A study to evaluate the Bio-enhancing activity of Siddha drug Thirikaduku Chooranam along with Anti- Tuberculosis drugs among the Pulmonary Tuberculosis patients.
- Conditions
- Other specified respiratory disorders,
- Registration Number
- CTRI/2021/02/031206
- Lead Sponsor
- The Director General
- 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 objectiveTo 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 6
Patients under DOTS ( Anti- Tuberculosis) Therapy Category 1 for new smear positive patients with pulmonary TB.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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
Trial Locations
- Locations (1)
General OPD, Clinical Department, Siddha Clinical Research Unit, Tirupati
🇮🇳Chittoor, ANDHRA PRADESH, India
General OPD, Clinical Department, Siddha Clinical Research Unit, Tirupati🇮🇳Chittoor, ANDHRA PRADESH, IndiaDr K NandhagopalPrincipal investigator8281417248drnandhagopalsiddha@gmail.com