| CTRI Number |
CTRI/2024/05/066599 [Registered on: 01/05/2024] Trial Registered Prospectively |
| Last Modified On: |
30/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Trial to Study the Effects of an Ayurvedic Ghrita Formulation, Mashadi Ghrita in the Patients of Ksheena Shukra |
|
Scientific Title of Study
|
A CLINICAL STUDY TO EVALUATE THE EFFICACY OF MASHADI GHRITA IN KSHEENA 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 |
Udutha Vikrant Shreehari |
| Designation |
PG Scholar |
| Affiliation |
Alvas Ayurveda Medical College, Moodubidre |
| Address |
Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodabidri,
Dakshina karnataka
Dakshina Kannada
KARNATAKA
574227
India
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8169353157 |
| Fax |
|
| Email |
uduthavicky@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Susheel Shetty |
| Designation |
HOD and Professor |
| Affiliation |
Alvas Ayurveda Medical College |
| Address |
Alvas Ayurveda Medical College,Vidyagiri, Moodabidri, Dakshina
karnataka
KARNATAKA
574227
India
page
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9980431676 |
| Fax |
|
| Email |
shettysusheel13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vikrant |
| Designation |
PG Scholar in the Deptartment of Kayachikitsa |
| Affiliation |
Alvas Ayurveda Medical College |
| Address |
Alvas Ayurveda Medical College,Vidyagiri, Moodabidri, Dakshina
karnataka
KARNATAKA
574227
India
page
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9980431676 |
| Fax |
|
| Email |
uduthavicky@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas Ayurveda Medical College,
Vidyagiri, Moodabidri
Dakshina Kannada, Karnataka, India, 574227 |
|
|
Primary Sponsor
|
| Name |
Dr Vikrant |
| Address |
Alvas Ayurveda Medical College and Hospital, Moodabidire, Dakshina Kannada, India, 574227 |
| 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 Udutha Vikrant Shreehari |
Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodubidire |
PG Studies in the Department of Kayachiktsa, Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodubidire
Dakshina Kannada
KARNATAKA |
8169353157
uduthavicky@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Clinical Ethics Committee Alvas Ayurveda Medical College, Vidyagiri, Moodabidire, India |
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: Mashadi Ghrita, Reference: Vaidya Manorama, Route: Oral, Dosage Form: Ghrita, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: - Ushna Jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
Patients who fulfill the diagnostic criteria.
Patients from any religion, occupation, or socio-economic class.
Patients are willing to participate in the study and ready to sign the informed consent form. |
|
| ExclusionCriteria |
| Details |
Male patients with absolute Azoospermia and Teratozoospermia.
Male patients on certain medications like antineoplastic agents (e.g., Nitrogen mustard,
procarbazine, vincristine, methotrexate), cimetidine, estrogen and methyltestosterone.
Patients have chromosomal disorders like Klinefelter’s syndrome.
Patients suffering from major systemic disorders like Tuberculosis, AIDS and sexual
Transmitted Diseases (STD) and other gonadal disorders like Testicular Atrophy, Testicular
Failure and orchitis, which may interfere with study, will be excluded.
Patients having any anatomical deformity in gonads (e.g., Cryptorchidism, Monorchidism) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
After the treatment period, the following symptoms
will be checked.
Volume
Color
Concentration
pH
Viscosity
Liquefaction Time
Sperm Morphology
Vitality
Motility
Seminal Fructose
Sperm Count |
After 60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
After the treatment period, the following symptoms
will be checked.
Desire
Orgasm
Rigidity
Erection
Ejaculation
Post Act Exhaustion |
On 0th, 31st & 61st days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
11/05/2024 |
| 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="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
|
This study is Single Arm Open Label Clinical Trial with Mashadi Ghrita 5ml BD (Total 10ml) as an interventional drug for the period of 60 days. This study is conducted on the patients of Ksheena Shukra (Oligospermia) aged 22 to 45 years with a sperm count of less than 20 million sperm/ml of semen, who gave written and legal consent to undergoing a clinical trial. Study will be conducted in Alva’s Ayurveda Medical College and Hospital, Vidyagiri, Moodabidri. The assessment will be done on 0th day, 31st day and 61st day. |