An interventional study of Withania somnifera Root Powder and Starch Placebo Capsules in Asthma, sponsored by Aligarh Muslim University. Completed at 1 site in India. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Aligarh Muslim University · Not applicable, Interventional, and Treatment
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.
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.
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's enrollment of 120 is above the median of 78 across 3,341 interventional studies indexed under Asthma.
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Exclusion Criteria:
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
Participants received standard asthma treatment plus starch placebo capsules orally for 10 weeks.
Other: Starch Placebo Capsules · Drug: Standard Asthma Treatment
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
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 were administered orally for 10 weeks in addition to standard asthma treatment.
Standard asthma treatment included inhaled corticosteroid (fluticasone) and long-acting beta-agonist therapy according to the treating physician's prescription.
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.
Time frame: Baseline and after 10 weeks of intervention
Change in Total Antioxidant Capacity
Total antioxidant capacity of plasma was assessed using the ferric reducing antioxidant power (FRAP) assay before and after the intervention.
Time frame: Baseline and after 10 weeks of intervention
Plan to share: No — Individual participant data will not be shared because no prospective IPD-sharing plan was established for this study. Participant-level data will be maintained confidentially in accordance with institutional and ethical requirements.
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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Aligarh Muslim University