Withania Somnifera for Moderate-to-Severe Persistent Asthma

NCT07787507 | Completed

• 1 other identifier: IECJNMC/628
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma

Keywords

Withania somnifera; Ashwagandha; Complementary Therapy; Moderate-to-Severe Persistent Asthma

Outcome Measures

Primary Outcomes (1)

• Change in FEV1 Percent Predicted

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

  Baseline and after 10 weeks of intervention

Secondary Outcomes (1)

• Change in Total Antioxidant Capacity

  Baseline and after 10 weeks of intervention

Study Arms (3)

Withania somnifera Treatment Group

EXPERIMENTAL

Participants received standard asthma treatment plus Withania somnifera root powder capsules, 300 mg orally twice daily for 10 weeks.

Dietary Supplement: Withania somnifera Root Powder; Drug: Standard Asthma Treatment

Placebo Group

PLACEBO COMPARATOR

Participants received standard asthma treatment plus starch placebo capsules orally for 10 weeks.

Other: Starch Placebo Capsules; Drug: Standard Asthma Treatment

Control Group

ACTIVE COMPARATOR

Participants received standard conventional asthma treatment, including inhaled corticosteroid (fluticasone) and long-acting beta-agonist therapy, according to the treating physician's prescription.

Drug: Standard Asthma Treatment

Interventions

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.

Withania somnifera Treatment Group

Starch Placebo Capsules OTHER

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

Placebo Group

Standard Asthma Treatment DRUG

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

Control Group; Placebo Group; Withania somnifera Treatment Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Aligarh Muslim University: lead

Study Sites (1)

Aligarh Muslim University

Aligarh, Uttar Pradesh, 202001, India

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Research Scholar

Study Record Dates

• First Submitted: August 23, 2026
• First Posted: August 26, 2026
• Study Start: February 15, 2026
• Primary Completion: June 15, 2026
• Study Completion: June 15, 2026
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)