FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/01/061252 [Registered on: 09/01/2024] Trial Registered Prospectively
Last Modified On: 04/01/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Siddha 
Study Design  Other 
Public Title of Study   A Clinical trial in siddha for fistula with Panchapadana Chenduram and Meni thylam  
Scientific Title of Study   A Pilot Clinical trial to determine the Efficacy of Siddha treatment with Panchapadana Chenduram and Meni thylam in the Management of Powthiram(Fistula in ano) 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Dr G J Christian 
Designation  Professor 
Affiliation  National Institute of Siddha 
Address  Room.no 20,21 NoiNaadal Department National Institute of Siddha Tambaram Sanatorium Chennai

Chennai
TAMIL NADU
600047
India 
Phone  9962545930  
Fax    
Email  christianvijila@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr M Ramamoorthy 
Designation  Associate Professor 
Affiliation  National Institute of Siddha 
Address  Room no 20,21 NoiNaadal Department National Institute of Siddha Tambaram Sanatorium Chennai

Chennai
TAMIL NADU
600047
India 
Phone  9443178112  
Fax    
Email  ramsnis@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr K Jeyaradha 
Designation  PG Scholar 
Affiliation  National Institute of Siddha 
Address  Room No 20 21,NoiNaadal Department National Institute of Siddha Tambaram Sanatorium Chennai

Chennai
TAMIL NADU
600047
India 
Phone  6380944859  
Fax    
Email  drjeyaradhakandhaiah@gmail.com  
 
Source of Monetary or Material Support  
Ayothidoss Pandithar Hospital National Institute of Siddha Chennai 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [nil] 
 
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 
DRGJCHRISTIAN  Ayothidoss Pandithar Hospital  Room No 20 21 Noinaadal Departemt National Institute of Siddha
Chennai
TAMIL NADU 		 9962545930

christianvijila@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  Panchapasana chenduram Meni thylam   Panchapasana chenduram 65 mg bd with palm jaggery and milk Meni thylam 5-10 ml HS warm water 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patient who will fulfil following criteria will be included in this study:
2. Age: 18 to 60 years.
3. Patients diagnosed with the condition of low anal fistula having single tract of length not more than
8 cm
4. Fistula patients of less than 3 years duration
5. Willingness of the patient to give blood and urine samples and cooperate by strictly complying with
the medical advice of the research team.
6. Patients who had not undergone previous surgery for fistula 
 
ExclusionCriteria 
Details  H/o Tuberculosis
ï‚·Uncontrolled metabolic disorders
ï‚· H/o Hepatitis B & C.
ï‚· H/o Haemophilia and bleeding disorders.
ï‚· H/o Pregnancy & Lactation.
ï‚· H/o Uncontrolled diabetes
ï‚· H/o coronary heart diseases and other cardiac ailments.
ï‚· H/o AIDS, Syphilis.
 H/o Crohn’s disease.
ï‚· High anal fistula and complicated fistula
ï‚· H/o Rectal prolapse
ï‚· H/o rectal carcinoma. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Number of patients achieved a Zero score of Peri Anal Disease Activity
Index (PDAI).
 		 90 days 
 
Secondary Outcome  
Outcome  TimePoints 
Duration taken for healing will be analyzed and described with respect
to the length of the tract and duration of the condition prior to the
intervention. 		 90 days 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   02/02/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
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  
Fistula in ano is a common surgical anorectal anomaly; it is notorious due to its chronicity,recurrences, and frequent exacerbations. A study conducted among the Indian rural population
estimated the incidence of low anal fistula around 8.6 per 1 lakh population with male to female ratio as 11.2:1.The disease ischaracterized by one or more external openings in the perianal region with an apparent internal opening anywhere in the anorectal mucosa. Pus discharge associated with mild to severe pain will be thepresenting feature.The goals in the treatment of an anal fistula are to eliminate the primary fistula opening,any associated tracts, or any secondary openings without a change in continence.
The simplest analfistulae are treated using fistulotomy with a high rate of recurrences and other morbidities. Complexfistulae management poses increased risk of a change in continence and higher chances of recurrenceswhich forced the surgeons to search for a better option.Various modalities like cutting seton,advancement flap, fibrin glue injection, fistula plug,ligationofintersphincteric fistula tract (LIFT), orBioLIFT (LIFT technique with a variation) are being tried to overcome the hardship faced by the
patients.Hence this pilot study is put forward to assess the therapeutic efficacy of Pancha paadanachendooram and Meni thylam which are indicated for Powthiram (Fistula in ano) condition as perclassical Siddha Literature in management of fistula in ano.
 
Close