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CTRI Number  CTRI/2024/07/070748 [Registered on: 16/07/2024] Trial Registered Prospectively
Last Modified On: 24/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Management Of Klaibya With Special Reference To Erectile Dysfunction 
Scientific Title of Study   An open label clinical trial to evaluate the efficacy of Vidangaadya Taila Uttar Basti and Pramehamihir Taila Upastha Basti followed by Amritprasha Ghrita in the management of Klaibya with special reference to 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  Dr Abhishek ranjan jha  
Designation  Pg scholar  
Affiliation  National institute of ayurveda  
Address  Room No 114, panchkarma department, national institute of ayurveda, jorawar singh gate, jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  7976818419  
Fax    
Email  Kabhi9615@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof. Dr. Gopesh mangal  
Designation  Professor & hod pg department of panchkarma  
Affiliation  National institute of ayurveda  
Address  Room No 114, panchkarma department, national institute of ayurveda, jorawar singh gate, jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  8619849011  
Fax    
Email  Gopesh.pk@nia.edu.in  
 
Details of Contact Person
Public Query
 
Name  Prof Dr Gopesh mangal  
Designation  Professor hod pg department of panchkarma  
Affiliation  National institute of ayurveda  
Address  Rroom No 114, panchkarma department, national institute of ayurveda, jorawar singh gate, jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  8619849011  
Fax    
Email  Gopesh.pk@nia.edu.in  
 
Source of Monetary or Material Support  
National institute of ayurveda, jaipur, Rajasthan, 302002, India  
 
Primary Sponsor  
Name  National institute of ayurveda  
Address  Madhav vilas palace,jorawar singh gate, amber road,jaipur, rajasthan india 302002.  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
nill  nill 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Abhishek Ranjan Jha   National Institute Of Ayurveda   Room 111, Panchkarma Department, Jorawar Singh Gate, Amer Road,Jaipur 302002
Jaipur
RAJASTHAN 
7976818419

kabhi9615@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute ethics committee of 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. Ayurveda Condition: KLAIBYAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Amritprasha ghrita , Reference: BHAISAJYA RATNAVALI 74 285 296,, Route: Oral, Dosage Form: Ghrita, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: milk), Additional Information: -
2Intervention ArmProcedure-uttara-bastiH, उत्तर-बस्तिः (Procedure Reference: CHARAK SIDHI 9 TRIMARMIYA ADHYAY 53 57,, Procedure details: 20 ML TAIL ADMINISTRATION BY INFANT TUBE/ RUBBER CATHER/ FOLEYS CATHATER THROUGH SYRINGE ))
(1) Medicine Name: VIDANGAADYA TAIL , Reference: CHARAK SIDHI 4 SNEHVYAPAD SIDHI 18 22, Route: Urethral, Dosage Form: Taila, Dose: 20(ml), Frequency: od, Duration: 15 Days
3Intervention ArmProcedure-svedanam, स्वेदनम् (Procedure Reference: CHARAK SUTRA 14 SVEDANIYA ADHYAYA, Procedure details: STHANIK MRIDU SVEDANA ON UPASTHA ( PENIS SHAFT REGION) WITH PREMAHMIHIR TAIL )
(1) Medicine Name: PREMAHA MIHIR TAILA, Reference: BHAISAJYA RATNAVALI 37 221 229, Route: Topical, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Duration: 15 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Male 
Details  1 Age : 18 to 60 years
2 Gender : Male
3 Patients presenting with Samanya Lakshana of
Klaibya (Erectile Dysfunction)
4 Unable to consummate the sexual act due to
lack of erection, lack of rigidity at least 50%
of coital instances.
5 Patients willing to participate in the study 
 
ExclusionCriteria 
Details  1 Spinal cord injury.
2 Major organic or psychosomatic disorder.
3 Poorly controlled Diabetes mellitus, Severe
Systemic diseases, Uncontrolled hypertension.
4 ED due to surgery of colon, prostate, bladder
or rectum.
5 Carcinoma of penis.
6 Hypospadias.
7 Phimosis.
8 Patients with possible effects of any
medication.
9 Patients with Venereal disease, HIV.
10 Congenital chordee
11 Congenital defect of genital organ 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 

1.Changes in score of Patient Questionnaire from
International Index of Erectile Function (IIEF)
2.Clinical Interpretation of Mlanashishnata-
a. No erection at all
b. Erection but not sustained
c. Sustained erection
d. Erection but not enough for penetration
e. Erection enough for penetration Successful
intercourse 
at baseline, after 2 weeks of treatment  
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcome of the study will be
assessed by changes of DSM V criteria score. 
after 4 weeks of complete treatment  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   30/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  30/07/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="29" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   INTRODUCTION
Inability to obtain or maintain an adequate erection for satisfying sexual activity is known as erectile dysfunction (ED). The achievement of a proper erection with enough stiffness for penetrative intercourse is the most crucial of the many phases off sexual response ;failure and unhappiness result from the absence of this phase. In classical ayurvedic texts, this condition is carefully described as Klaibya. Importantly, ED has a significant negative impact on a man’s quality of life, including loss of self-esteem, avoidance of intimacy, anxiety and depression, which in turn exacerbate sexual dysfunction. This also impacts the relationship between sexual partners, including negatively affecting sexual desire and satisfaction of partners. Furthermore, ED is considered an independent risk factor for the development of metabolic syndrome, cardiovascular disease and type 2 diabetes mellitus, sharing common underlying mediators, and therefore ED is considered an increased mortality risk. Its incidence increases drastically from about 6% in the age group 20-29 years, to 50-70% in the age group 40-79 years Its incidence has been projected to increase significantly to over 320 million by the year 2025. India has been dubbed as the impotence capital of the world due to the high incidence of the life style diseases and probably the largest population of males in the world. It has been selected for the present study to find out a better cure for a happy and healthy sexual life. After considering these facts present work is formulated to assess the efficacy of Vidangaadya Tail Uttar Basti and Pramehamihir Taila Upasth Basti followed by Amritprash Ghrita in the management of Klaibya w.s.r. erectile dysfunction. 
RESEARCH QUESTION   Is there any efficacy of Vidangaadya tail Uttar basti and Pramahamihir tail Upasth basti followed by Amritprash Ghrit in the management of Klaibya with special reference to erectile dysfunction? 
HYPOTHESIS         
Ho There is no efficacy of Vidangaadya Tail Uttar Basti and Pramahamihir Tail Upasth Basti followed by Amritprasha Ghrit in the management of Klaibya with special reference to erectile dysfunction.
HA There is effect of Vidangaadya Tail Uttar Basti and Pramahamihir Tail Upasth Basti followed by Amritprasha Ghrit in the management of Klaibya with special reference to erectile dysfunction.
AIM OF THE STUDY
To evaluate the efficacy of Vidangaadya Tail Uttar Basti and Pramehamihir tail Upasth Basti in the followed by Amritprash Ghrit in management of Klaibya with special reference to erectile dysfunction. 
OBJECTIVE OF THE STUDY 
To evaluate the clinical efficacy of Vidangaadya Tail Uttar Basti and Pramehamihir Tail Upasth Basti in Klaibya with special reference to erectile dysfunction. 
 
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