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CTRI Number  CTRI/2024/10/074984 [Registered on: 09/10/2024] Trial Registered Prospectively
Last Modified On: 24/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   To evaluate the effect of Agnikarma with guda in Trigger finger. 
Scientific Title of Study   A clinical trial to evaluate the effect of Agnikarma with guda in Trigger finger. 
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 Aiswarya K 
Designation  First year PG scholar 
Affiliation  Government Ayurveda college Thiruvananthapuram 
Address  Department of Salyatantra Government Ayurveda college Thiruvananthapuram

Thiruvananthapuram
KERALA
695001
India 
Phone  9061800378  
Fax    
Email  aiswaryarameshank@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Aneesh S 
Designation  Associate Professor 
Affiliation  Government Ayurveda college Thiruvananthapuram, Kerala  
Address  Department of Salyatantra Government Ayurveda college Thiruvananthapuram

Thiruvananthapuram
KERALA
695001
India 
Phone  8281097953  
Fax    
Email  draneeshkerala@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Aiswarya K 
Designation  First year PG scholar 
Affiliation  Government Ayurveda college Thiruvananthapuram 
Address  Department of Salyatantra Government Ayurveda college Thiruvananthapuram

Thiruvananthapuram
KERALA
695001
India 
Phone  9061800378  
Fax    
Email  aiswaryarameshank@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurveda College Thiruvananthapuram Kerala 695001 
 
Primary Sponsor  
Name  Government Ayurveda College Thiruvananthapuram 
Address  Government Ayurveda college Thiruvananthapuram Pin code 695001  
Type of Sponsor  Other [Government Ayurveda college] 
 
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 Aiswarya k  Government Ayurveda College Thiruvananthapuram  Department of Salya Tantra, OP Division room no 3 Thiruvananthapuram.
Thiruvananthapuram
KERALA 		 9061800378

aiswaryarameshank@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL COMMITTEE FOR ETHICS IN RESEARCH GOVERNMENT AYURVEDA COLLEGE THIRUVANANTHAPURAM  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M653||Trigger finger. Ayurveda Condition: SNAYUGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: Susrutha samhita sootrastana, Procedure details: All prerequisites of agni karma will be collected.The participant is made to sit comfortably with palm extended & the tender points of affected digit & palm will be marked.Required amount of guda & sufficient quantity of water is taken in a sterile dish. It will be heated over the stove till it attain syrup consistency (130ºC -140ºC), & its temperature is measured with a probe thermometer. One drop of guda will be dropped in each marked site by a borosil dropper. On cooling it will be wiped off carefully using sterile cotton. Agnikarma with guda in bindu type dahana visesha will be done over the site as a one-time procedure.Assessment will be done on 0 th day before & after procedure,and in the follow up period on 7 th,14 th, & 21 st day.Total study duration is 22 days & treatment period is one day)
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Participants satisfying diagnostic criteria of trigger finger irrespective of age.
Age group 30 to 70 years.
Participants with informed consent.
 
 
ExclusionCriteria 
Details  Participants contraindicated for Agnikarma as per classics.
Presence of wounds, infection and callosity in the area where procedure is planned.
Known case of Fracture of affected hand
Trigger finger involving more than one digits in one hand.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reducing signs and symptoms of trigger finger.
Improving Quinell grading in affected digit  		 Assessment will be done on 0th day before and after treatment and on 7th ,14th and 21st day 
 
Secondary Outcome  
Outcome  TimePoints 
Reducing pain (assessed by VAS scale)and tenderness(grading) in affected digit  Assessment will be done on 0th day before and after treatment and on 7th ,14th and 21st day 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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   N/A 
Date of First Enrollment (India)   21/10/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   The above study deals with assessing the effect of agnikarma with guda in trigger finger. Evaluation is made on subjective criterias which include  Quinnell grading of trigger finger and pain(assessed by VAS scale) and objective criteria tenderness(assessed by grading) 
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