| CTRI Number |
CTRI/2024/12/078231 [Registered on: 17/12/2024] Trial Registered Prospectively |
| Last Modified On: |
19/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical study to assess the clinical outcomes of Chatuh prasrutika Basti in the management of Erectile Dysfunction |
|
Scientific Title of Study
|
A clinical study to assess the clinical outcomes of Chatuh prasrutika Basti in the management of Erectile Dysfunction |
| 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 Ritesh Roy |
| Designation |
PG Scholar |
| Affiliation |
Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal (M.P) |
| Address |
PG Department of Panchakarma, room no 111 Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal(M.P) 462007
Bhopal
MADHYA PRADESH
462007
India |
| Phone |
8236809606 |
| Fax |
|
| Email |
ritesh.roy786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Babita Dash |
| Designation |
Assistant Professor |
| Affiliation |
Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal (M.P) |
| Address |
PG Department of Panchakarma, room no 111 Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal (M.P) 462007
Bhopal
MADHYA PRADESH
462007
India |
| Phone |
8109591573 |
| Fax |
|
| Email |
drmissdash@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ritesh Roy |
| Designation |
PG Scholar |
| Affiliation |
Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal(M.P) |
| Address |
PG Department of Panchakarma, room no 111 Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal(M.P) 462007
Bhopal
MADHYA PRADESH
462007
India |
| Phone |
08236809606 |
| Fax |
|
| Email |
ritesh.roy786@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal(M.P) 462007 |
|
|
Primary Sponsor
|
| Name |
Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal MP |
| Address |
PG Department of Panchakarma, Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal(M.P) 462007 |
| Type of Sponsor |
Government funding agency |
|
|
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 Ritesh Roy |
Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal(M.P) |
PG Department of Panchakarma Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal(M.P) 462007
Dhar
MADHYA PRADESH |
8236809606
ritesh.roy786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) Pt Khushilal Sharma Government Ayurveda Institute Bhopal (MP) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N529||Male erectile dysfunction, unspecified. 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: placebo, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 13 Days, anupAna/sahapAna: Yes(details: -sukhoshana jala), Additional Information: - | | 2 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Charaka Samhita siddhi sthana 8,& Sushruta Samhita chikitsa sthana 38 , Procedure details: 20 patients of this group will be administered with Chatuh Prasrutika Basti for 11 days. Prior to this, patient will be administered 2 Shodhan Basti for 2 days))
(1) Medicine Name: Shodhan Basti , Reference: Shushrut chikitsa sthana 38, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 760(ml), Frequency: od, Duration: 2 Days(2) Medicine Name: Chatuh Prasrutika Basti , Reference: : Charaka siddhi sthana 8, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 380(ml), Frequency: od, Duration: 11 Days |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
Patients above the age of 21 years and less than 50 years age.
Patients with signs and symptoms of Erectile dysfunction according to the special scoring system for sexual parameters.
Patients those fit for Basti Karma.
Patients who have given written consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
Patients below the age of 21 years and above 50 years.
Patients having other systemic illnesses like hypertension, diabetes mellitus, ischemic heart disease, malignancy or any acute infection.
Patients who are not willing to sign written consent to participate in the study.
Accidental injury of genital organ. |
|
|
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
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is expected that at the end of the study we would be able to demonstrate the effect of Chatuh Prasrutika Basti in the management of Erectile dysfunction. |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It is further expected that this study will be able to provide the information related to the safety and efficacy of Chatuh Prasrutika Basti in the management of Erectile dysfunction. |
11 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 |
|
Date of First Enrollment (India)
|
16/03/2025 |
| 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 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
|
From this study, It is expected that at the end of the study will be able to demonstrate the effect of Chatuh Prasrutika Basti in the management of Erectile dysfunction. It is further expected that this study will be able to provide the information related to the safety and efficacy of Chatuh Prasrutika Basti in the management of Erectile dysfunction |