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CTRI Number  CTRI/2024/05/068164 [Registered on: 31/05/2024] Trial Registered Prospectively
Last Modified On: 31/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Siddha 
Study Design  Other 
Public Title of Study   Clinical evaluation of siddha medicine Vithuvagai chooranam for Aan maladu (Male infertility due to Oligospermia) 
Scientific Title of Study   Single centric non randomised open clinical trial phase II in “Aan maladu”(Male infertility due to Oligospermia) with Siddha medicine “Vithuvagai chooranam” among the patients attending OPD at Government siddha medical college hospital, Chennai 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vignesh S 
Designation  PG Scholar 
Affiliation  Government Siddha medical college Arumbakkam 
Address  Post graduate Department of Pothu maruthuvam, Government siddha medical college, Arumbakkam, chennai

Chennai
TAMIL NADU
600106
India 
Phone  9095699009  
Fax    
Email  text2vickyy@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anbu N 
Designation  HOD and Professor 
Affiliation  Government siddha medical college arumbakkam 
Address  Post graduate department of Pothu maruthuvam, Government. Siddha medical college, Arumbakkam, Chennai

Chennai
TAMIL NADU
600106
India 
Phone  9443279412  
Fax    
Email  nanbu.sumi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Anbu N 
Designation  HOD and Professor 
Affiliation  Government siddha medical college arumbakkam 
Address  Post graduate department of Pothu maruthuvam, Government. Siddha medical college, Arumbakkam, Chennai

Chennai
TAMIL NADU
600106
India 
Phone  9443279412  
Fax    
Email  nanbu.sumi@gmail.com  
 
Source of Monetary or Material Support  
Government siddha medical college Arumbakkam, chennai 600106 Tamilnadu India 
 
Primary Sponsor  
Name  Vignesh S 
Address  Post graduate department of pothu maruthuvam, Government siddha medical college, Arumbakkam, Chennai 600106 Tamilnadu India  
Type of Sponsor  Other [Other(self)] 
 
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 Vignesh S  Government siddha medical college Arumbakkam  Room no S1, Department of PG Pothu maruthuvam, Government siddha medical college Hospital,Arumbakkam, chennai 600106 Tamilnadu India
Chennai
TAMIL NADU 		 9095699009

text2vickyy@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Government siddha medical college, Chennai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N461||Oligospermia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Vithuvagai Chooranam  This Siddha Drug will be given as Oral route 1gm bd dose with milk for 48 days for the management of Aan maladu 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  50.00 Year(s)
Gender  Male 
Details  Male infertile
Oligospermia
Oligoasthenozoospermia
Patient willing to give specimen of semen, blood for investigation
Patient willing to give consent for the study 
 
ExclusionCriteria 
Details  Azoospermia
Teratospermia
Hydrocele
Varicocele
Diabetes mellitus
Klinefelter syndrome
Congenital disorders 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1)Increased sperm count.

Severe Oligospermia to Moderate Oligospermia
Mild Oligospermia or Normal Moderate Oligospermia to Mild Oligopermia or Normal.
Mild Oligospermia to Normal

2)Improved motility function.
Immotile to Non progressive motility or Progressive motility.
Non progressive motility to Progressive motility. 		 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in General wellbeing  12 months 
 
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 2 
Date of First Enrollment (India)   09/09/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  NIL

  6. For how long will this data be available start date provided 05-06-2025 and end date provided 31-12-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Infertility is one of the medical conditions that affect millions of people worldwide. It
is also a global problem in the field of reproductive health and is one of the major
contributors for the decline in birth rate.
Infertility is a clinical condition defined by the failure to achieve a clinical pregnancy in
12 or more months of regular unprotected sexual intercourse. In male reproductive
system, infertility is most commonly caused by the problems in ejaculation of semen,
absence or low level of sperm or abnormal shape(Morphology) and movement(Motility)
of the sperm.
According to the statistics collected from the World Health Organization (WHO), it
is estimated that around 60 to 80 million couples worldwide currently suffer from
infertility. Many couples assume that infertility is a female problem and is called a social
stigma, but in the general it is only 15% to 20%, but the male is responsible for 20 to
40%.In a World Health Organization multicenter study, 45% of infertile men were found
to have either Oligo-zoospermia or Azoospermia.
According to WHO’s 2010 guidelines, the qualities of Semen required for fertility
are:(1) Volume of Semen per ejaculation must be at least 1.5 ml (2) Sperm count must
be at least 15 million /ml (3) Number of Sperm in each ejaculation must be at least 39
million (4) 58% of Sperm per ejaculation must be alive (5) 40% of sperm must be
Motile (6) 30% of Sperm must have normal shape and structure. Oligospermia is
decrease in the sperm concentration in semen below 15 million sperm per milliliter
(WHO, 2010).
In Siddha system of Medicine, there are unique combination of medicines which
have a solution for MALE INFERTILTY. One such combination is VITHUVAGAI
CHOORANAM which is a classical Siddha Herbal formulation mentioned in
NOIGALUKKU SIDDHA PARIGAARAM, PAGE NO 300, for the treatment of Aan
Maladu (Male Infertility). The therapeutic efficacy of this Siddha formulation is so far
not evaluated scientifically, so the author tries to evaluate its efficacy in an open clinical
trial.
 
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