| CTRI Number |
CTRI/2025/12/098455 [Registered on: 04/12/2025] Trial Registered Prospectively |
| Last Modified On: |
03/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
effect of eledi gutika in low level of sperm count |
|
Scientific Title of Study
|
RANDOMIZED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFECT OF ELADI GUTIKA ON KSHEEN SHUKRA (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 Snehal Bhaurao Akhare |
| Designation |
PhD Scholar |
| Affiliation |
CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Chhatrapati Sambhajinagar |
| Address |
CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Chhatrapati Sambhajinagar
Prasuti Tantra Evum Stree Roga Department, CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi, Chhatrapati Sambhajinagar
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
7350877991 |
| Fax |
- |
| Email |
snehalakhare25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amol Anandrao Havale |
| Designation |
Associate Professor (PTSR) |
| Affiliation |
CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Chhatrapati Sambhajinagar |
| Address |
Prasuti Tantra Evum Stree Roga Department, CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Chhatrapati Sambhajinagar
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9225306614 |
| Fax |
- |
| Email |
amolhavale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Snehal Bhaurao Akhare |
| Designation |
PhD Scholar |
| Affiliation |
CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Chhatrapati Sambhajinagar |
| Address |
Prasuti Tantra Evum Stree Roga Department CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Chhatrapati Sambhajinagar
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
7350877991 |
| Fax |
- |
| Email |
snehalakhare25@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
CSMSS Ayurved Mahavidyalaya and Rugnalaya Chhatrapati Sambhajinagar |
| Address |
Chhatrapati Shahu Maharaj Shikshan Sanstha Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Chhatrapati Sambhajinagar Maharashtra 431001 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Snehal Bhaurao Akhare |
CSMSS Ayurved Mahavidyalaya and Rugnalaya Chhatrapati Sambhajinagar Maharashtra 431001 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Snehal Bhaurao Akhare |
CSMSS Ayurved Mahavidyalaya and Rugnalaya Sambhajinagar Maharashtra 431001 |
CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Sambhajinagar Maharashtra 431001
Aurangabad
MAHARASHTRA |
7350877991
snehalakhare25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instutional Ethical Committee CSMSS Ayurved Mahavidyalaya Chhatrapati Sambhajinagar |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: ELADI GUTIKA, Reference: CHARAK CHIKTSA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 2.5(g), Frequency: bd, Bhaishajya Kal: Muhurmuhu, Duration: 90 Days, anupAna/sahapAna: Yes(details: -), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | tab clomiphene citrate 25 mg | tab clomiphene citrate 25 mg twice a day for 25 days with 5 days rest and cycle being continue for 3 months |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
1. Diagnosed Patient of Oligspermia after semen analysis report.
2. Patient having lakshanas of ksheen shukra.
3. Patients willing for treatment.
4. Age group between 25-35 yrs. |
|
| ExclusionCriteria |
| Details |
1. Patients with severe illness.
2. Patients with aspermia, necrospermia.
3. Patient taking treatment for infertility, oligospermia, hormonal treatment
within last 3 months.
4. Diagnosed patients of anatomical deformity which related to
oligospermia like varicocele.
5. Diagnosed patient of diabetes.
6. Diagnosed patient of obstructive oligospermia. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
changes in Ejaculation, Medhrashool,Erection, Libido ,
changes in values of Sperm Count,Sperm motility, testestron hormone |
on 0 day and on 90th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study Shukra Dhatu vikruti in detail.
2. To find out any co-relation between Shukra Dhatu vikruti & sperm
disorders.
3. To study the effect of Eladi Gutika on sperm count.
4. To study the effect of Eladi Gutika on Testosterone hormone in Ksheen
Shukra.
|
Assessed at 0 days, 30 day , 60 day & 90 day |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/01/2026 |
| 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="2"
Months="0"
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
|
Many studies of Ayurvedic herbs, panchakarma have been conducted on oligospermia condition but they are time consuming. It was needed to easy and additional health benefits for society hence present topic are selected for study. In modern oligospermia treated with stem cell therapy, hormonal treatment which are too costly and it leads to many side effects on health so considering all these facts Eladi Gutika is selected for study. |