| CTRI Number |
CTRI/2021/02/031047 [Registered on: 05/02/2021] Trial Registered Prospectively |
| Last Modified On: |
21/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Akarakarabha vati in the management of erectile dysfunction |
|
Scientific Title of Study
|
An open lable single arm clinical study on the effectiveness of Akarakarabha vati in the management of Klaibya (Erectile dysfunction) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sunil Sabasannavar Jinnappa |
| Designation |
2nd year Post Graduate Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
Thanniruhalla B M Road
Hassan 573201 Karnataka India Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
Hassan Hassan KARNATAKA 573201 India |
| Phone |
7795270420 |
| Fax |
|
| Email |
suniljsjain108@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Girish K J |
| Designation |
Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Department of Kayachikitsa
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
Thanniruhalla B M Road
Hassan 573201 Karnataka India Department of Kayachikitsa
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
Hassan Hassan KARNATAKA 573201 India |
| Phone |
9448646855 |
| Fax |
|
| Email |
girideepa@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Girish K J |
| Designation |
Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Department of Kayachikitsa
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
Thanniruhalla B M Road
Hassan 573201 Karnataka India Department of Kayachikitsa
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
Hassan Hassan KARNATAKA 573201 India |
| Phone |
9448646855 |
| Fax |
|
| Email |
girideepa@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
Thanniruhalla B M Road
Hassan 573201 Karnataka.
Ph No 08172256460
email ID college@sdmcahhassan.org |
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
Thanniruhalla B M Road
Hassan 573201 Karnataka India |
| Type of Sponsor |
Private medical college |
|
|
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 Sunil Sabasannavar Jinnappa |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
Department of Kayachikitsa
OPD No 04
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
Thanniruhalla B M Road
Hassan 573201 Karnataka India Hassan KARNATAKA |
7795270420
suniljsjain108@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan |
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
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Vati - Akarakarabha vati
|
Dose - 500 mg twice a day after food Anupana - warm milk
Duration - 30 days |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
1. Minimum 3 months history of erectile dysfunction.
2. Age-25 to 60 years.
3. Fairly good glycemic condition (DMT2).
4. Those subjects ready to participate and follow the instruction and     sign the informed consent form.
|
|
| ExclusionCriteria |
| Details |
Subjects with,
1. K/C/O essential hypertension and cardiac, hepatic, renal disorders 2. Significant anatomical penile deformity
3. History of prostatectomy or penile implant |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in penile erection, rigidty, sexual desire |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Increase in semen count |
45 days |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/02/2021 |
| 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="20" |
|
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
|
SUMMARY- Sexual health and functions are important determinants of quality of life. Sexual problems affect physical and psychosocial health and may have a significant impact on the quality of life. Erectile dysfunction(ED) is a type of sexual disorder characterized by the inability to develop or maintain an erection of penis during sexual act. Cardio vascular diseases, diabetes, depression, alcohol, smoking, neurological disease and trauma are the risk factors for the ED and it is increasingly prevalent with age. Approximately 40% of men are affected at age 40 and nearly 70% at age of 70. ED is known as kalibya which is a shukrapradoshaja vikara caused due to atyadika amla lavana kshara viruddha ahara sevana, veeryakshaya, bhaya, shoka, avishwas, streedoshadarshana, and due abhigata. Both sharirika and manasika bhavas are involved in the klaibya. Although lifestyle modification and psychotherapy are considered as first line of treatment in the ED, men presenting with ED expects the physician to help them with the measures and medication that can have improved result. So in this study Akarakarabha (Anacyclus pyrethrum) vati is selected, which is having katu rasa, ruksha teekshna guna, ushna veerya and katu vipaka and possesses vrusya balavardaka properties. Because of the ushna and uttejaka quality, it acts on the prajanana smastana as vajikararana and shukrasthambana. This study aims at evaluating the effectiveness of Akarakarabha vati in the management of klaibya. Data will be collected using case report from designed by incorporating all aspects for the study. Such collected data will be tabulated and analyzed using SPSS (Statistical Package for Social Sciences) version 20 and using appropriate statistical test. OBJECTIVES To evaluate the efficacy of Akarakarabha vati in the management of klaibya (erectile dysfunction) METHODOLOGY: Interventional clinical study RESEARCH DESIGN: Open labeled single arm prospective clinical trial
SAMPLING TECHNIQUE: Convenient sampling SAMPLE SIZE: 20
|