| CTRI Number |
CTRI/2025/09/094668 [Registered on: 12/09/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effect of Ardhamatrika Basti and Tritiya Baladi Yapana Basti in Ksheena Shukra (Oligozoospermia) |
|
Scientific Title of Study
|
Comparative Clinical Evaluation Of Ardhamatrika Basti And Tritiya Baladi Yapana Basti In Ksheena Shukra (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 |
Shubham Bhardhwaj |
| Designation |
PG Scholar Panchakarma |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar |
| Address |
Panchakarma Department Opd no.4 Patanjali Ayurveda Hospital Patanjali Yogpeeth Phase 1, Roorkee Road Haridwar Uttarakhand
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8219339081 |
| Fax |
|
| Email |
sb8209140@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Ketan Mahajan |
| Designation |
Professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar |
| Address |
Panchakarma Department Opd no.4 Patanjali Ayurveda Hospital Patanjali Yogpeeth Phase 1, Roorkee Road Haridwar Uttarakhand
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8979793731 |
| Fax |
|
| Email |
ketanmahajan82@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shubham Bhardhwaj |
| Designation |
PG Scholar Panchakarma |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar |
| Address |
Panchakarma Department Opd no.4 Patanjali Ayurveda Hospital Patanjali Yogpeeth Phase 1, Roorkee Road Haridwar Uttarakhand
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8219339081 |
| Fax |
|
| Email |
sb8209140@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Patanjali Yogpeeth Haridwar, India Pincode no.249405 |
|
|
Primary Sponsor
|
| Name |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar |
| Address |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan,Patanjali Yogpeeth Phase 1 Roorkee Road Haridwar Uttarakhand Pincode no. 249405 |
| 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 Shubham Bhardhwaj |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar (Uttarakhand) |
Panchakarma Department Opd no.4 Patanjali Ayurveda Hospital Patanjali Yogpeeth Phase 1, Roorkee Road Haridwar Uttarakhand
Hardwar
UTTARANCHAL |
8219339081
sb8209140@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Patanjali Ayurveda College |
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 | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Chakradatta Samhita 73/191-196, Procedure details: Procedure details: Niruha Basti Poorva Karma: After passing feaces, urine & flatus, the patient on empty stomach should be prepared with Abhyanga & Swedan. However, patient should not be very hungry. Pradhan Karma: Patient will be asked to lie down comfortably on his left side to keep his head on his arms in the form of pillow while keeping the body straight & relaxed. Then the patient will be asked to flex his right leg over his fully extended left leg. Thereafter anus & enema nozzle will be lubricated with oil. After removing air bubble, appropriate quantity of prepared Niruha Basti will be administered. Paschat Karma: Patient will be advised to lie on his back i.e. in supine position comfortably on the bed. Patient will be advised to empty his bowel after getting urge for defecation. Anuvasana Basti Poorva Karma: Patient will be given Abhyanga & Swedan followed with warm water bath & then patient will be advised to take food less by ¼ of the usual quantity. Ask him to eliminate feaces, urine or flatus if present. Pradhan Karma: Patient will be asked to lie down comfortably on his left side to keep his head on his arms in the form of pillow while keeping the body straight & relaxed. Then the patient will be asked to flex his right leg over his fully extended left leg. Thereafter anus & enema nozzle will be lubricated with oil. After removing air bubble, appropriate quantity of prepared. Anuvasana Basti will be administered. Paschat Karma: Patient will be advised to lie down in supine position, & gentle tapping over the buttocks will be done followed by lifting of legs 3 times. Patient will be advised to pass the bowel after getting the urge for defecation.)
(1) Medicine Name: Ardhamatrika Basti, Reference: Chakradatta Samhita 73/191-196, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 488(ml), Frequency: od, Duration: 9 Days | | 2 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Charak Samhita Siddhi Sthan 12/15(9), Procedure details: Procedure details: Niruha Basti Poorva Karma: After passing feaces, urine & flatus, the patient on empty stomach should be prepared with Abhyanga & Swedan. However, patient should not be very hungry. Pradhana Karma: Patient will be asked to lie down comfortably on his left side to keep his head on his arms in the form of pillow while keeping the body straight & relaxed. Then the patient will be asked to flex his right leg over his fully extended left leg. Thereafter anus & enema nozzle will be lubricated with oil. After removing air bubble, appropriate quantity of prepared Niruha Basti will be administered. Paschat Karma: Patient will be advised to lie on his back i.e. in supine position comfortably on the bed. Patient will be advised to empty his bowel after getting urge for defecation. Anuvasana Basti Poorva Karma: Patient will be given Abhyanga & Swedan followed with warm water bath & then patient will be advised to take food less by ¼ of the usual quantity. Ask him to eliminate feaces, urine or flatus if present. Pradhana Karma: Patient will be asked to lie down comfortably on his left side to keep his head on his arms in the form of pillow while keeping the body straight & relaxed. Then the patient will be asked to flex his right leg over his fully extended left leg. Thereafter anus & enema nozzle will be lubricated with oil. After removing air bubble, appropriate quantity of prepared Anuvasana Basti will be administered. Paschat Karma: Patient will be advised to lie down in supine position, & gentle tapping over the buttocks will be done followed by lifting of legs 3 times. Patient will be advised to pass the bowel after getting the urge for defecation.)
(1) Medicine Name: Tritiya Baladi Yapana Basti, Reference: Charak Samhita Siddhi Sthan 12/15(9), Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 488(ml), Frequency: od, Duration: 9 Days |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
46.00 Year(s) |
| Gender |
Male |
| Details |
1.Patients Age between 21- 46 years.
2.Patients with clinical presentation oh Ksheena Shukra.
3.Patient having sperm count less than 15 million/ml.
4.Patient fit for Basti Karma
|
|
| ExclusionCriteria |
| Details |
1.Sexually transmitted diseases.
2.Azoospermia.
3.Undescended testis.
4.Testis cancer.
5.Any diseases like Tuberculosis, CKD, CAD, HIV, Cirrhosis of Liver, Diabetes, Thyroid disorders etc.
6.Varicocele.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Parameters that will be assessed:
1. Semen analysis(low sperm count)
2.Sarvadehagata Lakshana i.Daurbalya ii.Bhrama
iii.Panduta
iv.Shrama
3.Maithunagata Lakshana
i.Klaibya
ii.Alpachesta
4.Shukragata Lakshana
i.Alpa Shukra pravriti
ii.Shukra avisarga
|
9,30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Sexual desire
2.Erection
3.Rigidity
4.Orgasm |
9,30 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 |
|
Date of First Enrollment (India)
|
23/09/2025 |
| 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) |
Open to Recruitment |
|
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
|
This study is a Comparative Clinical Evaluation of Ardhamatrika Basti and Tritiya Baladi Yapana Basti in Ksheena Shukra (Oligozoospermia) This will be conducted on 60 randomly selected patients from OPD/IPD of Panchakarma department of Patanjali Bhartiya Ayurvigyan Evun Anusandhan Sansthan, Haridwar. Patients will be divided into 2 groups- 30 patients will be administered Ardhamatrika Basti and 30 patients will be administered Tritiya Baladi Yapana Basti in modified Kala Basti schedule. Follow-up will be taken after 1 month assessment to be done on the basis of subjective and objective parameters as discussed earlier. |