CTRI/2022/05/042586尚未招募2 期
Role of Vitamin C supplement as an adjunct to tuberculosis treatment in new smear sputum positive pulmonary tuberculosis – An exploratory trial
ICMR National Institute for Research in Tuberculosis0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Adult patients aged between 18 – 60 years (both ages inclusive).
- •Patients should have at least two sputum smear samples positive for tubercle bacilli (at least 1+).
- •Newly diagnosed, previously untreated, uncomplicated, sputum smear-positive, pulmonary tuberculosis (or with less than 7 days of ATT).
- •Sputum sensitive to INH and RIF
- •Willing for study procedures
- •Patients should be residing in or around clinical trial sites geographical location.
- •A chest X-ray picture which in the opinion of the Investigator is compatible with tuberculosis
- •Female participants of childbearing potential must have a negative urine pregnancy test and agree to use a highly effective method of birth control (i.e. tubal ligation, vaginal diaphragm, intrauterine device, condom or sponge with spermicide, oral contraceptives, contraceptive implant, combined hormonal patch, combined injectable contraceptive or depot-medroxyprogesterone acetate, partner(s) has had a vasectomy) throughout the treatment period in the trial.
- •Patient should express willingness to attend the treatment centre for supervised treatment
- •Patient should express willingness to give written informed consent prior to all trial-related procedures including HIV testing.
- •No history of intolerance, allergy or contraindication to any of the drugs to be administered
排除标准
- •TB Patients with body weight less than 30 kgs
- •Clinically significant evidence of extrapulmonary tuberculosis (miliary tuberculosis, abdominal tuberculosis, urogenital tuberculosis, osteoarthritic tuberculosis, tuberculous meningitis), as judged by the investigator.
- •Uncontrolled Diabetes Mellitus (Hb A1C > 8 %)
- •Patient sero-positive for HIV antibodies, serology tests positive for Hepatitis B surface antigen or Hepatitis C virus antibody
- •Pregnancy or lactating females
- •On treatment with immunosuppressive drugs
- •Glucose 6-phosphate dehydrogenase deficiency
- •Clinical and /social condition deemed unsuitable/ unsafe for participation in study
- •Evidence of clinically significant metabolic, respiratory ( other than TB) gastrointestinal, neurological, psychiatric or endocrine diseases, malignancy, or other abnormalities/serious illness (other than the indication being studied).
- •Previous history of tuberculosis.
- •Known or suspected alcohol dependence within the past 6 months (audit score of 8 or more) or drug abuse, that is, in the opinion of the investigator, sufficient to compromise the safety or cooperation of the patient.
- •Patients with hepatic or renal disease as evidenced by clinical or biochemical abnormalities i.e., history of liver disease, current ALT > 2.5 times ULN or total bilirubin concentration >1.2 times ULN, Serum Creatinine >1.2 mg/dL, Blood Urea >43 mg/dL
- •Haemoglobin concentration <7.0 g/dL or platelet count <150,000/mm3, or white blood cell count <4500 cells/µL
- •Use of any therapeutic agents known to alter any major organ function (e.g., barbiturates, opiates, phenothiazines, cimetidine) within 30 days prior to dosing.
研究者
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