None listed
Conditions
Brief summary
The general objective of the present study is to evaluate the efficacy and safety of four Myanmar medicinal plants on tuberculosis patients, both in terms of therapeutics (sputum conversion and chest X-ray improvement, etc.). A double-blind randomized controlled trial will be carried out on 300 Category II pulmonary tuberculosis patients to deliver standard anti-TB drugs for CAT II therapy plus capsule containing traditional medicine for 150 patients in one group. Another group will receive CAT II therapy with placebo capsule containing 500 mg starch. The capsules of placebo will look similar to the capsule of traditional medicine. Subjects will be recruited from the Outpatient Departments/National TB Program areas. Baseline demographic characteristics, clinical and laboratory investigations will be done at the start of patient recruitment and will be recorded in all 11 visits (screening visit, day of initiation of the trial, follow-up visits in weeks from initiation of treatment - 1, 4, 8, 12, 16, 20, 24, 28, 32). They will be instructed to consume 3 capsules once a day (evening). Medication compliance will be documented by pill counting at all visits. Unused medication will be checked and taken back. Treatment evaluation will be assessed by sputum clearance time, radiographic improvement, weight gain, incidence of adverse events by each visit. The efficacy and safety data will be analysed using ‘Intention to Treat’ analysis. Statistical analysis will be done using Chi-squared test. The level of significance for all analysis will be taken as p<0.05. Interim analysis of recruited patients will be carried out at three monthly intervals. Multivariable logistic regression analysis will be performed. The research findings will provide national TB programme to support treatment of TB by traditional medicine and help in prevention of MDR-TB.
Interventions
Traditional medicine (four plant extracts prepared in two capsules) plus standard category II regime (4 FDC - Rifampicin plus Isoniazid plus Pyrazinamide, Ethambutol plus Injection Streptomycin) for 150 category II pulmonary TB patients.
The trial drugs contain alkaloids, flavonoids and tannins. One dose contains plant 1 extract 233 mg, plant 2 extract 96 mg, plant 3 extract 34 mg and plant 4 extract 10.4 mg.plant 1 is Azardichata indica , plant 2 is Desmodium triquetrium plant 3 is Alpinia gala
Traditional medicine (four plant extracts prepared in two capsules) plus standard category II regime (4 FDC - Rifampicin plus Isoniazid plus Pyrazinamide, Ethambutol plus Injection Streptomycin) for 150 category II pulmonary TB patients. The trial drugs contain alkaloids, flavonoids and tannins. One dose contains plant 1 extract 233 mg, plant 2 extract 96 mg, plant 3 extract 34 mg and plant 4 extract 10.4 mg.plant 1 is Azardichata indica , plant 2 is Desmodium triquetrium plant 3 is Alpinia galaca, and plant 4 is Acorus calamus. All drugs will be given once a day at evening for 8 months duration. The monitoring will be done by counting of capsules returned and family member/voluntary health workers will observe regular taking of trial drugs by subjects.
Sponsors
WHO (Technical service agreement)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
- Sputum smear positive patients at the start of Cat II regime at TB centres under National Tuberculosis Control Programme
Exclusion criteria
a) Severe liver, kidney and/or bone marrow disorders as diagnosed by medical officer based on biochemical laboratory tests (Blood for complete picture, liver function tests, renal function tests) b) History of diabetes, hypertension, hepatitis B infection, hepatitis C infection, HIV c) History of taking steroids or anti-cancer drugs within one month d) Acute medical or surgical complications which require hospitalization e) Pregnancy
Outcome results
None listed