Withania Somnifera for Moderate-to-Severe Persistent Asthma (WISTA)
Study on Anti-oxidative and Anti-Inflammatory Effects of Certain Herbs for Inflammatory Lung Diseases
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Uttar Pradesh
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Aligarh, Uttar Pradesh, India, 202001
- Aligarh Muslim University
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Withania somnifera Treatment Group
Participants received standard asthma treatment plus Withania somnifera root powder capsules, 300 mg orally twice daily for 10 weeks.
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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.
Standard asthma treatment included inhaled corticosteroid (fluticasone) and long-acting beta-agonist therapy according to the treating physician's prescription.
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Comparatore placebo: Placebo Group
Participants received standard asthma treatment plus starch placebo capsules orally for 10 weeks.
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Standard asthma treatment included inhaled corticosteroid (fluticasone) and long-acting beta-agonist therapy according to the treating physician's prescription.
Starch placebo capsules were administered orally for 10 weeks in addition to standard asthma treatment.
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Comparatore attivo: Control Group
Participants received standard conventional asthma treatment, including inhaled corticosteroid (fluticasone) and long-acting beta-agonist therapy, according to the treating physician's prescription.
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Standard asthma treatment included inhaled corticosteroid (fluticasone) and long-acting beta-agonist therapy according to the treating physician's prescription.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in FEV1 Percent Predicted
Lasso di tempo: Baseline and after 10 weeks of intervention
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Forced expiratory volume in one second (FEV1) percent predicted was measured by spirometry to assess lung function before and after the intervention.
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Baseline and after 10 weeks of intervention
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Total Antioxidant Capacity
Lasso di tempo: Baseline and after 10 weeks of intervention
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Total antioxidant capacity of plasma was assessed using the ferric reducing antioxidant power (FRAP) assay before and after the intervention.
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Baseline and after 10 weeks of intervention
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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IECJNMC/628
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
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