Comparing the efficacy of Saptaparna Ghanvati and Saptaparna Swaras in treating Asthma - COPD Overlapping Syndrome

Phase 2

Conditions: Health Condition 1: J441- Chronic obstructive pulmonary disease with (acute) exacerbation

Registration Number: CTRI/2024/08/072605

Lead Sponsor: All India Institute Of Ayurveda

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Observed changes (10 to 20% approximately) in Pulmonary Function Test (Including FEV1 FEV1/FVC) Lungs function status measured by forced expiratory volume in 1 second (FEV1) in patients of ACOSTimepoint: Baseline <br/ ><br>After 15 days <br/ ><br>After 30 days <br/ ><br>After 45 days <br/ ><br>After 60 days <br/ ><br> <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1 Change in <br/ ><br>A)COPD assessment test score <br/ ><br>B)Modified Medical Research Council(mMRC) questionnaire <br/ ><br>C) St George Respiratory disease questionnaire <br/ ><br>D)SF-36 questionnaire(COPD specific) <br/ ><br>2)IgE <br/ ><br>3)chest X-ray (PA view) <br/ ><br>4) Exercise tolerance measured by 6 Minute Walk Distance(6MWD)Time Frame 1 month <br/ ><br>5)Exercise tolerance measured by Oxygen saturation Time Frame 1 month <br/ ><br>6)Exercise tolerance measured by Level of dyspnea BODE Index <br/ ><br>Timepoint: Baseline <br/ ><br>After 60 days