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
|
|
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
|
|
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. |