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CTRI Number  CTRI/2013/12/004265 [Registered on: 31/12/2013] Trial Registered Prospectively
Last Modified On: 26/12/2013
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Siddha 
Study Design  Single Arm Study 
Public Title of Study   Clinical research of siddha medicine SUKKATHI CHOORANAM and INJI THYLAM in the treatment of‘KABHAPEENISAM’ (SINUSITIS) 
Scientific Title of Study   CLINICAL STUDY ‘KABHAPEENISAM’ (SINUSITIS)AND THE DRUG OF CHOICE IS SUKKATHI CHOORANAM(INTERNAL) and INJI THYLAM(EXTERNAL) . 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  V MANOPRIYA 
Designation  PG SCHOLAR 
Affiliation  NATIONAL INSTITUTE OF SIDDHA 
Address  DEPT.OF MARUTHUVAM NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM CHENNAI

Kancheepuram
TAMIL NADU
600047
India 
Phone  9791637927  
Fax  044-22381314  
Email  manopriyanis@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  PROF DR S MOHAN 
Designation  DEAN 
Affiliation  NATIONAL INSTITUTE OF SIDDHA 
Address  NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM CHENNAI

Kancheepuram
TAMIL NADU
600047
India 
Phone  044-22411611  
Fax  044-22381314  
Email  drmohan139@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR H NALINI SOFIA 
Designation  LECTURER 
Affiliation  NATIONAL INSTITUTE OF SIDDHA 
Address  DEPT.OF MARUTHUVAM NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM CHENNAI

Kancheepuram
TAMIL NADU
600047
India 
Phone  9677777677  
Fax  044-22381314  
Email  dr.h.nalinisofia@gmail.com  
 
Source of Monetary or Material Support  
AYOTHIDOSS PANDITHAR HOSPITAL 
 
Primary Sponsor  
Name  AYOTHIDOSS PANDITHAR HOSPITAL 
Address  NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM CHENNAI TAMILNADU INDIA 
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 V MANOPRIYA  AYOTHIDOSS PANDITHAR HOSPITAL  NATIONAL INSTUTUTE OF SIDDHA TAMBARAM SANATORIUM CHENNAI
Kancheepuram
TAMIL NADU 		 9791637927
044-22381314
manopriyanis@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  KABHA PEENISAM (SINUSITIS),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  SUKKATHI CHOORANAM (INTERNAL MEDICINE) WITH INJI THYLAM(EXTERNAL MEDICINE)  1.5 gm of Sukkathi chooranam will be administered orally twice a day along with cows ghee for a period of 24 days. With this treatment Inji thylam will be prescribed to take oil bath twice a week. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  • Age :18-50Yrs
• Sex – Both male & female
• The symptoms of pain in the face, purulent nasal discharge, and headache/heaviness of head, sneezing, fever, tooth ache, nasal block, and presence of any three symptoms will be taken as inclusion criteria.
•Patient willing to sign the informed consent stating that he/she will conscientiously stick to the treatment during 24 days but can opt out of the trial of his/her own conscious discretion.
•Patients who are willing for radiological investigation (X-ray for Paranasal sinuses) and provide blood, urine for lab investigation.
 
 
ExclusionCriteria 
Details  Bronchial asthma
Tuberculosis
Diabetes mellitus
Hypertension
Heart disease
Chronic obstructive pulmonary disease
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The outcome is mainly assessed by laboratory and clinical symptom scoring.  Pre study screening and after treatment 
 
Secondary Outcome  
Outcome  TimePoints 
Clinical assessments  Pre study screening and after treatment 
 
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 3 
Date of First Enrollment (India)   01/01/2014 
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="6"
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 and safety of SUKKATHI CHOORANAM in patients with KABHA PEENISAM (SINUSITIS).In this trial 40 sinusitis patients will be recruited and the trial drug will be administered 1.5 gm twice a day along with cow’s ghee for a period of 24 days. During this trial period all the study related data will be recorded and documented in a separate trial master file for each patients.During the trial period if any AE/SAE/SUSAR will be noticed and referred to pharmacovigilance dept.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 and efficacy parameters will be recorded in the CRF. After completion of the trial all the study related data will be analysed statistically .The out come of this trial will be published in Indian Journal of Medical Research.

 
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