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CTRI Number  CTRI/2020/10/028518 [Registered on: 21/10/2020] Trial Registered Prospectively
Last Modified On: 19/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Management of Impotence by ayurvedic method 
Scientific Title of Study   An Etiopathological Study Of Klaibya wsr to Impotence and Its Therapeutic Study (Upshayatmak parikshana) With Gokshuradi Churna 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  LOKESH KUMAR 
Designation  MD SCHOLAR 
Affiliation  Government PG Ayurveda College and Hospital  
Address  Room no 19 Department of Roga nidan Academic block Government PG Ayurveda College and Hospital Varanasi

Varanasi
UTTAR PRADESH
221002
India 
Phone  8840328731  
Fax    
Email  dr.rintu85@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Avadhesh Kumar 
Designation  Reader and HOD department of rognidan 
Affiliation  Government PG ayurveda college and hospital Varanasi 
Address  Room no 19 PG department of rognidan Academic block Government PG Ayurveda college and hospital Varanasi

Varanasi
UTTAR PRADESH
221002
India 
Phone  9455262663  
Fax    
Email  dravadheshsaroj@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Avadhesh Kumar 
Designation  Reader and HOD department of rognidan 
Affiliation  Government PG ayurveda college and hospital Varanasi 
Address  Room no 19 PG department of rognidan Academic block Government PG Ayurveda college and hospital Varanasi

Varanasi
UTTAR PRADESH
221002
India 
Phone  9455262663  
Fax    
Email  dravadheshsaroj@gmail.com  
 
Source of Monetary or Material Support  
Government PG Ayurveda College and Hospital Varanasi  
 
Primary Sponsor  
Name  Government PG Ayurveda College and Hospital  
Address  Room no 19 Department of Roga Nidan Academic block Givernment PG Ayurveda College and Hospital Varanasi 
Type of Sponsor  Government 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 Avadhesh Kumar  Government PG Ayurveda College and Hospital  Room no 19 Department of Roga Nidan Acedemic Block Government PG Ayurveda College and Hospital
Varanasi
UTTAR PRADESH 		 9455262663

dravadheshsaroj@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC Government PG Ayurveda college and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N469||Male infertility, unspecified. Ayurveda Condition: Disease of Sukravaha srotas,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Gokshuradi Churna  Minimum 40 no of patients with sign and symptoms of Klaibya will be given Gokshuradi Churna 5g twice daily for 30 days 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  70.00 Year(s)
Gender  Male 
Details  Adult male patients suffering from Klaibya or Impotence.
Male patients suffering from infertility due to impotence 
 
ExclusionCriteria 
Details  Female patients.
Patients suffering with diseases other than Klaibya.
Patients having mechanical cause of Klaibya like antisperm antibodies condition, obstruction or surgical process.
Other chronic diseases like STDs 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Relief in sign and symptoms of Klaibya  30 days 
 
Secondary Outcome  
Outcome  TimePoints 
Improve quality of life of patients suffering from Klaibya  45 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   26/10/2020 
Date of Study Completion (India) 30/12/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
under this clinical study minimum 40 patients of Klaibya will be treated with Gokshuradi churna. The constituents of this drug are Gokshura, Shatavari, Kshuraka, Kapikacchu, Nagabala and Atibala. This churna is described in classical text Chakradutta in the chapter of Vrishyadhikara. The action of this drug is Vrishya which improves the Shukra dosha. According to Charak Klaibya is originated from Shukradosha so due to improvement in Shukradosha by different actions of Shukrashrutikara, Shukravriddhikara and Vrishya. It is a nervine tonic which increases Sexual vigor and stamina by increasing strength of body and mind. Due to properties like Madhura rasa, guru, snigddha  guna, Sheeta virya and Vrishya action improve the erectile dysfunftion. Kapikacchu improves the sperm count by enhancing spermatogenesis.
 Kshuraka churna with milk provides strength to the nervous system. Nagabala and Kapikacchu have Shukral properties. Shatavari is also a Shukra Vridhikar.
The period of trial will be one month with 7 days follow up. dose will be 5gm twice daily orally with milk. patients will be selected from OPD and IPD and Diagnosed on the basis of sign and symptoms and necessary laboratory investigation. assessment will be done and conclusion will be drawn after completion of study.  
 
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