| CTRI Number |
CTRI/2026/01/100190 [Registered on: 02/01/2026] Trial Registered Prospectively |
| Last Modified On: |
01/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of Sita-Palandu Yog and clomiphene citrate in Ksheenshukra |
|
Scientific Title of Study
|
A Randomised Controlled Clinical Trial to Evaluate The Efficacy of Sita-Palandu Yog In Management Of Ksheenshukra With Special Reference to 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 Maruti Machindra Jagtap |
| Designation |
PG Scholar |
| Affiliation |
Dr G D Pol Foundation YMT Ayurvedic Medical College and Hospital |
| Address |
DR G D POL FOUNDATION, YMT Ayurvedic Medical College And Hospital, 3rd Floor, Gynaec Dept, Sector- 4, Kharghar , Navi Mumbai
Raigarh
MAHARASHTRA
India
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9823544869 |
| Fax |
|
| Email |
marutijagtapstar1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seema Mehere |
| Designation |
Professor , HOD and PG Guide |
| Affiliation |
Dr G D Pol Foundation YMT Ayurvedic Medical College and Hospital |
| Address |
DR G D POL FOUNDATION, YMT Ayurvedic Medical College And Hospital, 3rd Floor, Gynaec Dept, Sector- 4, Kharghar , Navi Mumbai
Raigarh
MAHARASHTRA
India
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9930940403 |
| Fax |
|
| Email |
seema.mehre@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Maruti Machindra Jagtap |
| Designation |
PG Scholar |
| Affiliation |
Dr G D Pol Foundation YMT Ayurvedic Medical College and Hospital |
| Address |
DR G D POL FOUNDATION, YMT Ayurvedic Medical College And Hospital, 3rd Floor, Gynaec Dept, Sector- 4, Kharghar , Navi Mumbai
Raigarh
MAHARASHTRA
India
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9823544869 |
| Fax |
|
| Email |
marutijagtapstar1999@gmail,com |
|
|
Source of Monetary or Material Support
|
| DR G D Pol Foundation YMT Ayurvedic medical college and hospital |
|
|
Primary Sponsor
|
| Name |
DR MARUTI MACHINDRA JAGTAP |
| Address |
DR G D POL FOUNDATION,YMT Ayurvedic medical college And Hospital,3rd Floor,Gynaec dept,sec-4,kharghar,Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| 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 Maruti Machindra Jagtap |
DR G D POL FOUNDATION,YMT Ayurvedic medical college And Hospital. |
3rd Floor,Gynaec dept,Sec-4,Kharghar,Navi Mumbai
Raigarh
MAHARASHTRA |
9823544869
marutijagtapstar1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Dr G D pol foundation YMT ayurvedic medical college and charitable 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: Sita-palandu yog, Reference: Yogratnakar 16/5, Route: Oral, Dosage Form: Swaras/ Juice, Dose: 70(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm (Non Ayurveda) | | - | Tab clomiphene Citrate | Clomiphene Citrate 25 mg /day for 25 days then 5 day rest,this cycle repeated for 3 month |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
Diagnosed with oligospermia (sperm count less than 15 million/ml |
|
| ExclusionCriteria |
| Details |
Age below 21 and above 45 years
Sperm count greter than 15 million per ml
Dm
Major systemic illness
Varicocele
Azoospermia |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate effect of sita-palandu yog in the management of ksheenshukra with special referance to oligospermia |
1st visit- Baseline
2nd visit- after 30 days
3rd visit- after 60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess improvement in other semen parameters like
-Motility (progressive & total)
-Morphology (normal % forms)
- Viability
-PH
To study complete literature available in ayurvedic texts on ksheenshukra.
To study oligospermia according to modern medicine. |
1st visit- day zero
2nd visit- after 1 month
3rd visit -after 2 month
4 th visit -after 3month |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
12/01/2026 |
| 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="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
|
The Present Study is a PG Thesis Topic
By PG Scholar - DR MARUTI MACHINDRA JAGTAP and Guide Name - DR SEEMA MEHERE Title -A RANDOMISED CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY OF
SITA –PALANDU YOG IN MANAGEMENT OF KSHEENSHUKRA WITH SPECIAL REFERENCE TO OLIGOSPERMIA. According to inclusion and exclusion criteria
Grou p A 32 patients and Grou p B 32 patients will be selected
Grou p A ( intervention ) will be given sita palandu yog 70 ml empty stomach in morning and another 70ml after lunch for 3months Grou p B ( control/ comparative ) Tab clomiphene citrate 25mg after food OD for 25days then 5 days rest , cycle repeat for 3 months Total Duration of study is 1 year 6 months. |