FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/02/080306 [Registered on: 10/02/2025] Trial Registered Prospectively
Last Modified On: 10/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Siddha 
Study Design  Single Arm Study 
Public Title of Study   Leech therapy for gouty arthritis 
Scientific Title of Study   An open single arm clinical trial to determine the therapeutic effect of Attai vidal (Leech therapy) in the management of Narithalai Vaatham (Gouty Arthritis)  
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 A ANBARASI 
Designation  PG SCHOLAR 
Affiliation  National Institute of Siddha 
Address  Department of Pura maruthuvam National Institute of Siddha Tambaram sanatorium Chennai

Chennai
TAMIL NADU
600047
India 
Phone  9488173056  
Fax    
Email  anbuasok04@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrDPERIYASAMI D 
Designation  Associate professor  
Affiliation  National Institute of Siddha 
Address  Department of Pura maruthuvam National Institute of Siddha,Tambaram Sanatorium,Chennai

Chennai
TAMIL NADU
600047
India 
Phone  7358481734  
Fax    
Email  sami2011nis@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr PERIYASAMI D 
Designation  Associate professor  
Affiliation  National Institute of Siddha 
Address  Department of Pura maruthuvam National Institute of Siddha,Tambaram Sanatorium,Chennai

Chennai
TAMIL NADU
600047
India 
Phone  7358481734  
Fax    
Email  sami2011nis@gmail.com  
 
Source of Monetary or Material Support  
National Institute of siddha Tambaran sanatorium Chennai-600047 
 
Primary Sponsor  
Name  National Institute of Siddha 
Address  Tambaram sanatorium Chennai 600047 
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 
DrAnbarasi  National Institute of Siddha  Tambaram sanatorium Chennai-600047
Chennai
TAMIL NADU 		 9488173046

anbuasok04@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, National Institute of Siddha  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M109||Gout, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Leech  Leech therapy will be done for 10 days. 4-5 sittings will be done 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  • Age 30-65 years
• All genders.
• Having classical symptoms of gout- development of maximal inflammation within one day, joint redness, pain, hyperuricemia, suspected tophus, attack of monoarticular arthritis, unilateral attack involving tarsal joint or first metatarsophalangeal joint, more than one attack of acute arthritis and subcortical cyst without erosions (presence of 6 or more findings will be included in the study)
 
 
ExclusionCriteria 
Details  Participants with h/o uncontrolled Diabetes and Hypertension
Participants with any bleeding abnormality while taking BT, CT.
Immunocompromised patients such as AIDS, Cancer, SLE.
• Pregnancy and lactation
• Psychiatric illness
• Septic arthritis, cellulitis, pseudo gout, and trauma.
• Participants with anemia
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The outcome of the study may reveal the therapeutic effect of Attaividal (Leech therapy) in the management of Narithalai vatham (Gouty arthritis) assessing with the Visual Analogue Scale.A) Range of the score:
0 No pain
1-3 occasionally pain
4-6 Moderate pain
7-10 Severe pain
OUTCOME OF THE SCORE:
0 Good improvement
1-3 Moderate improvement
4-6 Mild improvement
7-10 No improvement
I. VISUAL ANALOG SCALE:



 		 Baseline, each week until 8 week 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in quality of life
 		 Baseline, each week until 8 weeks 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "15"
Final Enrollment numbers achieved (India)="15" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   25/02/2025 
Date of Study Completion (India) 05/05/2026 
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)   Completed 
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   OBJECTIVES:
To determine the therapeutic effect of leech therapy in the management of
Narithalai vatham (Gouty arthritis)
To evaluate the improvement of clinical signs and symptoms of Narithalai
vatham (Gouty arthritis) participants before and after treatment of leech
application.
To study the Siddha basic principles towards effect of Leech therapy.
METHODOLOGY:
 STUDY DESIGN : An open single arm clinical trial
 STUDY TYPE : Interventional study
 STUDY PLACE : Ayothidoss Pandithar Hospital,National Institute of Siddha,
 Tambaram Sanatorium, Chennai-47.
 STUDY SIZE : 20 participants
 STUDY PERIOD : 18 months
 STUDY INTERVENTION : Attaividal
INCLUSION CRITERIA:
Age 20-65 years
 All genders.
Having classical symptoms of gout- intense pain, tenderness, swelling, redness and
warmth and limitation of movements

EXCLUSION CRITERIA:
 Participants with h/o uncontrolled Diabetes and Hypertension
Participants of bleeding disorders such as hemophilia, platelet disorder, capillary
bleeding and severe anemia
Immunocompromised patients such as AIDS, Cancer, SLE.
Pregnancy and lactation
 Psychiatric illness
WITHDRAWAL CRITERIA:
 Intolerance to leech therapy and development of any serious adverse reactions during
this trial Period clinical ASSESSMENT:
 The classical presentation is with an acute mono arthritis, which affects the first
metatarsal phalangeal joint. other common sites are ankle, midfoot, knee, small joints
of hands, wrist and elbow.
Severe pain, swelling and warmth in thew affected joints.
Affected joints are warm, red and swollen.
 Mild fever may be present
Tophi may be present in chronic, severe disease.OUTCOME:
 The outcome of the study may reveal the therapeutic effect of Attaividal (Leech therapy) in
the management of Narithalai vatham (Gouty arthritis) assessing with the Visual Analogue
 
Close