FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2017/01/007668 [Registered on: 10/01/2017] Trial Registered Prospectively
Last Modified On: 10/01/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Siddha
Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical study of Venneer Noi (Dhat Syndrome) with Siddha Medical Therapy  
Scientific Title of Study   An open clinical trial of Poly Herbal Siddha Drug Venpoosanai Lekiyam (Internal medicine) and Ulunthu Thylam (External medicine) in the treatment of Venneer Noi (Dhat Syndrome) with and without Psycho Education Therapy 
Trial Acronym  Dhat Syndrome 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vallipuram Anavarathan 
Designation  MD Siddha PG Scholar 
Affiliation  National Institute of Siddha 
Address  PG Scholar, Department of Sirappu Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai 600047, TamilNadu, India.

Kancheepuram
TAMIL NADU
600047
India 
Phone  9962723482  
Fax    
Email  valanavarathan@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Associate Professor Dr NJ Muthukumar  
Designation  Head of the Department -Sirappu Maruthuvam 
Affiliation  National Institute of Siddha 
Address  Head of the the Department and Associate Professor, Department of Sirappu Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai 600047, TamilNadu, India.

Kancheepuram
TAMIL NADU
600047
India 
Phone  9962006843  
Fax  044-22381314  
Email  njmuthu@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vallipuram Anavarathan 
Designation  MD Siddha PG Scholar 
Affiliation  National Institute of Siddha 
Address  PG Scholar, Department of Sirappu Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai 600047, TamilNadu, India.

Kancheepuram
TAMIL NADU
600047
India 
Phone  9962723482  
Fax    
Email  valanavarathan@yahoo.com  
 
Source of Monetary or Material Support  
National Institute of Siddha  
 
Primary Sponsor  
Name  AYOTHIDOSS PANDITHAR HOSPITAL  
Address  National Institute of Siddha, Tambaram Sanatorium, Chennai 600047. 
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 Vallipuram Anavarathan  National Institute of Siddha, Department of Sirappu Maruthuvam, Out Patient Division, Room No. 3.  Out Patients Divisions, Department of Sirappu Maruthuvam, Room No. 3, of the Ayodidoss Pandithar Hospital of National Institute of Siddha, Tambaram Sanatorium,Kancheepuram District, Chennai 600047, TamilNadu, India.
Kancheepuram
TAMIL NADU 		 9962723482

valanavarathan@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, National Institute of Siddha  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy actively working MD Siddha PG Scholar  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  External Medicine - Ulunthu thylam (Oil)  Ulunthu Thylam is an Oil based external Medicine - Quantity sufficient (approximately 15 Milli liter) for external application on head and penis in twice a day for totally 48 days 
Intervention  Internal Medicine: Venpoosani Lekiyam   Venpoosani Lekiyam as a internal medicine by Oral route, - 05 grams, twice a day with milk and after meals for totally 48 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Male 
Details  • Weakness, anxiety, sleeplessness, mild depression and guilt which is attributed to semen loss.
• Loss of semen through nocturnal emissions and masturbation frightens the individual as he believes it to be harmful to the body.
• Report a white discharge in their urine which they feel is semen.
• Mention that passing semen during defecation
• Sexual dysfunction may or may not be present.
• Willing to give specimen of blood and sperm for the investigations before and after treatment.
• Willing to participate in Psycho - education therapy session

 
 
ExclusionCriteria 
Details  •Diabetes mellitus
•Severe Cardiac Diseases
•Severe Respiratory Diseases
•Acute and chronic Renal Diseases
•Needed for Surgical Treatment
•Alcohol and Substance Abuse
•Other severe Psychiatric Illness
•Mentally Challenged
•Physically Challenged
•Severe Malignancy Diseases
•Any other chronic Illness
 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Outcome will be assecced by before and after intrvention throgh DSSC score.
Primary Outcome
1. Comparison before and after intervention with DSSC
2. Categorization by the DSSC scoring
• DSSC scoring ≤ 40 - Good
• DSSC scoring 41 to 80 - Moderate
• DSSC scoring 81 to 12 - Mild
• DSSC scoring ≥ 12 – Nil 		 Time points is fourty eight (48) days
Primary Outcome
1. Comparison before and after intervention with DSSC Score
2. Categorisation by the DSSC scoring
• DSSC scoring ≤ 40 - Good
• DSSC scoring 41 to 80 - Moderate
• DSSC scoring 81 to 12 - Mild
• DSSC scoring ≥ 12 – Nil

 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary Outcome
The effectiveness of Psycho-education by comparing before and after treatment 		 Secondary Outcome
The effectiveness of Psycho-education by comparing before and after treatment 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 1/ Phase 2 
Date of First Enrollment (India)   16/01/2017 
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="0"
Months="9"
Days="10" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   First submit to as a dissertation for partial fulfilment of MD Siddha PG Course 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This study is a dissertation study for the partial fulfilment of MD Siddha PG study programme.
This is a open clinical trail will be conduct at Ayodidoss Pandithor Hospital, National Institute of Siddha, Tambaram Sanatorium, Chennai 600047, TamilNadu, India under TamilNadu Dr. MGR Medical University.
I Got the IEC approval on 05.10.2015, Now I am Proceeding to the authentication of Trial drugs ingredients and also preparing the trial medicine. 
I have plan to start the clinical trial on July 05th 2016 under the Supervision of my Course Supervisor and will be complete the Clinical trial on April 2017. then Dissertation writing work will start and on July will be Submit for. evaluation.     
 
Close