| CTRI Number |
CTRI/2025/07/091831 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
26/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect Of Ksheervidaryadi shukrakarak Basti On shukrakshay |
|
Scientific Title of Study
|
Evaluating The Efficacy Of Ksheervidaryadi
Shukrakarak Basti In The Management Of Shukrakshaya Randomized Controlled Clinical Trial |
| 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 Sachin Ramkrushna Dhule |
| Designation |
Md. Panchkarma Scholar |
| Affiliation |
Csmss Ayurved Mahavidyalaya And Rugnalaya Kanchanwadi Aurangabad |
| Address |
Opd no 15 Panchakarma Department
Csmss Ayurved Mahavidyalaya And Rugnalaya, Kanchanwadi, Aurangabad Maharashtra 431011
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9890172153 |
| Fax |
|
| Email |
sach1997in@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh Sonwane |
| Designation |
Associate professor |
| Affiliation |
Csmss Ayurved Mahavidyalaya And Rugnalaya Kanchanwadi Aurangabad |
| Address |
Opd no 15 Panchakarma Department
Csmss Ayurved Mahavidyalaya And Rugnalaya, Kanchanwadi, Aurangabad Maharashtra 431011
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9579773404 |
| Fax |
|
| Email |
ramesh10673@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sachin Ramkrushna Dhule |
| Designation |
Md. Panchakarma Scholar |
| Affiliation |
Csmss Ayurved Mahavidyalaya And Rugnalaya Kanchanwadi Aurangabad |
| Address |
Opd no 15 Panchakarma Department
Csmss Ayurved Mahavidyalaya And Rugnalaya, Kanchanwadi, Aurangabad Maharashtra 431011
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
989017253 |
| Fax |
|
| Email |
sach1997in@gmail.com |
|
|
Source of Monetary or Material Support
|
| Csmss Ayurved Mahavidyalaya And Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 |
|
|
Primary Sponsor
|
| Name |
CSMSS Ayurved Mahavidyalaya |
| Address |
Kanchanwadi, Aurangabad Maharashtra 431011 |
| Type of Sponsor |
Private medical college |
|
|
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 Sachin Ramkrushna Dhule |
C.S.M.S.S Ayurved Mahavidyalaya |
Opd no 15 Panchakarma Department
Csmss Ayurved Mahavidyalaya And Rugnalaya Kanchanwadi Aurangabad Maharashtra 431011
Aurangabad
MAHARASHTRA |
989017253
sach1997in@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC CSMSS Ayurved Mahavidyalaya And Rugnalaya |
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 | Procedure | - | basti | (Procedure Reference: Ashtang hridya kalpashtan 4/25, Procedure details: The patient will be asked to lie down on abhyanga table in left lateral position. Flexing the right hip & knee keeping on hip left leg- niruhbasti - ksheervidaryadi shukrakarak basti taken in bastiyantra . Lubrication of anus will be done with til tail. Basti will be given by applying equal pressure on bastiputak .
Duaration: Basti will be given 8 days in yog basti pattern.)
| | 2 | Comparator Arm | Procedure | - | basti | (Procedure Reference: Bhaishajya ratnavali, Procedure details: (Procedure Reference: Bhaishajya ratnavali , Procedure details: The patient will be asked to lie down on abhyanga table in left lateral position. Flexing the right hip & knee keeping on hip left leg- niruhbasti - mashyadi siddhaghrut matrabasti taken in bastiyantra . Lubrication of anus will be done with til tail. Basti will be given by applying equal pressure on bastiputak . Duaration: Basti will be given 15 days.
)
|
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
1)Patient presenting with pratyatma lakshan of ksheen shukra
2)Semen sample suggestive of oligospermia 15-40 million will be selected.
3)Shukra avisarga
4)Basti yogya
5)Irrespective of socioeconomic condition
6)Male patient age ranging from 21 to 60 years. |
|
| ExclusionCriteria |
| Details |
1)Patient with Azoospermia and Aspermia
2)Genetic defect
3)Klinefelter syndrome
4)Infection such as Std, Uti, viral illness, hereditary condition.
5)Basti ayogya
6)Patient with systemic disease will be excluded. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| sperm count |
8 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the basti in the management of shukrakshaya.
To study complication of ksheervidaryadi shukrakarak basti. |
8 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
06/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
06/08/2025 |
| 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 the failure of a couple to achieve pregnancy with regular unprotected sexual intercourse after 12 months or more.WHO defined infertility as the inability to conceive a child. Couple maybe considered infertile if after 2 years of regular sexual intercourse, without contraception, the woman has not become pregnant, and male infertility is one of the primary reason for it. Male infertility refers to males inability to achieve a pregnancy in a fertile female. Male infertility is commonly due to deficiency in the semen and semen quality. Recent study status on infertility states that 50% is related to reproductive anomalies or disorder in the males in which 90% of male infertility problems are related to oligospermia and other abnormalities in Semen analysis. However there are number of treatment like hormonal therapy intrauterine inseminization and the test tube baby available but it is not cost effective and not surety is there. That is the reason today to explore Ayurveda as mediator to treat this type of conditions. As per Ayurveda oligospermia can be considered as kSheenaShukra. In kSheenashukra there is diminish level of shukra in the infertile couples. In ayurvedic text many herbal preparation mention in the management of kSheenashukra, which are quite beneficial to treat this problem. In this case we will be using ksheervidaryadi shukra karak basti. Management of infertility in modern science include hormonal supplementations and assisted reproductive techniques. Regarding this eat also has limitations and adverse effect too. It is although a very expensive so a common man cannot afford it. India couples being more orthodox may not accept it whole heartedly. Owing to above mention problem of management, in our classics Aacharya charak explain basti as shukrabala pradascha. |