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CTRI Number  CTRI/2019/05/019108 [Registered on: 14/05/2019] Trial Registered Prospectively
Last Modified On: 04/03/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   ‘Klaibya’ me Trikantakadi churna aur Vanga bhasma ka prayog 
Scientific Title of Study   “Preclinical and Clinical Evaluation of Trikantakadi Churna and Vanga Bhasma in the management of ‘Klaibya’ w.s.r. to 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 Binod Kumar Singh 
Designation  Ph.D. Scholar 
Affiliation  National Institute Of Ayurveda 
Address  PG Department Of Kayachikitsa, National Institute Of Ayurveda, Jorawar Singh Gate, Madhav Vilas Palace, Amer Road

Jaipur
RAJASTHAN
302002
India 
Phone  8448207879  
Fax    
Email  drbinodbaghel@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Udai Raj Saroj 
Designation  Associate Professor 
Affiliation  National Institute Of Ayurveda 
Address  PG Department Of Kayachikitsa, National Institute Of Ayurveda, Jorawar Singh Gate, Madhav Vilas Palace, Amer Road

Jaipur
RAJASTHAN
302002
India 
Phone  9983341119  
Fax    
Email  ursarojayu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Binod Kumar Singh 
Designation  Ph.D. Scholar 
Affiliation  National Institute Of Ayurveda 
Address  PG Department Of Kayachikitsa, National Institute Of Ayurveda, Jorawar Singh Gate, Madhav Vilas Palace, Amer Road

Jaipur
RAJASTHAN
302002
India 
Phone  8448207879  
Fax    
Email  drbinodbaghel@yahoo.com  
 
Source of Monetary or Material Support  
National Institute Of Ayurveda, Jorawar Singh gate, Amer road jaipur -302002 
 
Primary Sponsor  
Name  National Institute of Ayurveda 
Address  Near Jorawar singh gate Amer road 
Type of Sponsor  Research institution and hospital 
 
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 Binod Kumar Singh  OPD and IPD of PG Department of Kayachikitsa. NIA Hospital.  National Institute Of Ayurveda, Jorawar Singh Gate, Amer Road
Jaipur
RAJASTHAN 		 8448207879

drbinodbaghel@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, NATIONAL INSTITUTE OF AYURVEDA, JAIPUR  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Vanga Bhasma with Trikantakadi churna  20 clinically diagnosed and registered patients of ‘Klaibya’ will be treated by ‘Vanga Bhasma’ 250 mg with 6 gms of Trikantakkadi churna with luke warm milk before meal twice a day for 60 days (Oral medicine).  
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
Intervention  Trikantakadi Churna  20 clinically diagnosed and registered patients of ‘Klaibya’ will be treated by ‘Trikantakadi Churna’ 6 gms with luke warm milk before meal twice a day for 60 days (Oral medicine). 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  50.00 Year(s)
Gender  Male 
Details  1.Patients presenting with samanya of Klaibya.
2.Patients having reduction of sexual desire.
3.Unable to consummate the sexual act due to lack of erection, lack of rigidity at least 50 percent of coital instances.
4.Ejaculation before, on or just after penetration or unable to achieve partner satisfaction.
5.Patients willing to participate in the study. 
 
ExclusionCriteria 
Details  1. Disorder of sexual organ e.g. Hypospadias, Vericocele.
2. Patients having any systemic disorders like Tuberculosis, Cancer, Cardiovascular disease, Diabetes Mellitus, Venereal disease, HIV, Hypertension and Spinal injuries etc.
3. Patients having drug induced and iatrogenic klaibya (erectile dysfunction)
4. Erectile dysfunction due to nerve damage e.g. trauma, surgery.
5.Patients suffering from severe depression and anxiety. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Assessment of changes in specific symptoms of Klaibya and Erectile dysfunction.  60 days for each patients. 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in the objective parameters.  60 days for each patients. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "42"
Final Enrollment numbers achieved (India)="42" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   10/09/2019 
Date of Study Completion (India) 23/03/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 A critical Appraisal on Ageing process in Ayurvedatill under process.International Journal of Ayurveda and Pharma Research,Sep. 2020 Vol 8 Issue 9 Clinical Evaluation of efficacy of Navaka guggulu and Triphala kwatha in the management of Medoroga with special reference to obesity,International Journal of Ayurveda and Pharma Research. June 2020 Vol 8 Issue 6 Ayurvedic Review on Diagnosis and Management of Hridroga with the special reference to Cardiovascular Disease.Ayushdhara, May - June 2020 Vol 7 Issue 3 "Vajikara (Aphrodisiac) Potential of herbal drugs described in Vaidyajivana- A Review, Journal of Ayurveda Campus (jac) oct.2021; 2 (1) 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 AIMS AND OBJECTIVES: 

To evaluate the clinical efficacy of Trikantakadi Churna and Vanga Bhasma in the management of Klaibya (Erectyle dysfunction) and Reduction in Subjective parameters i.e. Nayati /Aharshanam (Loss of sexual desire), Dhvjanucchraya (Lack of Penile Erection), Lingashaithilya / mlalashishna (Lack of penile rigidity), Chirat praseka / badhnati shukra / nirveejam (delayed / retarded ejaculation), Apraharsha (Lack of orgasm), Maithune svasakrucchrata (Difficulty in breathing during sexual act), swinnagatra (perspiration during sexual act), Moghasankalpa (Lack of confidence), Moghachesta (Incompleteness of sexual act), Pandu varna (Pallor complexion), sudurbala (Weakness), alpa prana (lack of enthusiasm), vasti/vrushna/medhra vedana (pain in bladder/testis/penile), assessment of IIEF-15, assessment of Depression, assessment of anxiety and Objective parameters i.e Haematolagical test,  Biochemical test, Lipid profile, hormonal test etc.
 
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