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CTRI Number  CTRI/2024/07/070363 [Registered on: 10/07/2024] 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   Adathodai Girutham for Piles 
Scientific Title of Study   Single Centric Non-Randomized Open Clinical Trial Phase II in “Mulai Moolam”(Internal Haemorrhoids) with Siddha Medicine “Adathodai Girutham” among 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  Bharath R 
Designation  PG Scholar 
Affiliation  Government Siddha Medical College, Chennai. 
Address  Room No:1, Post Graduate Department of Podhu Maruthuvam, Government Siddha Medical College,Arumbakkam,Chennai.

Chennai
TAMIL NADU
600106
India 
Phone  8525033471  
Fax    
Email  drbharathravi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sasirekha R 
Designation  Lecturer  
Affiliation  Government Siddha Medical College, Chennai. 
Address  Room No:1, Post Graduate Department of Podhu Maruthuvam, Government Siddha Medical College,Arumbakkam,Chennai.

Chennai
TAMIL NADU
600106
India 
Phone  9444832728  
Fax    
Email  sasirekha.siddha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Bharath R 
Designation  PG Scholar 
Affiliation  Government Siddha Medical College, Chennai. 
Address  Room No:1, Post Graduate Department of Podhu Maruthuvam, Government Siddha Medical College,Arumbakkam,Chennai.

Chennai
TAMIL NADU
600106
India 
Phone  8525033471  
Fax    
Email  drbharathravi@gmail.com  
 
Source of Monetary or Material Support  
Government Siddha Medical College, Arumbakkam, Chennai - 600106, Tamilnadu, India. 
 
Primary Sponsor  
Name  Dr Bharath R 
Address  Post Graduate Department of Podhu Maruthuvam, Government Siddha Medical College,Arumbakkam,Chennai. 
Type of Sponsor  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 Bharath R  Government Siddha Medical College  Room No S1, Government Siddha Medical College, Arumbakkam, Chennai.
Chennai
TAMIL NADU 
8525033471

drbharathravi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical 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: K641||Second degree hemorrhoids,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Adathodai Girutham  This Siddha drug will be given as 4ml, BD dose for 48 days for the management of Internal Haemorrhoids. 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age 20 to 60 years of both gender
1 degree and 2 degree Internal Haemorrhoids
Constipation
Pruritis Ani
Bleeding per rectum
Patients willing to give specimen of blood for the
investigation 
 
ExclusionCriteria 
Details  External Haemorrhoids
3 degree and 4 degree Internal Haemorrhoids
Fissure in ano
Fistula in ano
Pregnant and Lactating women
Rectal prolapse 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary Outcome will be mainly assessed by reduction in clinical symptoms and by comparing the PNR bleed scale and HSS scale before and after treatment.  3 Months 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary Outcome will be mainly assessed by reduction in clinical symptoms and by comparing the PNR bleed scale and HSS scale before and after treatment.  48 Days 
 
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)   13/09/2024 
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="0"
Months="6"
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 11-06-2025 and end date provided 13-04-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
The word ‘Haemorrhoids’ derived from Greek word ‘Haima’(bleed) and
‘Rhoos’(flowing) means bleeding. The word ‘Pile’ derived from Latin word ‘Pila’ means Ball.
Haemorrhoids arise from the congestion of the internal and / or external venous plexus around the anal canal. They are extremely common in adults. 
Varicosities of the veins of the anal canal are known as haemorrhoids. It may be internal or external depending on the position of the varicosity. If it is above the Hilton’s Line it is called ’ Internal haemorrhoid’ and if it is below the Hilton’s Line it is called ’External haemorrhoid’. So internal haemorrhoid is covered by mucous membrane whereas the external haemorrhoid is covered with skin.

In India approximately 40,723,288 people are reported to have haemorrhoids. 1million new cases are reported annually, it is estimated that 50-85% 0f people around the world have haemorrhoids and in India 75% of the population is estimated. Current statistics suggest that almost half of people in their fifties have piles.

In classical siddha literature KANNUSAMI PARAMBARAI VAITHIYAM, the siddha medicine formulation ADATHODAI GIRUTHAM is indicated for the MOOLAM. It will be therapeutically effective and it also cost effective and reliable for a long duration treatment. So, the author decides to evaluate its efficacy in an open clinical trial.
 
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