FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/03/083184 [Registered on: 24/03/2025] Trial Registered Prospectively
Last Modified On: 21/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Siddha 
Study Design  Single Arm Study 
Public Title of Study   A Clincal trial on Gowri Chinthamani Chendooram and Pachai ennai for Powthiram (Fistula-in-Ano) 
Scientific Title of Study   A Clinical trial to determine the effectiveness of Gowri Chinthamani Chendooram (Internal) and Pachai ennai (External) in the management of Powthiram (fistula-in-ano) among patients attending Ayothidoss pandithar Hospital,National Institute of Siddha. 
Trial Acronym  Anal fistula 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Abirami S 
Designation  Pg scholar 
Affiliation  National Institute Of Siddha 
Address  Room no 7/8,Department of maruthuvam,National Institute Of Siddha,Tambaram Sanatorium,Chennai.
Room no 7/8,Department of maruthuvam,National Institute Of Siddha,Tambaram Sanatorium,Chennai.
Chennai
TAMIL NADU
600047
India 
Phone  9597350346  
Fax    
Email  abiramisammu@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr H Vetha Merlin Kumari 
Designation  Professor 
Affiliation  National Institute Of Siddha 
Address  Room no 7/8,Department of maruthuvam,National Institute Of Siddha,Tambaram Sanatorium,Chennai.
Room no 7/8,Department of maruthuvam,National Institute Of Siddha,Tambaram Sanatorium,Chennai.
Chennai
TAMIL NADU
600047
India 
Phone  9894782366  
Fax    
Email  dr.vetha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vetha Merlin Kumari 
Designation  Professor 
Affiliation  National Institute Of Siddha 
Address  Room no 7/8,Department of maruthuvam,National Institute Of Siddha,Tambaram Sanatorium,Chennai.
Room no 7/8,Department of maruthuvam,National Institute Of Siddha,Tambaram Sanatorium,Chennai.
Chennai
TAMIL NADU
600047
India 
Phone  9894782366  
Fax    
Email  dr.vetha@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Siddha,Tambaram Sanatorium,Chennai-47 
 
Primary Sponsor  
Name  National Institute of Siddha 
Address  Room no 7/8,Department of Maruthuvam,National Institute of siddha,Tambaram Sanatorium,Chennai-47. 
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 Abirami S  National institute of Siddha  Room no7/8, Department of Maruthuvam,National Institute of Siddha,Tambaram Sanatorium,Chennai-47.
Chennai
TAMIL NADU 
9597350346

abiramisammu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K603||Anal fistula,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Gowri Chinthamani Chendooram(Internal) and Pachai ennai(External)  200 mg of Gowri Chinthamani Chendooram along with adjuvant~1.5 g(Kattukarunakilangu podi+Kadukkai podi+Sukku podi+Thippili podi)with honey Bd,after food for 48 days. Pachai ennai will be applied as Thiri.Thiri will be replaced 3 days once. 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Day(s)
Age To  60.00 Day(s)
Gender  Both 
Details  Participants having the clinical features of the following
Pain and swelling in the perianal region
Pus or blood discharge from perianal and anal region
Skin irritation
Perianal abscess
Fistula tract length less than 5 cm.
According to St James University Hospital Classification of Perianal Fistula,Grade I and Grade II.
Participants willing to undergo Kaarathiri therapy.
Participants already presenting with MRI Fistulogram or willing to undergo the MRI
from recognized laboratory.  
 
ExclusionCriteria 
Details  Infectious risk category [Tuberculosis (Genitourinary tract),Hepatitis B & C,AIDS,Syphilis]
Hemophilia and bleeding disorders.
Pregnancy and lactation.
High anal fistula and Complicated fistula. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Outcome will be assessed by Peri-anal Disease Activity Index(PDAI) and good outcome of PDAI score becoming zero[Timepoints:Baseline and Post treatment (Day 48)]  18 months 
 
Secondary Outcome  
Outcome  TimePoints 
Outcome will be assessed by Unit Cutting time,
Unit cutting time=Total no f days taken for cut through/Initial length of the tract in cms=-----days/cms[Baseline and Post treatment (Day48)] 
18 months 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   08/04/2025 
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="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 - NO
Brief Summary  

BACKGROUND:

Siddha system is one of the ancient systems of medicine, which originated from south India. According to Siddha medicine, diseases were classified into 4448 types based on Mukkutram (Vadham, Pitham, Kabam). Siddha system has a vast Internal and External medicines which cure the diseases. Most of the medicines are aimed at maintaining and balancing three humours (Vadham, Pitham, Kabam). In Yugi Vaithiya chinthamani, yugi classified the Powthiram disease into 8 types. Powthiram is characterized as a sinus present inside or outside anus or urethra. .The risk factors of powthiram in siddha literatures are, prolonged sitting, consuming spicy foods, horse mount, elephant climb, foods which cause piles. The common symptoms are redness, itching, and pain around the anus region, bloody or pus discharge from the fistula tract. According to Park’s classification it is classified into 4 types (Inter-sphincteric, Trans-sphincteric, Supra-sphincteric, Extra-sphincteric). The prevalence is greater in men than women, with a rate of 12.3 cases per 1,00,000 and 5.6 cases per 1,00,000 respectively. The average age at diagnosis is 38 years, with most occurring between 20 to 40 years of age.The goals in the treatment of an anal fistula are to eliminate the primary fistula opening, any associated tracts, or any secondary openings without change in incontinence. The simplest anal fistula are treated using fistulotomy with a recurrences and the other morbidities.Complex fistula management poses increased risk of a change in incontinence and the higher chances of recurrences which forced surgeons to search for a better option.Various modalities like cutting seton, Endorectal advancement flap, fibrin glue injection, fistula plug, Ligation of intersphincteric Fistula Tract (LIFT) are being tried to overcome the hardship faced by the patients. Siddha system of medicine treats the disease in more cost effective and palatable way, when compared with modern medicine. The formulation selected for this dissertation study is Gowri chinthamani chendooram (internal), which is described in Agasthiyar vaithiya kaviyam- 1500 and Pachai ennai (external) which is described in The pharmacopoeia of Siddha research medicines for Powthiram (fistula- in- ano).So, I have chosen this medicine for management of Powthiram. Kaarathiri is the best procedure for treatment of chronic ulcers, abscess and fistula-in-ano.Thiri will be prepared by applying Pachai ennai to sterilised gauze.

OBJECTIVES:

Primary objective:To determine the effectiveness of Gowri chinthamani chendooram (Internal) and Pachai ennai (External) in the management of Powthiram through Perianal Disease Activity Index (PDAI) score.

Secondary objective: To measure the unit cutting time assessed by, Unit cutting time = total number of days taken for cut through / Initial length of track in cms = ------days / cm.

STUDY DESIGN:

This is an interventional study  of Non Randomized sampling which will be carried out for 18 months in participants with Fistula-in-Ano reporting to OPD of Ayothidoss Pandithar Hospital, National Institute of Siddha,Chennai-47 with 20 Participants as Sample size.Participants with age from 18 to 60  years of both age  and with Fistula-in-ano  will be included.

OUTCOME OF THE STUDY:

Primary outcome will be assessed by Peri-anal Disease Activity Index (PDAI) and good outcome of PDAI score becoming zero, [Time points: baseline and post-treatment (Day 48)]

Outcome will be assessed by unit cutting time, Unit cutting time = total no of days taken for cut through / initial length of the tract in cms = -----days / cm [Time points: baseline and post-treatment (Day 48)].

RESULTS AND DISCUSSION:

The results will be statistically analysed and reported.

KEYWORDS:

Powthiram, Gowri Chinthamani Chendooram, Pachai ennai, Fistula-in-Ano.

 

 
Close