| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N461||Oligospermia. Ayurveda Condition: SUKRAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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. |