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CTRI Number  CTRI/2024/08/071813 [Registered on: 02/08/2024] Trial Registered Prospectively
Last Modified On: 26/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Siddha 
Study Design  Single Arm Study 
Public Title of Study   A Study to know the effect of Rasaganthi mezhugu (Internal) and Powthira kalimbu (External) for the management of Powthiram (fistula-in-ano)  
Scientific Title of Study   An open clinical trial to evaluate the effectiveness of Rasaganthi Mezhugu (Internal) and Powthira Kalimbu (External) in the management of Powthiram (fistula-in-ano) among patients attending Ayothidoss Pandithar Hospital,National Institute of Siddha. 
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 V Bharathi 
Designation  PG Scholar 
Affiliation  National Institute of Siddha 
Address  Room no 7/8 Department of Maruthuvam National institute of Siddha Tambaram Sanatorium Kancheepuram Tamilnadu India

Kancheepuram
TAMIL NADU
600047
India 
Phone  7540036688  
Fax    
Email  drrathivenkatbsms@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr H Nalini sofia 
Designation  Associate Professor 
Affiliation  National Institute of Siddha 
Address  Room no 7/8 Department of Maruthuvam National institute of Siddha Tambaram Sanatorium Kancheepuram Tamilnadu India

Kancheepuram
TAMIL NADU
600047
India 
Phone  8939899363  
Fax    
Email  drhnalinisofia@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr H Nalini sofia 
Designation  Associate Professor 
Affiliation  National Institute of Siddha 
Address  Room no 7/8 Department of Maruthuvam National institute of Siddha Tambaram Sanatorium Kancheepuram Tamilnadu India

Kancheepuram
TAMIL NADU
600047
India 
Phone  8939899363  
Fax    
Email  drhnalinisofia@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Siddha Tambaram Sanatorium chennai 47 India  
 
Primary Sponsor  
Name  National Institute of Siddha  
Address  Room no 7/8 Department of Maruthuvam National institute of Siddha Tambaram Sanatorium Kancheepuram 600047 Tamilnadu India  
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 V Bharathi  Ayothidoss Pandithar Hospital  Room no 7/8 Department of Maruthuvam National institute of siddha Tambaram Sanatorium Kancheepuram Tamilnadu India
Kancheepuram
TAMIL NADU 		 07540036688

drrathivenkatbsms@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  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 
Comparator Agent  nil  nil 
Intervention  Rasaganthi Mezhugu (Internal) and Powthira Kalimbu (External)  Internal medicine is a Compound Herbo mineral drug indicated to treat fistula in ano advised to intake 500mg twice a day for 96 days and External medicine of sufficient quantity is given in the form of kaarathiri once in 7 days for 90 days or till the tract heals whichever is earlier  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Pus, blood and watery discharge from perianal and anal region.
2.Fistula tract – ≤5 cm
3.patient who have low anal fistula.
4.Patient who are willing to undergo kaarathiri therapy.
5.Willing to give specimen of blood for investigation whenever required.
6.Willing to attend OPD or admission in IPD.
7.Willing to take photograph before and after treatment
8.Patient already presenting with MRI fistulogram ( Recent one month ) or willing to
get the MRI from recognized laboratory (based on St James University Hospital
MRI classification for fistula ).  
 
ExclusionCriteria 
Details  1.Tuberculosis (Genito urinary tract).
2.Hepatitis B & C.
3.Hemophilia and bleeding disorders.
4.Pregnancy & Lactation.
5.Uncontrolled diabetes.
6.K/H/O Coronary Heart Diseases and other cardiac ailments.
7.HIV, Syphilis.
8.K/H/O Crohn’s disease.
9.High anal fistula and complicated fistula.
Rectal prolapse.
10.K/H/O Rectal carcinoma.
11.K/H/O Ulcerative colitis 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Primary outcome will be assessed by Peri-anal Disease Activity Index (PDAI) and good
outcome of PDAI score becoming zero 		 96 days 
 
Secondary Outcome  
Outcome  TimePoints 
To measure the unit cutting time by using unit cutting time formula  90 days or till the tract heals whichever comes early 
 
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)   01/09/2024 
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 - 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 medicine which cure the diseases. Most of the medicines are aimed at maintaining and balancing three humours (Vadham, Pitham, Kabam). In Yugi Vaithiya Sinthamani, yugi classified the Powthiram disease into 8 types. These are Asana powthiram , Kodi powthiram, Pakka powthiram, Moola powthiram, Kiranthi powthiram, Mega powthiram ,Asana kandamalai powthiram, Sarakandamalai powthiaram. 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 Rasaganthi mezhugu (internal),which is described in Pulippani-500 and Powthira Kalimbu 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 tract .Fistula in-ano is one of the most common anorectal diseases. It is an epithelial lined tract connecting the anal canal to the perianal skin. Anal fistulas can have many causes but are most commonly the result of an anorectal abscess. According to Park’s classification it classified into 4 types (Inter-sphincteric, Trans-sphincteric, Supra-sphincteric, Extra-sphincteric). The symptoms are recurrent anal abscess, pain and swelling around anal region, bloody or foul- smell drainage (pus) from an opening around the anus, pain with bowel movement. 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 .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 Rasaganthi mezhugu (internal),which is described in Pulippani-500 and Powthira Kalimbu (external) which is described in Athmarakchamirtham ennum vaithiya saara sangiragam 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. Kaarathiri will be prepared by applying kalimbu to sterilised gauze.

OBJECTIVES 
 I. Primary objectives To evaluate the improvement of symptoms like pain, pus discharge, burning sensation, itching, induration , tenderness around the anus will be assessed by Perianal Disease Activity Index (PDAI) 
 II. Secondary objective To measure the unit cutting time accessed by, Unit cutting time = total number of days taken for cut through / Initial length of track in cm = ------days/cm

METHODOLOGY
A total of 20 diagnosed patients of Powthiram (fistula in ano) within the age limit of 20-60 years willing to participate in the study by signing the consent form will be enrolled in the study based on inclusion criteria. Patients with Tuberculosis (Genito urinary tract),Hepatitis B &C, Hemophilia and bleeding disorders, Pregnancy & Lactation, Uncontrolled diabetes, K/H/O Coronary Heart Diseases and other cardiac ailments, HIV, Syphilis, K/H/O Crohn’s disease, High anal fistula and complicated fistula, Rectal prolapse, K/H/O Rectal Carcinoma, K/H/O Ulcerative Colitis will be excluded

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, interim (Day- 48), and post treatment (Day 96)] 
 To measure the unit cutting time assessed by Unit cutting time = total no of days taken for cut through / initial length of the tract in cms = -----days / cm [Time points: baseline, interim (Day- 48), and post-treatment (Day 96)]

RESULTS AND DISCUSSION : The result will be statistically analysed and reported.
KEYWORDS: Rasaganthi mezhugu, Powthiram, Fistula in ano, Powthira kalimbu, Kaarathiri


 
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