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CTRI Number  CTRI/2017/05/008584 [Registered on: 17/05/2017] Trial Registered Prospectively
Last Modified On: 16/05/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Siddha 
Study Design  Single Arm Study 
Public Title of Study   Pre clinical and clinical study of Kukkil chooranam(Internal) and Thuvara ennai(External) in the treatment of Varicose ulcer(Nalavibatha viranam) 
Scientific Title of Study   Preclinical and clinical study of siddha drug "kukkil chooranam"(Internal medicine) and "thuvara ennai"(External medicine) in the treatment of pun (Naalavibatha pun- varicose ulcer) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mrs V Mahalakshmi 
Designation  Lecturer 
Affiliation  National Institute of Siddha 
Address  Department of Sirappu Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai-600047

Kancheepuram
TAMIL NADU
600047
India 
Phone  9444519975  
Fax    
Email  rvmahalakshmi85@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mrs V Mahalakshmi 
Designation  Lecturer 
Affiliation  National Institute of Siddha 
Address  Department of Sirappu Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai-600047


TAMIL NADU
600047
India 
Phone  9444519975  
Fax    
Email  rvmahalakshmi85@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mrs V Mahalakshmi 
Designation  Lecturer 
Affiliation  National Institute of Siddha 
Address  Department of Sirappu Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai-600047


TAMIL NADU
600047
India 
Phone  9444519975  
Fax    
Email  rvmahalakshmi85@gmail.com  
 
Source of Monetary or Material Support  
Ayothidass pandithar hospital, National institute of siddha 
 
Primary Sponsor  
Name  NATIONAL INSTITUTE OF SIDDHA 
Address  NATIONAL INSTITUTE OF SIDDHA, TAMBARAM SANATORIUM, CHENNAI-47 
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 C Sasikala  Ayothidass pandithar hospital  OPD no 3 and IPD, Department of sirappu maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai 600047.
Kancheepuram
TAMIL NADU 
7200600640
-
sasiikala91@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  Having varicose ulcers in legs,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  External Medicine - Thuvara Ennai  Thuvara ennai is Oil based external Medicine - Quantity sufficient (approximately 25 Milli liter) for external application on the ulcers once a day for totally 48 days 
Intervention  Internal Medicine - Kukkil Chooranam  Kukkil Chooranam as a internal medicine by Oral route, - 01 grams, twice a day with honey and after meals for totally 48 days 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Presence of ulcers with varicose veins
With or without Pain, Itching, Edema, Fibrinous exudates in the lesions
2.Hyper pigmentation
3.Eczema around the ulcer
4.Inflammation
5.Induration
 
 
ExclusionCriteria 
Details  1.Diabetes Mellitus
2.Hansen’s disease
3.Diabetic ulcer
4.Gangrene
5.Tuberculous ulcer
6.Any other systemic illness
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction of varicose ulcer is assessed by Venous clinical severity score (VCSS) and reduction of associated symptoms of Varicose ulcer  every 7 days for 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction of associated symptoms of Varicose ulcer  03 months 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   25/05/2017 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   It is a single non randomized, open label trial to determine the efficacy of kukkil chooranam(Internal) prepared by herbal and mineral constituents and thuvara ennai(External) in patients with nalavibatha pun9Varicose ulcer). In this trial 40 patients will be recruited and the trial drug will be administered 1gm twice a day with honey for a period of 48 days. during the trial period if any AE/SAE/SUSAR will be noticed and refered to pharmacovigilance in NIS and further management will also be given in NIS OPD/IPD. The entire trial will be monitored by the research monitoring committee of NIS. During this trial all the safety efficacy parameters will be recorded in the CRF. After completion of the trial all the study related data will be analysed statistically. The outcome of this trial will be published in India jurnal of Medical research.   
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