| CTRI Number |
CTRI/2025/02/081112 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
12/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Ayurvedic treatment in the management of erectile dysfunction |
|
Scientific Title of Study
|
Effect of selected Ayurvedic treatment protocol in 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 |
Akshaydas TP |
| Designation |
2nd year PG scholar Department of Kayachikitsa |
| Affiliation |
Government Ayurveda college Thiruvananthapuram |
| Address |
Kayachikitsa OP room number 2 and IP
Government Ayurveda college Thiruvananthapuram
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9946702470 |
| Fax |
|
| Email |
akshaydastp9946@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suneeshmon MS |
| Designation |
Associate Professor Department of Kayachikitsa |
| Affiliation |
Government Ayurveda College Thiruvananthapuram. |
| Address |
OP department of kayachikitsa op number 2
Government Ayurveda College Thiruvananthapuram.
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9846009359 |
| Fax |
|
| Email |
drsuneeshmonkc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Akshaydas TP |
| Designation |
2nd year PG scholar Department of Kayachikitsa |
| Affiliation |
Government Ayurveda college Thiruvananthapuram |
| Address |
Kayachikitsa OP room number 2 and IP
Government Ayurveda college Thiruvananthapuram
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9946702470 |
| Fax |
|
| Email |
akshaydastp9946@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda college Thiruvananthapuram Kerala India
pin 695001 |
|
|
Primary Sponsor
|
| Name |
Government Ayurveda college Thiruvananthapuram |
| Address |
Government Ayurveda college Thiruvananthapuram Kerala India PIN 695001 |
| Type of Sponsor |
Other [Government Ayurveda college Thiruvananthapuram] |
|
|
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 Akshaydas TP |
Government Ayurveda college Thiruvananthapuram |
Kayachikitsa OP room number 2 and IP
Government Ayurveda college Thiruvananthapuram PIN 695001
Thiruvananthapuram
KERALA |
09946702470
akshaydastp9946@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Ayurveda college Thiruvananthapuram Kerala India |
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 | Intervention Arm | Procedure | - | aCasnehaH, अच्छस्नेहः | (Procedure Reference: astanga hridaya, Procedure details: according to agni bala gritha will be given till attaining samyak snighdha lakshana)
(1) Medicine Name: kalyanaka gritha, Reference: astanga hridaya, Route: Oral, Dosage Form: Ghrita, Dose: 100(ml), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Procedure | - | dIpana , दीपन | (Procedure Reference: astanga hridaya, Procedure details: deepan pachana will be done with hinguvachadi choorna )
(1) Medicine Name: hinguvachadi choorna, Reference: astanga hridaya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Duration: 7 Days | | 3 | Intervention Arm | Procedure | - | aBya~ggaH, अभ्यंग | (Procedure Reference: astanga hridaya, Procedure details: whole body abhyanga will be done for 30 min)
(1) Medicine Name: dhanwantharam thailam, Reference: astanga hridaya, Route: Topical, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Duration: 3 Days | | 4 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-कर्म | (Procedure Reference: astanga hridaya, Procedure details: medicine will be given according to kostha and agni bala)
(1) Medicine Name: avipathy choorna , Reference: astanga hridaya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 24(g), Frequency: od, Duration: 1 Days | | 5 | Intervention Arm | Drug | Classical | | (1) Medicine Name: yasthi madhu choornam, Reference: astanga hridaya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -madhu gritha milk), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Male |
| Details |
Male participants Erectile dysfunction of age group 25 to 55 years having IIEF-5 Score below 22 will be selected |
|
| ExclusionCriteria |
| Details |
Diagnosed cases of patients suffering from sexually transmitted diseases
Post surgical Erectile dysfunction
Diabetes mellitus
Infectious diseases
Major neurological problem
vascular disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of treatment will be analysed by IIEF-5 Questionnaire |
0th and 56thday |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ability to maintain erection sufficiently |
0th and 56thday |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
N/A |
|
Date of First Enrollment (India)
|
03/03/2025 |
| 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="6"
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
|
This study about the Effect of selected Ayurvedic treatment protocol in the management of erectile dysfunction . This includes initial deepana pachana with hinguvachadi churnam followed by snehapanam with kalyanakam gritham and abyangham ushma swedam with Dhanwantharam tailam .After this virechana with avipathy churnam and then peyadi kramam . yashti madhu churnam with madhu ,gritham and milk will be administered as vajeekarana oushada .The treatment will be done in 20 male patients age 25 to 55 satisfying the inclusion criteria for a period of 43-55 days. The assessment will be done by using IIEF-5 Questionnaire. |