CTRI/2024/08/072605尚未招募2 期
Evaluating the clinical efficacy of Saptaparna Ghanvati and Saptaparna Swaras in the management of Asthma COPD Overlapping Syndrome (ACOS) Tamakshwasa A comparative Randomised Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
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
- •1)patients of all gender of age between 21-65 years
- •2)Having sign and symptoms of Tamakshwasao or ACOS swasakruchhrata (dyspnea) kanthodhwansa (speak with difficulty) kasa (cough) ghurghurka sabda (wheezing OR rhonchi)
- •3. Diagnosed patient of ACOS on the basis of spirometry
- •A)Post bronchodilator increase of forced expiratory volume in 1 second (FEV1) more than or equal to 12% and more than or equal to 400 mL and eosinophilia in sputum in addition to a personal history of asthma
- •B) High total immune globulin E (IgE) personal history of atopy and a post bronchodilator increase of FEV1 more than or equal to 12% and more than or equal to 200 mL on more than or equal to 2 occasions
- •C) History of evidence of atopy elevated total IgE aged more than or equal to 40 years smoking more than 10 pack-years post-bronchodilator FEV1 less than 80% predicted and FEV1/forced vital capacity (FVC) less than 70%.
- •4. Not undergoing exercise training program or any other lung rehabilitation therapy.
- •5. Patient having allergic diseases or any family history of allergic diseases.
排除标准
- •EXCLUSION CRITERIA:
- •1.ACOS with life threatening complications like cor-pulmonale, respiratory failure, pneumothorax and polycythemia.
- •2.Any history of previous chronic infectious respiratory disease like tuberculosis, URTI, acute bronchitis, pneumonia.
- •3.Patient taking steroid therapy (systemic or inhaled corticosteroid)
- •4 Post-bronchodilator FEV1 less than 50% predicted
- •5.Diagnosis of renal or cardiac asthma.
- •6.History of cystic fibrosis.
- •7.Past or current malignancy
- •8.Pregnant ladies and lactating mothers.
- •9.History of any adverse drug reactions to any ingredient of the drug.
- •10.Patients having positive HIV1 and 2 or positive Hepatitis B.
- •11.Patients having end stage hepatic dysfunction(defined aspartate aminotransferase (AST) and or alanine aminotransferase (ALT) more than 4 times of the upper normal limit) or severe renal dysfunction(defined as S. creatinine more than 1.2 mg/dl),severely compromised cardiac function (EF less than 30%)
- •11.Patient with grade 2 hypertension or more
研究者
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