupta Ikshuraka and Sharkara which are known for their Vrishya and Brimhana properties. These drugs are believed to enhance Shukra Dhatu improve semen parameters and strengthen the male reproductive system. Avipatti Churna is used as an adjuvant to support digestion and absorption of the formulation.

However scientific clinical evidence supporting the efficacy of Swayamguptadi Bija Churna in oligospermia is limited. Hence the present study is planned to systematically evaluate the effect of Swayamguptadi Bija Churna in the management of Kshina Shukra or oligospermia using semen analysis parameters. This study aims to bridge the gap between classical Ayurvedic concepts and modern scientific validation and may provide an effective affordable and holistic treatment approach for male infertility.

 
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