Efficacy of Shatpala Ghrita and Ashwagandha Kshara in the management of chronic obstructive pulmonary disease (Tamaka Shwasa)

Efficacy of Shatpala Ghrita and Ashwagandha Kshara in the management of chronic obstructive pulmonary disease (Tamaka Shwasa) – A single arm open labelled clinical trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/03/041491

Enrollment

Registered

2022-03-30

Start date

Unknown

Completion date

Unknown

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Symptomatological criteria - patients having history of respiratory signs and symptoms mentioned in modern texts such as chronic cough, increased sputum production, exertional dyspnea, wheezing, chest tightness, Recurrent lower respiratory tract infections with a history of exposure to risk factors ( Host factors – Genetic factors, Tobacco smoke, Occupation, Indoor/outdoor pollution ) 2. Spirometric criteria – FEV1/FVC 30% and =80%. 3. Sex: Patients of either sex 4. Age group: 30 – 70 years 5. Patients willing to participate in trial

Exclusion criteria

Exclusion criteria: 1. Age below 30 years and above 70 years 2. Pregnant and lactating women 3. Peak expiratory flow rate 4. Patients having respiratory complications like Core-pulmonale, and diseases like Active Pulmonary TB, Pneumonia, status asthmaticus, Cystic fibrosis, Pleural effusion, Pneumothorax, Lung cancer and other systemic diseases like Severe anaemia, Renal failure, Cardiovascular disease. 5. Patients suffering from malignant and accelerated hypertension (160/100 mm of Hg), coronary artery disease, uncontrolled diabetes (HbA1c > 10%). 6. Patient undergoing regular treatment for any other severe illness and also patient on prolonged corticosteroid use.

Design outcomes

Primary

Measure	Time frame
It will relief in the symptoms of COPD i. e. chronic cough, chronic sputum production, exertional dyspnoea, wheezing and chest tightness.Timepoint: on 0 days & after 8 weeks.	—

Secondary

Measure	Time frame
It will produce improvement in mMRC (Modified British Medical Research Council) Dyspnea scale, CAT (COPD assessment test) scale, GOLD criteria of spirometry, BODE index and SF-36 questionnaire for Quality of life.Timepoint: on 0 days & after 8 weeks.	—

Countries

India

Contacts

Public ContactDr Mandip Goyal

Institute of Teaching and Research and Ayurveda

mandipgoyal@ayurveduniversity.com09427572306

Outcome results