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CTRI Number  CTRI/2021/02/031206 [Registered on: 11/02/2021] Trial Registered Prospectively
Last Modified On: 10/02/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Siddha 
Study Design  Randomized, Crossover Trial 
Public Title of Study   A study to evaluate the Bio-enhancing activity of Siddha drug Thirikaduku Chooranam along with Anti- Tuberculosis drugs among the Pulmonary Tuberculosis patients. 
Scientific Title of Study   A simple randomized Cross-Over study to evaluate the Bio-enhancing activity of Siddha drug Thirikaduku Chooranam on the First line Anti- Tuberculosis drugs among the Category-1 Pulmonary Tuberculosis patients. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr K Nandhagopal 
Designation  Consultant Siddha 
Affiliation  Siddha Clinical Research Unit. 
Address  Siddha Clinical Research Unit Sri Venkateswara Institute of Medical Sciences Campus Alipiri Road Tirupati
Siddha Clinical Research Unit Sri Venkateswara Institute of Medical Sciences Campus Alipiri Road Tirupati
Chittoor
ANDHRA PRADESH
517507
India 
Phone  8281417248  
Fax    
Email  drnandhagopalsiddha@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr K Nandhagopal 
Designation  Consultant Siddha 
Affiliation  Siddha Clinical Research Unit. 
Address  Siddha Clinical Research Unit Sri Venkateswara Institute of Medical Sciences Campus Alipiri Road Tirupati
Siddha Clinical Research Unit Sri Venkateswara Institute of Medical Sciences Campus Alipiri Road Tirupati
Chittoor
ANDHRA PRADESH
517507
India 
Phone  8281417248  
Fax    
Email  drnandhagopalsiddha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr K Nandhagopal 
Designation  Consultant Siddha 
Affiliation  Siddha Clinical Research Unit. 
Address  Siddha Clinical Research Unit Sri Venkateswara Institute of Medical Sciences Campus Alipiri Road Tirupati
Siddha Clinical Research Unit Sri Venkateswara Institute of Medical Sciences Campus Alipiri Road Tirupati
Chittoor
ANDHRA PRADESH
517507
India 
Phone  8281417248  
Fax    
Email  drnandhagopalsiddha@gmail.com  
 
Source of Monetary or Material Support  
Central Council for Research in Siddha Ministry of AYUSH Govt of INDIA Chennai 
 
Primary Sponsor  
Name  The Director General 
Address  Central Council for Research in Siddha Ministry of AYUSH Govt of INDIA Chennai 
Type of Sponsor  Research institution 
 
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 K Nandhagopal  General OPD, Clinical Department, Siddha Clinical Research Unit, Tirupati  SVIMS Campus Alipiri Road Tirupati
Chittoor
ANDHRA PRADESH 
8281417248

drnandhagopalsiddha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Siddha Clinical Research Unit Tirupati IHEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J988||Other specified respiratory disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  DOTS FIRST LINE TREATMENT combination of 4 drugs Isoniazid  10-15 mg/kg for 28 days  
Comparator Agent  Ethambutol   30 mg/kg once daily for 28 days. 
Comparator Agent  Pyrazinamide  35mg/kg once a day for 28 days 
Comparator Agent  Rifampicin   10mg/kg, once a day for 28 days 
Intervention  Thirikatuku Chooranam  2 gm, Twice Daily for 28 days. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients under DOTS ( Anti- Tuberculosis) Therapy
Category 1 for new smear positive patients with pulmonary TB.
 
 
ExclusionCriteria 
Details  h/o Throat cancer
h/o Influenza
h/o Pneumonia
h/o Bronchitis
h/o COPD
h/o Patients under treatment for any disease other than PT.
Pregnant and Lactating mothers
h/o HIV positive and AIDS.
Other than Category 1 pulmonary TB.
If the participant developed with any ADR after taking the standard or Trial drug.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assessing the Bio-enhancing activity of the trial drug by HPLC method in the First line Anti- Tuberculosis drugs among the Category-1 Pulmonary Tuberculosis patients.  35 days 
 
Secondary Outcome  
Outcome  TimePoints 
Assessing the bio- availability of the First line Anti- Tuberculosis drugs on integration with Thirikaduku chooranam among the Category-1 Pulmonary Tuberculosis patients through HPLC method.  35 days 
 
Target Sample Size   Total Sample Size="6"
Sample Size from India="6" 
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)   12/02/2021 
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    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Pulmonary Tuberculosis is one of the fatal disease which is causing more causalities in a year, as per the WHO guidelines every 1 in 1000 population may have PT in developing countries like India. Due to the modernized civilization, the atmosphere is polluted and the human race has lost its immunity by their habits and living. By thus they are prone to expose various types of multi drug resistant organisms. Entry of any substance is guarded by our own immune systems but the exposures of Tubercular bacteria on low immune persons are highly susceptible to the Pulmonary Tuberculosis (PT). Even though many newer drugs are invented for PT, patients are still in need to bear the burden of long term medication and undesired effect of medicine. So, it is mandatory to wipe out the infection at the early stage. All the ingredients of the trial drug Thirikaduku chooranum are proved separately by having the Anti-microbial and Anti-inflammatory actions in various pre-clinical trials. And 2 of them are having piperine as the marked compound. Also this medicine was widely used in practice for above mentioned disease for so long period. Hence, it is my duty to prove the bio enhancing activity and to document the safety and add on effect of the trial drug along with anti-tuberculosis drugs. . Primary objective To evaluate the bio enhancing activity of Thirikaduku chooranam along with the First line Anti- Tuberculosis drugs among the Category-1 Pulmonary Tuberculosis patients through HPLC method. Secondary objective To evaluate the bio- availability of the First line Anti- Tuberculosis drugs on integration with Thirikaduku chooranam among the Category-1 Pulmonary Tuberculosis patients through HPLC method. Simple randomization applied Arm 1subjects will receive the DOTS First line Anti- Tuberculosis drugs as standard; Simple randomization applied Arm 2 subjects will receive the TKC Twice daily for 14 days along with DOTS First line Anti- Tuberculosis drugs. After the 7 days of drug holiday for the trial drug, the Crossover will be performed and Arm 1& 2 will receive the interchanged medicines respectively for another 14 days. Here the standard drug will be continued during the drug holiday; only the trial drug will be stopped on the holiday period. Blood samples will be collected on first day before starting the trial drug to evaluate the bio availability of the standard drug, then day 14 and day 35 also blood samples will be collected to assess the bio-enhancing activity of the trial drug and bio- availability of the first line Anti- Tuberculosis drug.

 
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