| CTRI Number |
CTRI/2024/05/066866 [Registered on: 06/05/2024] Trial Registered Prospectively |
| Last Modified On: |
03/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative Evaluation Of The Efficacy Of Standard Market Preparation Tablet And Swayamguptadi Vati In The Management Of Klaibya (Erectile Dysfunction) |
|
Scientific Title of Study
|
Comparative Evaluation of the efficacy of standard market preparation (Tablet) and swayamguptadivati
in the management Of Klaibya (Erectile Dysfunction): A randomized clinical 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 Sourabh Deshmukh |
| Designation |
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
Wardha
MAHARASHTRA
442001
India |
| Phone |
9404337799 |
| Fax |
|
| Email |
ayurrulz@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Trupti Deshmukh |
| Designation |
Assistant Professor |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Centre ,Salod Hirapur Wardha |
| Address |
Room No 32 Department of Balrog Mahatma gandhi ayurved
college hospital and research centre Wardha MAHARASHTRA
Wardha
MAHARASHTRA
442001
India |
| Phone |
7020299894 |
| Fax |
|
| Email |
Truptithakre555@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sourabh Deshmukh |
| Designation |
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
Wardha
MAHARASHTRA
442001
India |
| Phone |
9404337799 |
| Fax |
|
| Email |
ayurrulz@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 Sourabh Deshmukh |
Mahatma Gandhi Ayurved College Hospital and Research Centre |
OPD and IPD of
Kayachikitsa
Department Room no
30
Wardha
MAHARASHTRA |
9404337799
ayurrulz@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Ayurved College, Hospital & Research Centre, 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 | 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: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: SWAYAMGUPTADI VATI , Reference: Samhita, 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 less than 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)
|
15/05/2024 |
| 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="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
|
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 |