FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/06/068356 [Registered on: 05/06/2024] Trial Registered Prospectively
Last Modified On: 04/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Siddha 
Study Design  Single Arm Study 
Public Title of Study   An open lab effectiveness of Effectiveness of KOWSIGAR KULAMBU PUGAI[EXTERNAL THERAPY] in the management of VELI MOOLAM[EXTERNAL HAEMORRHOID] 
Scientific Title of Study   An open labelled non randomized phaseII Clinical trial to evaluate the effectiveness of KOWSIGAR KULAMBU PUGAI[EXTERNALTHERAPY] in the management of VELI MOOLAM[EXTERNAL HAEMORRHOID] 
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 S DHEIVANI 
Designation  Pg scholar 
Affiliation  Government siddha medical college and hospital palayamkottai 
Address  Second year pg scholar department of puramaruthuvam government siddha medical college and hospital palayamkottai tirunelveli, India

Tirunelveli
TAMIL NADU
627002
India 
Phone  6385429474  
Fax    
Email  dheivanisudappan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr s sujatha MD s  
Designation  Associate professor and hod  
Affiliation  Government siddha medical college and hospital palayamkottai 
Address  Government siddha medical college and hospital palayamkottai tirunelveli

Tirunelveli
TAMIL NADU
627002
India 
Phone  9442331462  
Fax    
Email  sujatharajasekar66@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr s sujatha MD s  
Designation  Associate professor and hod  
Affiliation  Government siddha medical college and hospital palayamkottai 
Address  Department of pura maruthuvam Government siddha medical college and hospital palayamkottai tirunelveli

Tirunelveli
TAMIL NADU
627002
India 
Phone  9442331462  
Fax    
Email  sujatharajasekar66@gmail.com  
 
Source of Monetary or Material Support  
OPD and IPD facilities and central Library of government siddha medical college and hospital, Palayamkottai, Thirunelaveli 627002 
 
Primary Sponsor  
Name  Dr S Dheivani 
Address  Second year pg scholar department of puramaruthuvam government siddha medical college and hospital palayamkottai tirunelveli, 627002,India 
Type of Sponsor  Other [Self] 
 
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 S dheivani  Government siddha medical college and hospital  Pg department of puramaruthuvam government siddha medical college and hospital palayamkottai tirunelveli
Tirunelveli
TAMIL NADU 		 6385429474

dheivanisudappan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee , government siddha medical college palayamkottai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K644||Residual hemorrhoidal skin tags,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Kowsikar kulambu pugai  10to15mins duration of pugai an external therapy for 7 days 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients having the symptoms of pain, lump hanging down outside of the anus, soreness, redness,bleeding during passing stools, swelling and itching around the anal orifice.
Patients who is willing to undergo necessary investigations.
Willing for admission in IPD for 7 days or willing to attend OPD regularly.
Patients who are willing to participate in this study with knowledge of potential risks and who are willing to sign the informed consent.
Patients who are willing to take external therapy only

 
 
ExclusionCriteria 
Details  Fistula in ano
Anal fissure
Colorectal cancer
Ulcerative colitis
Rectal prolapse
Pregnancy
Lactating mothers
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction of pain, swelling, itching, soreness, bleeding and the lump size is assessed by using pain assessment tool and clinical assessments.   7 days 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   17/06/2024 
Date of Study Completion (India) 20/08/2025 
Date of First Enrollment (Global)  17/06/2024 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
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   This study is an open labelled non randomized phase II clinical  trial to evaluate the effectiveness of kowsikar kulambu pugai (external therapy) in the management of velimoolam(external haemorrhoid).the trial drug will be an external application of PUGAI for 7days in 40patients. The periods of 24months will be carried out in government siddha medical college and hospital palayamkottai tirunelveli 627002.The outcome will be an external therapy in kowsikar kulambu pugai towards the management of velimoolam(external piles) and expect the patients to be relieved from the symptoms. In case of any adverse events is noticed and it will be referred to pharmacovigilance department. Further management of patients will be given OPD patients.  
Close