| CTRI Number |
CTRI/2025/03/081531 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ayurvedic trial treatment for increase sperm count |
|
Scientific Title of Study
|
Comparative study to evaluate the efficacy of Baladi Yapana Basti and Ashwgandha Ghrita Snehapana in Ksheen Shukra (oligospermia)-A randomized control 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 Gaurav Kumar Meena |
| Designation |
PG Scholar |
| Affiliation |
Chaudhary brahm prakash ayurved charak sansthan |
| Address |
Room no.123 ,PG Department of Panchkarma,Ch. Brahm Prakash Ayurved Charak Sansthan Khera Dabar South west
Room no. 144 Department of Panchkarma ,Ch. Brahm Prakash Ayurved Charak Sansthan Khera Dabar south west
South West
DELHI
110073
India |
| Phone |
9521902006 |
| Fax |
|
| Email |
gauravmedico777@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pankaj Kumar Katara |
| Designation |
Assistant Professer |
| Affiliation |
Chaudhary brahm prakash ayurved charak sansthan |
| Address |
Room no. 144 Department of Panchkarma ,Ch. Brahm Prakash Ayurved Charak Sansthan Khera Dabar south west
Room no. 144 Department of Panchkarma ,Ch. Brahm Prakash Ayurved Charak Sansthan Khera Dabar south west
South West
DELHI
110073
India |
| Phone |
9910430500 |
| Fax |
|
| Email |
drpankajkatara@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pankaj Kumar Katara |
| Designation |
Assistant Professer |
| Affiliation |
Chaudhary brahm prakash ayurved charak sansthan |
| Address |
Room no. 144 Department of Panchkarma ,Ch. Brahm Prakash Ayurved Charak Sansthan Khera Dabar south west
Room no. 144 Department of Panchkarma ,Ch. Brahm Prakash Ayurved Charak Sansthan Khera Dabar south west
South West
DELHI
110073
India |
| Phone |
9910430500 |
| Fax |
|
| Email |
drpankajkatara@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chaudhary Brahm Prakash Ayurved Charak Sansthan khera dabur najafagarh new delhi 110073 |
|
|
Primary Sponsor
|
| Name |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Khera Dabar,Najafgarh ,New Delhi-110073 |
| Type of Sponsor |
Government 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 Pankaj Kumar Katara |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
Room no. 144 Department of Panchkarma ,Ch. Brahm Prakash Ayurved Charak Sansthan Khera Dabar south west
South West
DELHI |
9910430500
drpankajkatara@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee CBPACS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N461||Oligospermia. Ayurveda Condition: KLAIBYAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: ASHWGANDHA GHRIT, Reference: CHARAK CHIKITSA CHAPTER 3, Route: Oral, Dosage Form: Ghrita, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 16 Days, anupAna/sahapAna: Yes(details: LUKEWARM WATER), Additional Information: - | | 2 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Charak Siddhi Sthan, Procedure details: The patient is positioned in the left lateral position. A lubricated Bastiyantra is gently inserted and basti dravya enterd slowly. After that the patient is advised to lie in the same position.)
(1) Medicine Name: Yapana Basti, Reference: Charak Siddhi sthan Adhyay 12 Shlok 16, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 600(ml), Frequency: od, Duration: 16 Days |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
Inability to achieve pregnancy after one year of married couples unprotected coitus.
Sperm count less than 15 million per ml .
Male patients belonging to 21yr to 45 years of age.
Patient suitable for Basti Karma,Snehpana.
Patient willing to give written informed consent for treatment.
|
|
| ExclusionCriteria |
| Details |
Patients with azoospermia and aspermia.
Genetic defects like Klinefelter’s syndrome.
Patients with diseases like Varicocele, Accessory sex gland infection, Sexually transmitted diseases, and systemic diseases like DM etc. Patient not suitable for Basti Karma and Snehapana.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This ayurvedic intervention may lead to 30-45 percent increase in sperm count |
0,16th Day,48th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| yapna basti is better than ahswgandha ghrit snehpana |
follow up on 48th day |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
10/03/2025 |
| 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="0"
Days="12" |
|
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 study is comparative study to evaluate the efficacy of baladi yapna basti and ashwagandha ghrit snehpana in ksheen shukra oligospermia ,A randomized control trial , in one group baladi yapna basti , The first assesment on 0th day ,the second assesment on 16th day and 3rd assesment on 48th day follow up on 48th day.while a second group Ashwagnadha ghrit snehpana .the first assesment on 0th day second assesment on 16th day and the 3rd asessment on 48th day follow up in 48th days follow up in 48th day. patient will be enrolled in opd and ipd of pg department of panchkarma chaudhary brahm prakash ayurved charak sansthan.yapna is better than ashwgandha ghrit snehpana |