| CTRI Number |
CTRI/2023/01/048777 [Registered on: 05/01/2023] Trial Registered Prospectively |
| Last Modified On: |
11/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Vrishya Gutika In The Management Of Klaibya (Erectile Dysfunction) |
|
Scientific Title of Study
|
Comparative Evaluation Of The Efficacy Of Standard Market Preparation Tablet And Vrishya Gutika In The Management Of Klaibya (Erectile Dysfunction): A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhishek Anil Patil |
| Designation |
PG Scholar |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha |
| Address |
Room No 30 Department of Kayachikitsa Mahatma Gandhi Ayurved
College Hospital and Research Centre Wardha
MAHARASHTRA
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9881872300 |
| Fax |
|
| Email |
abhi.neuro@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sourabh Deshmukh |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha |
| Address |
Room No 30 Department of Kayachikitsa Mahatma gandhi ayurved
college hospital and research centre
Wardha
MAHARASHTRA
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9404337799 |
| Fax |
|
| Email |
ayurrulz@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhishek Anil Patil |
| Designation |
PG Scholar |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha |
| Address |
Room No 30 Department of Kayachikitsa Mahatma Gandhi Ayurved
College Hospital and Research Centre Wardha
MAHARASHTRA
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9881872300 |
| Fax |
|
| Email |
abhi.neuro@gmail.com |
|
|
Source of Monetary or Material Support
|
| The subjects will be recruited from Kayachikitsa OPD and IPD of Mahatma Gandhi Ayurved
College Hospital and Research Centre Salod Hirapur Wardha and peripheral camps |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Ayurved College Hospital and Center |
| Address |
Room No 30 Department of Kayachikitsa Mahatma Gandhi ayurved
college hospital and research centre
Wardha
MAHARASHTRA
442001
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 Abhishek Patil |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha |
OPD and IPD of
Kayachikitsa
Department Room no
30 Mahatma Gandhi
Ayurved College
Hospital and Research
Centre Salod Hirapur
Wardha
Wardha
MAHARASHTRA
Wardha
MAHARASHTRA |
9881872300
abhi.neuro@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N528||Other male erectile dysfunction. Ayurveda Condition: KLAIBYAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vrishya Gutika, Reference: Charak Chikitsa 2/4 30-32), Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: water), Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Standard Market Preparation Tablet, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
Patients willing to participate in the study and give written informed consent.
Patients with partial or complete erectile dysfunction reported with symptoms.
Each mentioned a patient with IIEF identified sexual dysfunction.
Patients having total testosterone level < 249ng/mL |
|
| ExclusionCriteria |
| Details |
Current treatment with antihypertensive medication.
Subject who have significant heart disease.
History of neurological disorder.
Homosexual person.
History of penile trauma, injury, surgery.
Subjects with history of significant central nervous system injuries (including stroke or
spinal cord injury) within the last 6 month. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in the levels of Sr Testosterone |
30 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in IIEF Questionnaire Scale |
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/01/2023 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The volunteers will be informed about the study protocol. willing participants will be randomly
selected as per computer generated table. Clinical research format will be prepared and validated.
Prior to the study approval will be taken from IEC, MGACH RC, Salod (H) Wardha and CTRI
registration will be done. After selection, each participant will be tested individually and selected
according to selection criteria. They will be divided into two groups as the trial is a parallel group,
randomized, open clinical, standard controlled trial. It will include a 30 days treatment period and follow up on 0 and 30th day.
|