| CTRI Number |
CTRI/2026/01/100263 [Registered on: 02/01/2026] Trial Registered Prospectively |
| Last Modified On: |
30/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
efficacy of erandmul churna and kapikacchu Beej churna in ksheenshukara |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF ERANDMUL
CHURNA AND KAPIKACCHU BEEJ CHURNA IN THE MANAGEMENT OF KSHEENSHUKRA
WITH SPECIAL REFERENCE TO OLIGOZOOSPERMIA. |
| 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 Pratik Shamrao Waghmode |
| Designation |
PG Scholar |
| Affiliation |
Dr G D Pol Foundation ymt Ayurvedic Medical college And Hospital |
| Address |
Dr G.D.Pol YMT Ayurvedic Medical College and Hospital,3 rd Floor Gynaec Dept Sector -4 Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India
Dr G.D.Pol YMT Ayurvedic Medical College and Hospital,3 rd Floor Gynaec Dept Sector -4 Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8308061924 |
| Fax |
|
| Email |
pratikwaghmode929@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nishigandha Bhavake |
| Designation |
Associate Professor, PG Guide. |
| Affiliation |
Dr G D Pol Foundation ymt Ayurvedic Medical college |
| Address |
Dr G.D.Pol YMT Ayurvedic Medical College and Hospital,3 rd Floor Gynaec Dept Sector -4 Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India
Dr G.D.Pol YMT Ayurvedic Medical College and Hospital,3 rd Floor Gynaec Dept Sector -4 Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8108150590 |
| Fax |
|
| Email |
nishigandhabhavake@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pratik Shamrao Waghmode |
| Designation |
PG Scholar |
| Affiliation |
Dr G D Pol Foundation ymt Ayurvedic Medical |
| Address |
Dr G.D.Pol YMT Ayurvedic Medical College and Hospital,3 rd Floor Gynaec Dept Sector -4 Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India
Dr G.D.Pol YMT Ayurvedic Medical College and Hospital,3 rd Floor Gynaec Dept Sector -4 Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8308061924 |
| Fax |
|
| Email |
pratikwaghmode929@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR G D POL FOUNDATION, YMT Ayurvedic Medical College And Hospital, Sector- 4, Kharghar , Navi Mumbai |
|
|
Primary Sponsor
|
| Name |
Dr Pratik Shamrao Waghmode |
| Address |
DR G D POL FOUNDATION, YMT Ayu rvedic Medical College And Hospital, 3rd Floor, Gy naec Dept, Sector- 4, Kharghar , Navi Mumbai |
| 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 Pratik Shamrao Waghmode |
Dr GD Pol Fou ndation YMT Ayu rvedic MedicCollege and Hospital |
3rd Floor, Gy naec Dept, Navi Mumbai
Raigarh
MAHARASHTRA
Raigarh
MAHARASHTRA |
8308061924
pratikwaghmode929@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Dr G D pol fou ndation 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: Erandmul churna, Reference: Charak sutra 25/40, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -jala), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kapikacchu beej churna, Reference: Bhavprakash Guduchadi varga, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -jala), Additional Information: _ |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
Patient presenting with pratyatmik lakshana of ksheenshukra i.e shukraavisarga, medravrushan vedana,maithun ashakt8 etc. With semen samples suggestive of oligozoospermia.
1.Sperm count less than 15 million /millilitre
2.Male patients of age ranging from 21 to 45 years |
|
| ExclusionCriteria |
| Details |
1.pt with azoospermia,aspermia and necrospermia.
2.Major systemic illness such as DM hypertension HIV congenital reproductive disorder
3.Genetic disorder like klinefelters syndrome
4.Patient with knkwn case of surgical illness to ilioiguinal scrotal area like varicocele accessary sex gland infection. |
|
|
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 study comparative effect of erandmul churn and kapikacchu beej churn in management of ksheenshukra with special reference to oligozoospermia . |
1st visit day0
2nd visit day 30
3rd visit day 60
4th visit day 90
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study the etiopathology of ksheenshukra in ayurvedic modern and scientific view
2.To asses the improvement in other semen parameter motility morphology viability. |
1st visit day0
2nd visit day 30
3rd visit day 60
4th visit day 90
|
|
|
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 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
|
The Present Study is a PG Thesis Topic By PG Scholar -Dr Pratik Shamrao Waghmode and Guide Name- Dr Nishigandha Bhavake
Title- A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF ERANDMUL CHURNA AND KAPIKACCHU BEEJ CHURNA IN THE MANAGEMENT OF KSHEENSHUKRA WITH SPECIAL REFERENCE TO OLIGOZOOSPERMIA.
According to inclusion and exclusion Group A 32 patients and Group B 32 patients will be selected Group A ( intervention) will be given Erandmul churn 6gm after food BD for 90 days Group B ( comparative) will be given Kapikacchu beej churn 6gm after food BD for 90 days
Total Duration of study is 1 years 6 months. |