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临床试验/CTRI/2021/08/035627
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

All India Institute Of Ayurveda0 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

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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