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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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


 
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