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Completed

NCT Number: NCT07787507

Withania Somnifera for Moderate-to-Severe Persistent Asthma

This randomized, double-blind, placebo-controlled study evaluated Withania somnifera root powder as a complementary therapy in adults with moderate-to-severe persistent asthma receiving standard asthma treatment. Participants were assigned to standard treatment alone, standard treatment plus placebo, or standard treatment plus Withania somnifera root powder for 10 weeks. Lung function, asthma control, quality of life, systemic oxidative stress, and inflammatory and allergic biomarkers were assessed before and after the intervention to evaluate the potential additional benefits of Withania somnifera in asthma management.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aligarh Muslim University

Aligarh, Uttar Pradesh, 202001, India

About this study

This randomized, double-blind, placebo-controlled clinical study was conducted at Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh, India. Adults aged 18-50 years with moderate-to-severe persistent asthma were included in the study. Eligible participants were non-smokers and were receiving standard asthma medication. Patients with recent respiratory tract infection, pregnancy or lactation, serious comorbid conditions, or hospitalization within the previous month were excluded.

Participants were allocated using computer-generated randomization to three groups: a control group receiving conventional asthma treatment, a placebo group receiving conventional treatment plus starch capsules, and a Withania somnifera-treated group receiving conventional treatment plus Withania somnifera root powder capsules. The Withania somnifera intervention consisted of 300 mg root powder administered orally twice daily for 10 weeks.

Clinical assessments were performed at baseline and after the 10-week intervention. Lung function was evaluated by spirometry using FEV1 percent predicted, FVC percent predicted, and the FEV1/FVC ratio. Asthma control was assessed using the Asthma Control Test, and quality of life was evaluated using the Asthma Quality of Life Questionnaire.

Blood samples were collected for assessment of systemic oxidative stress, inflammation, and allergic markers. Evaluations included total antioxidant capacity, malondialdehyde, total sulfhydryl groups, neutrophil and eosinophil percentages, and circulating IL-4, IL-8, IL-13, IL-17A, and IgE levels. Plasma samples were stored at -80°C until laboratory analysis.

The study was reviewed and approved by the Institutional Ethical Committee of Jawaharlal Nehru Medical College, Aligarh Muslim University (IECJNMC/628), and written informed consent was obtained from the participants.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 to 50 years Moderate to severe persistent asthma Non-smokers Receiving standard asthma medications for no more than one month

Exclusion criteria

  • Recent respiratory tract infection Pregnant or lactating women Serious comorbid conditions Hospitalization within the previous one month

Treatment and study plan

Withania somnifera Root Powder

Dietary Supplement

Withania somnifera root powder was administered orally in capsule form at a dose of 300 mg twice daily (total daily dose 600 mg) for 10 weeks, in addition to standard asthma treatment.

Starch Placebo Capsules

Other

Starch placebo capsules were administered orally for 10 weeks in addition to standard asthma treatment.

Standard Asthma Treatment

Drug

Standard asthma treatment included inhaled corticosteroid (fluticasone) and long-acting beta-agonist therapy according to the treating physician's prescription.

Primary outcomes

  1. Change in FEV1 Percent Predicted

    Time frame: Baseline and after 10 weeks of intervention

    Forced expiratory volume in one second (FEV1) percent predicted was measured by spirometry to assess lung function before and after the intervention.

Secondary outcomes

  1. Change in Total Antioxidant Capacity

    Time frame: Baseline and after 10 weeks of intervention

    Total antioxidant capacity of plasma was assessed using the ferric reducing antioxidant power (FRAP) assay before and after the intervention.

Sponsors and collaborators

Lead sponsor

Aligarh Muslim University

Other

Registry information

Official study title

Study on Anti-oxidative and Anti-Inflammatory Effects of Certain Herbs for Inflammatory Lung Diseases

Acronym: WISTA

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 26, 2026
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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