Ayurvedic therapy in the management of chronic obstructive pulmonary disease with Brihatkataphaladi Vati, Vasadi Kashaya, and polyherbal nebulisation.

Efficacy of Add-on Brihatkataphaladi Vati, Vasadi Kashaya, and Polyherbal Nebulization to Standard Care in the Management of Chronic Obstructive Pulmonary Disease (Tamaka Shwasa) A Randomised Placebo-Controlled Clinical Trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/05/111230

Enrollment

Registered

2026-05-27

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

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.Clinically stable (no acute exacerbation in last 4 weeks) cases diagnosed with Chronic Obstructive Pulmonary Disease as per GOLD guidelines based on FEV1/FVC below 0.70 and Tamaka Shwasa as per Ayurvedic texts 2.Participants aged from 40 to 80 years irrespective of gender. 3.Participants getting conventional treatment as per allopathic standards. 4.GOLD grade I II and III. 5.Participants willing for the trial and ready to give written consent

Exclusion criteria

Exclusion criteria: 1.Participants not willing for the trial. 2.Participants having bronchial asthma. 3.Participants with other respiratory complications like pulmonary tuberculosis, pneumothorax, pneumonia, cystic fibrosis, interstitial lung disorder, and lung cancer. 4.Participants who have a history of myocardial infarction, heart failure, acute ischemic coronary disease, unstable angina, or severe cardiac arrhythmia within last 6 months. 5.Participants suffering from accelerated HTN (more than 160/100 mmHg), Diabetes (FBS more than 150 mg/dl) 6.GOLD grade IV (FEV1% below 30% of predicted). 7.Participants not getting conventional treatment as per allopathic standards. 8.Participants requiring long-term oxygen therapy. 9.Participants suffering from major systemic illness necessitating long-term treatment (RA, Malignazcy) 10.Participants undergoing regular treatment for any other severe illness.

Design outcomes

Primary

Measure	Time frame
Change in COPD(CA22) symptom severity from baseline to end of treatment, assessed using a validated tool such as COPD Assessment Test (CAT) score (mean changes from baseline to end of treatment).Timepoint: 90 days	—

Secondary

Measure	Time frame
1. Improvement in FEV1 2. Improvement in FEV1/FVC ratio 3.Frequency and severity of exacerbations during the study period (Frequency of hospitalisations from baseline to end of treatment). 4.Reduction in use of rescue medication (e.g., short-acting bronchodilators) (Frequency of rescue medicines consumed from baseline to end of treatment). 5.Improvement in Ayurvedic symptomatology (e.g., Shwasakrichhrata, Kasa, Ghurghuraka) using a structured Ayurvedic symptom scoring scale (mean changes from baseline to end of treatment). 6.Safety and tolerability assessed through clinical monitoring and laboratory investigations (e.g., CBC, LFT, KFT) (mean changes from baseline to end of treatment). Timepoint: 90 days	—

Measure

Time frame

1. Improvement in FEV1 2. Improvement in FEV1/FVC ratio 3.Frequency and severity of exacerbations during the study period (Frequency of hospitalisations from baseline to end of treatment). 4.Reduction in use of rescue medication (e.g., short-acting bronchodilators) (Frequency of rescue medicines consumed from baseline to end of treatment). 5.Improvement in Ayurvedic symptomatology (e.g., Shwasakrichhrata, Kasa, Ghurghuraka) using a structured Ayurvedic symptom scoring scale (mean changes from baseline to end of treatment). 6.Safety and tolerability assessed through clinical monitoring and laboratory investigations (e.g., CBC, LFT, KFT) (mean changes from baseline to end of treatment). Timepoint: 90 days

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Countries

India

Contacts

Public ContactMaya Darji

Institute of Teaching and Research in Ayurveda

mandipgoyal@itra.edu.in9427572306

Outcome results