| CTRI Number |
CTRI/2025/03/081872 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study on effect of therapeutic purgation followed by enema treatment as Erandmooladi Yapan Basti along with oral administration of Apatyakar Ghrita on low sperm count and low sperm motility. |
|
Scientific Title of Study
|
A Clinical Study On Effect Of Virecana Karma followed by Erandamuladi Yapana Basti along with Samana Snehapana by Apatyakara Ghrita in Kshina Shukra w.s.r. to Oligospermia and Low sperm motility. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Naitriben Pankajbhai Patel |
| Designation |
MD Panchakarma 2nd year PG scholar |
| Affiliation |
J.S. Ayurveda Mahavidyalaya. Nadiad.Kheda. Gujarat |
| Address |
Post graduate department of Panchakarma
J S Ayurveda Mahavidyalaya collage road Nadiad
Kheda
GUJARAT
387001
India
Kheda
GUJARAT
387001
India |
| Phone |
8320287463 |
| Fax |
|
| Email |
naitrypatel1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Kalapi B Patel |
| Designation |
Professor and HOD Department of Panchakarma |
| Affiliation |
J S Ayurveda Mahavidyalaya and P.D. Patel Aturveda Hospital |
| Address |
Post graduate department of Panchakarma
J S Ayurveda Mahavidyalaya collage road Nadiad
Kheda
GUJARAT
387001
India
Kheda
GUJARAT
387001
India |
| Phone |
9428661664 |
| Fax |
|
| Email |
drkalapi@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Kalapi B Patel |
| Designation |
Professor and HOD Department of Panchakarma |
| Affiliation |
J S Ayurveda Mahavidyalaya and P.D. Patel Aturveda Hospital |
| Address |
Post graduate department of Panchakarma
J S Ayurveda Mahavidyalaya collage road Nadiad
Kheda
GUJARAT
387001
India
Kheda
GUJARAT
387001
India |
| Phone |
9428661664 |
| Fax |
|
| Email |
drkalapi@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Sundar Ayurveda Pharmacy of J S Ayurveda Mahavidyalaya Nadiad Kheda Gujarat 387001 India |
|
|
Primary Sponsor
|
| Name |
J S Ayurveda Mahavidyalaya |
| Address |
J S Ayurveda Mahavidyalaya collage road Nadiad.Kheda
GUJARAT 387001 India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Naitri Pankajbhai Patel |
P D Patel Ayurveda Hospital |
Department of Striroga and Prasuti tantra OPD room no 132
Nadiad Kheda 387001 Gujarat
Kheda
GUJARAT |
8320287463
naitrypatel1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE FOR HUMAN RESEARCH |
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 | - | yApana-bastiH, यापन-बस्तिः | (Procedure Reference: Charak siddhisthan, Procedure details: after samyak virechan karma & samsarjan kram their will be sarvang abhayang and swedan followed by erand mooladi yapan basti done. )
(1) Medicine Name: erandamooladi yapan basti, Reference: Acharya Vidyadhara Shukla and Pro. Ravi Datta Tripathi, foreword by Acharya Priya vrata Sharma: Charaka Samhita vaidyamanorama hindi vyakhyana commentary by Chaukhambha sanskrita pratisthana Delhi, siddhisthan 12/15(2), Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 320(ml), Frequency: od, Duration: 15 Days | | 2 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-कर्म | (Procedure Reference: Charak sutrasthana, Procedure details: on 3rd day of abhyang & swedan, Erand sneha and dinadayal churna will be given for the virechan karma.)
(1) Medicine Name: Erand sneha, Reference: Charak sutra sthan, Route: Oral, Dosage Form: Taila, Dose: 70(ml), Frequency: od, Duration: 1 Days(2) Medicine Name: Dinadayal churna, Reference: Bhaishajya sara samgraha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 7(g), Frequency: od, Duration: 1 Days | | 3 | Intervention Arm | Procedure | - | snehapAna-karma, स्नेहपान-कर्म | (Procedure Reference: Charak siddhisthan, Procedure details: saman snehapan will be given to patients after virecana karma & samsarjan for totak 75 days (15 days in ipd and 60 days at home))
(1) Medicine Name: Apatyakar Ghrita, Reference: Acharya Vidyadhara Shukla and Pro. Ravi Datta Tripathi, foreword by Acharya Priya vrata Sharma: Charaka Samhita vaidyamanorama hindi vyakhyana commentary by Chaukhambha sanskrita pratisthana Delhi, chikitsa sthana 2/4shloka 9, page no.64., Route: Oral, Dosage Form: Ghrita, Dose: 20(ml), Frequency: od, Duration: 75 Days | | 4 | Intervention Arm | Procedure | - | snehapAna-karma, स्नेहपान-कर्म | (Procedure Reference: Charak siddhisthan, Procedure details: snehapana will be given to patients for 5 days in increasing quantity as per kostha in early morning.)
(1) Medicine Name: Apatyakar Ghrita, Reference: Acharya Vidyadhara Shukla and Pro. Ravi Datta Tripathi, foreword by Acharya Priya vrata Sharma: Charaka Samhita vaidyamanorama hindi vyakhyana commentary by Chaukhambha sanskrita pratisthana Delhi, chikitsa sthana 2/4shloka 9, page no.64., Route: Oral, Dosage Form: Ghrita, Dose: 40(ml), Frequency: bd, Duration: 5 Days | | 5 | Intervention Arm | Procedure | - | aBya~gga-karma, अभ्यंग-कर्म | (Procedure Reference: charak sutrasthan, Procedure details: after samyaka virechan karma & samsarjan karma ,sarvang abhyang will be given for 15 days.)
(1) Medicine Name: Narayan tail, Reference: Api part 1 ,chepter 8/23, Route: Topical, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Duration: 3 Days(2) Medicine Name: narayan taila, Reference: Api part 1 , chepeter 8/23, Route: Topical, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Duration: 15 Days | | 6 | Intervention Arm | Procedure | - | svedana-karma, स्वेदन-कर्म | (Procedure Reference: charak samhita, Procedure details: after samyak virechan karma & samsarjan kram, sarvang abhyang followed by sarvang bashpa svedan will be done.)
(1) Medicine Name: Nirgundi patra, Reference: Charaka sutra sthan, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 100(g), Frequency: od, Duration: 3 Days(2) Medicine Name: Nirgundi patra, Reference: charak sutra sthan, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 100(g), Frequency: od, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Male |
| Details |
Diagnosed & confirmed cases of Kshina shukra (oligospermia) based on signs symptoms and laboratory investigations.
|
|
| ExclusionCriteria |
| Details |
Patients suffering from any other clinical condition.
Patients contraindicated for Virechana and/or Basti.
Patients suffering from any sexually transmitted disease.
All congenital and surgical cases of impotence.
Zero sperm count.
Obstruction in the reproductive tract. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To find out the efficacy of Virecana karma followed by Eraṇḍamūlādi Yāpana Basti along with
Śamana Snehapāna by Apatyakara Ghṛta by observing the changes in sperm count and motility
in the patient of Kṣīṇa Śukra (oligospermia and low sperm count). |
after 3 weeks to 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To find out the changes in the signs & symptoms in patients of the KsÌ£iÌ„nÌ£a šukra (oligospermia
and low sperm count) during 8 weeks after discharge |
8 weeks after discharge |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/03/2025 |
| Date of Study Completion (India) |
10/07/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The final outcome of the
study has been given in the form of conclusion in this section. The
bibliography and the clinical proforma are lastly appended. |