CTRI/2021/08/035627尚未招募2 期
EVALUATING CLINICAL EFFICACY OF MANASHILADI GHRITA AND ALSTONIASCHOLARIS IN THE MANAGEMENT OF ASTHMA COPD OVERLAPPING SYNDROME(ACOS) WITH SPECIAL REFERENCE TO TAMAKASHWASA A COMPARATIVERANDOMISED DOUBLE ARM CLINICAL TRIA
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
- •3. Having sign and symptoms of Tamak Shwas/ ACOâ?? swasakruchhrata (dyspnoea), kanthodhwansa (speak with difficulty), kasa (cough), ghurghurka sabda ( wheezing /rhonchi)
- •4. Pulmonologist diagnosed patient of ACO • Post bronchodilator increase of forced expiratory volume in 1 second (FEV1) >= 12% and >= 400 mL, and eosinophilia in sputum in addition to a personal history of asthma. • High total immune globulin E (IgE), personal history of atopy, and a post bronchodilator increase of FEV1 >= 12% and >= 200 mL on >= 2 occasions. • History of evidence of atopy, elevated total IgE, aged >= 40 years, smoking > 10 pack-years, post-bronchodilator FEV1 < 80% predicted and FEV1/forced vital capacity (FVC) < 70%.
- •5. Not undergoing exercise training program or any other lung rehabilitation therapy.
- •6. BMI < 25
- •7. Smokers and ex-smoker with smoking history>=10 pack-years.
- •8. Patient having allergic diseases or any family history of allergic diseases.
- •9. Ability to demonstrate compliance with handy-inhaler, a salbutamol Meter Dose Inhaler, and the activity monitor; perform acceptable Pulmonary Function Tests; an exercise stress test and can follow study procedures. (Note: GOLD-Global Initiative for Chronic Obstructive Lung Diseases, MRC- Medical Research Council).
- •10. Vitamin D3 deficient : Serum 25(OH)D <30ng/ml
排除标准
- •a. ACOS with life threatening complications like cor-pulmonale, respiratory failure, pneumothorax and polycythemia.
- •b. Any history of previous chronic infectious respiratory disease like tuberculosis, URTI, acute bronchitis, pneumonia.
- •c. Patient taking steroid therapy from long duration (systemic or inhaled corticosteroid)
- •d. Diagnosis of renal or cardiac asthma.
- •e. History of cystic fibrosis.
- •f. Past or current malignancy within 5years.
- •g. Pregnant ladies and lactating mothers.
- •h. History of any adverse drug reactions.
- •i. Patients having positive HIV1 and 2 or positive Hepatitis B.
- •j. Patients having end stage hepatic dysfunction (defined aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 4 times of the upper normal limit) or severe renal dysfunction (defined as S. creatinine > 1.2 mg/dl),severely compromised cardiac function (EF < 30% ).
- •k. Patient with poorly controlled Hypertension ( > 180 / 100 mm Hg). l. BMI >25 kg/m2
研究者
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